117 results on '"Gabrail, Nashat"'
Search Results
2. Oral decitabine–cedazuridine versus intravenous decitabine for myelodysplastic syndromes and chronic myelomonocytic leukaemia (ASCERTAIN): a registrational, randomised, crossover, pharmacokinetics, phase 3 study
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Garcia-Manero, Guillermo, McCloskey, James, Griffiths, Elizabeth A, Yee, Karen W L, Zeidan, Amer M, Al-Kali, Aref, Deeg, H Joachim, Patel, Prapti A, Sabloff, Mitchell, Keating, Mary-Margaret, Zhu, Nancy, Gabrail, Nashat Y, Fazal, Salman, Maly, Joseph, Odenike, Olatoyosi, Kantarjian, Hagop, DeZern, Amy E, O’Connell, Casey L, Roboz, Gail J, Busque, Lambert, Buckstein, Rena, Amin, Harshad, Randhawa, Jasleen, Leber, Brian, Shastri, Aditi, Dao, Kim-Hien, Oganesian, Aram, Hao, Yong, Keer, Harold N, Azab, Mohammad, and Savona, Michael R more...
- Abstract
The DNA methyltransferase inhibitors azacitidine and decitabine for individuals with myelodysplastic syndromes or chronic myelomonocytic leukaemia are available in parenteral form. Oral therapy with similar exposure for these diseases would offer potential treatment benefits. We aimed to compare the safety and pharmacokinetics of oral decitabine plus the cytidine deaminase inhibitor cedazuridine versus intravenous decitabine. more...
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- 2024
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3. Momelotinib versus danazol in symptomatic patients with anaemia and myelofibrosis (MOMENTUM): results from an international, double-blind, randomised, controlled, phase 3 study
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Verstovsek, Srdan, Gerds, Aaron T, Vannucchi, Alessandro M, Al-Ali, Haifa Kathrin, Lavie, David, Kuykendall, Andrew T, Grosicki, Sebastian, Iurlo, Alessandra, Goh, Yeow Tee, Lazaroiu, Mihaela C, Egyed, Miklos, Fox, Maria Laura, McLornan, Donal, Perkins, Andrew, Yoon, Sung-Soo, Gupta, Vikas, Kiladjian, Jean-Jacques, Granacher, Nikki, Lee, Sung-Eun, Ocroteala, Luminita, Passamonti, Francesco, Harrison, Claire N, Klencke, Barbara J, Ro, Sunhee, Donahue, Rafe, Kawashima, Jun, Mesa, Ruben, Abulafia, Adi Shacham, Al-Ali, Haifa Kathrin, Andreasson, Bjorn, Angona, Anna, Ayala, Rosa, Bang, Soo-Mee, Bank, Bruce, Barraco, Fiorenza, Beggiato, Eloise, Benghiat, Fleur Samantha, Bonifacio, MassimiliaNo, Bories, Claire, Borsaru, Gabriela, Brabrand, Mette, Braester, Andrei, Broliden, Andes, Buxhofer-Ausch, Veronika, Cambier, Nathalie, Caramella, Marianna, Carpentier, Benjamin, Cascavilla, Nicola, Castellano, Maria Giraldo, Chang, Hung, Chen, Chih-Cheng, Cheong, June-Won, Choi, Yunsuk, Choi, Philip, Corsetti, Maria Teresa, Cuadrado, Isabel Montero, Cunningham, Julia, Damaj, Gandhi Laurent, De Stefano, Valerio, Delage, Robert, Delgado, Regina Garcĺa, Diaz, Jose Miguel Torregrosa, Dombi, Péter, Dubruille, Viviane, Egyed, Miklós, El Fassi, Daniel, Elinder-Camburn, Anna, Elli, Elena Maria, Ellis, Martin, Fava, Carmen, Fazal, Salman, Fleischman, Angela, Foltz, Lynda, Fox, Laura, Gabrail, Nashat, Garcĺa-Gutiérrez, Jose Valentĺn, Gerds, Aaron, Girault, Stephane, Gisslinger, Heinz, Gluvacov, Alexandru, Goh, Yeow Tee, Göthert, Joachim, Granacher, Nikki, Grosicki, Sebastian, Gupta, Vikas, Hadjiev (Hadzhiev), Evgeni (Evgueniy), Hafraoui, Kaoutar, Hamed, Aryan, Harrison, Claire, Hasselbalch, Hans, Hauser, Hanns, Heaney, Mark, Hebart, Holger, Hernandez Rivas, Jesus Maria, Higuero Saavedra, Victor, Hillis, Christopher, Hou, Hsin-An, How, Jonathan, Huang, Daniel, Hus, Marek, Illés, Arpad, Isidori, Alessandro, Iurlo, Alessandra, Ivanov, Vadim, Johansson, Peter, Jung, Chul Won, Kiladjian, Jean-Jacques, Kirgner, Ilya, Koren-Michowitz, Maya, Koschmieder, Steffen, Kosztolanyi, Szabolcs Ors, Kreiniz, Natalia, Kuykendall, Andrew, Lambert, Jonathan, Laribi, Kamel, Lascaux, Axelle, Lavie, Noa, Lavie, David, Lazaroiu, Mihaela, Leahy, Michael, Lech-Maranda, Ewa, Lee, Sung-Eun, Lee, Won Sik, Legrand, Ollivier, Lemoli, Roberto, Liang, James, Lim, Sung-Nam, Loschi, Michael, Lucchesi, Alessandro, Macarie, Ioan, Marolleau, Jean-Pierre, Martelli, Maurizio, Mayer, Jiri, McCloskey, James, McDermott, Christopher, McLornan, Donal, McMahon, Brandon, Mehta, Priyanka, Mesa, Ruben, Mikala, Gábor, Milojkovic, Dragana, Mineur, Philippe, Mishchenko, Elena, Moon, Joon Ho, Nagy, Zsolt, Narayanan, Srinivasan, O'Connell, Casey, Ocroteala, Luminita, Oh, Stephen, Ojeda-Uribe, Mario, Ong, Kiat Hoe, Otegbeye, Folashade, Palmer, Jeanne, Pane, Fabrizio, Passamonti, Francesco, Patriarca, Andrea, Perkins, Andrew, Pietrantuono, Giuseppe, Plander, Mark, Platzbecker, Uwe, Prasad, Ritam, Prejzner, Witold, Rachow, Tobias, Radinoff, Atanas, Rejtő, László, Rinaldi, Ciro, Robak, Tadeusz, Rodriguez, Maria Angeles Fernandez, Ronson, Aaron, Ross, David, Sacha, Tomasz, Sadjadian, Parvis, Salar, Antonio, Santillana, Guillermo Sanz, Scheid, Christof, Schmidt, Aline, Severinsen, Marianne Tang, Stoeva, Vera, Szwedyk, Paweł, Tiribelli, Mario, Trautmann-Grill, Karolin, Trottier, Amy, Tzvetkov, Nikolay, van Droogenbroeck, Janusz, Vannucchi, Alessandro, Verstovsek, Srdan, Vianelli, Nicola, von Bubnoff, Nikolas, Wolf, Dominik, Woszczyk, Dariusz, Woźny, Tomasz, Wróbel, Tomasz, Xicoy, Blanca, Yeh, Su-Peng, and Yoon, Sung-Soo more...
- Abstract
Janus kinase (JAK) inhibitors approved for myelofibrosis provide spleen and symptom improvements but do not meaningfully improve anaemia. Momelotinib, a first-in-class inhibitor of activin A receptor type 1 as well as JAK1 and JAK2, has shown symptom, spleen, and anaemia benefits in myelofibrosis. We aimed to confirm the differentiated clinical benefits of momelotinib versus the active comparator danazol in JAK-inhibitor-exposed, symptomatic patients with anaemia and intermediate-risk or high-risk myelofibrosis. more...
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- 2023
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4. Prolonged Survival in Bi-Allelic TP53-Mutated (TP53mut) MDS Subjects Treated with Oral Decitabine/Cedazuridine in the Ascertain Trial (ASTX727-02)
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Savona, Michael R., McCloskey, James K, Griffiths, Elizabeth A., Yee, Karen, Zeidan, Amer M., Al-Kali, Aref, Deeg, Joachim, Patel, Prapti, Sabloff, Mitchell, Keating, Mary-Margaret, Dao, Kim-Hien, Zhu, Nancy, Gabrail, Nashat Y., Fazal, Salman, Maly, Joseph J., Odenike, Olatoyosi, Kantarjian, Hagop, DeZern, Amy E., O'Connell, Casey L., Roboz, Gail J., Busque, Lambert, Buckstein, Rena, Amin, Harshad, Randhawa, Jasleen K., Leber, Brian, Oganesian, Aram, Chan, Winny, Hao, Yong, Azab, Mohammad, and Garcia-Manero, Guillermo more...
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- 2022
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5. Prolonged Survival in Bi-Allelic TP53-Mutated (TP53mut) MDS Subjects Treated with Oral Decitabine/Cedazuridine in the Ascertain Trial (ASTX727-02)
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Savona, Michael R., McCloskey, James K, Griffiths, Elizabeth A., Yee, Karen, Zeidan, Amer M., Al-Kali, Aref, Deeg, Joachim, Patel, Prapti, Sabloff, Mitchell, Keating, Mary-Margaret, Dao, Kim-Hien, Zhu, Nancy, Gabrail, Nashat Y., Fazal, Salman, Maly, Joseph J., Odenike, Olatoyosi, Kantarjian, Hagop, DeZern, Amy E., O'Connell, Casey L., Roboz, Gail J., Busque, Lambert, Buckstein, Rena, Amin, Harshad, Randhawa, Jasleen K., Leber, Brian, Oganesian, Aram, Chan, Winny, Hao, Yong, Azab, Mohammad, and Garcia-Manero, Guillermo more...
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- 2022
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6. PP01.87 A Phase 2/3 Study of Fianlimab plus Cemiplimab versus Cemiplimab in Patients with Advanced NSCLC with Tumors Expressing PD-L1 ≥50%
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Faulkner, Neil, Nair, Santosh, Gabrail, Nashat, Kunta, Gopal, Ibrahim, Emad, Dreisbach, Luke, Brungs, Daniel, Mani, Jayakumar, Ghattas, Maria, Li, Siyu, Salvati, Mark, Lowy, Israel, Hiley, Tara, Fury, Matthew G., and Paoluzzi, Luca more...
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- 2024
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7. PP01.85 A Phase 2/3 Study of Fianlimab, Cemiplimab, plus Chemotherapy Versus Cemiplimab plus Chemotherapy in First-Line Advanced Non-Small Cell Lung Cancer
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Gabrail, Nashat, Faulkner, Neil, Nair, Santosh, Ibrahim, Emad, Brungs, Daniel, Dreisbach, Luke, Kunta, Gopal, Mani, Jayakumar, Ghattas, Maria, Li, Siyu, Salvati, Mark, Lowy, Israel, Hiley, Tara, Fury, Matthew G., and Paoluzzi, Luca more...
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- 2024
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8. Lisaftoclax (APG-2575) Safety and Activity As Monotherapy or Combined with Acalabrutinib or Rituximab in Patients (pts) with Treatment-Naïve, Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (R/R CLL/SLL): Initial Data from a Phase 2 Global Study
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Davids, Matthew S., Chanan-Khan, Asher, Mudenda, Boyd, Nogaieva, Larysa, Kriachok, Iryna, Usenko, Hanna, Ivanov, Vladimir, Kyselova, Olena, Perekhrestenko, Tetiana, Muzhychuk, Ivan, Myasnikov, Alexander, Maslyak, Zvenyslava, Proidakov, Andrew, Uspenskaya, Olga, Borisenkova, Elena, Marlton, Paula, Siddiqi, Tanya, Winter, Allison, Lysa, Tamila, Bakirov, Bulat, Fu, Lei, Chen, Zi, Yu, Min, Li, Mingyu, Glass, Laura, Ahmad, Mohammad, Karpenko, Olena, Osipov, Iurii, De, Asit, Paudyal, Ben, Wang, Hengbang, Winkler, Robert, Gabrail, Nashat, Ganju, Vinod, Konstantinova, Tatiana S., Samoylova, Olga S., Yang, Dajun, and Zhai, Yifan more...
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- 2022
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9. Lisaftoclax (APG-2575) Safety and Activity As Monotherapy or Combined with Acalabrutinib or Rituximab in Patients (pts) with Treatment-Naïve, Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (R/R CLL/SLL): Initial Data from a Phase 2 Global Study
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Davids, Matthew S., Chanan-Khan, Asher, Mudenda, Boyd, Nogaieva, Larysa, Kriachok, Iryna, Usenko, Hanna, Ivanov, Vladimir, Kyselova, Olena, Perekhrestenko, Tetiana, Muzhychuk, Ivan, Myasnikov, Alexander, Maslyak, Zvenyslava, Proidakov, Andrew, Uspenskaya, Olga, Borisenkova, Elena, Marlton, Paula, Siddiqi, Tanya, Winter, Allison, Lysa, Tamila, Bakirov, Bulat, Fu, Lei, Chen, Zi, Yu, Min, Li, Mingyu, Glass, Laura, Ahmad, Mohammad, Karpenko, Olena, Osipov, Iurii, De, Asit, Paudyal, Ben, Wang, Hengbang, Winkler, Robert, Gabrail, Nashat, Ganju, Vinod, Konstantinova, Tatiana S., Samoylova, Olga S., Yang, Dajun, and Zhai, Yifan more...
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- 2022
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10. Real-world effectiveness of palonosetron-based antiemetic regimens: preventing chemotherapy-induced nausea and vomiting
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Schwartzberg, Lee S, Marks, Stanley M, Gabrail, Nashat Y, Geller, Robert B, and Kish, Jonathan
- Abstract
Aim:To evaluate real-world effectiveness of guideline-recommended palonosetron-containing antiemetic regimens in patients receiving highly (HEC) or moderately emetogenic (MEC) chemotherapy. Patients & methods:This retrospective analysis used records of adults receiving first-line chemotherapy and a three-drug palonosetron-containing antiemetic regimen for HEC or palonosetron-containing antiemetic regimen for MEC (carboplatin). Results:A total of 1587 records were evaluated. For HEC and MEC, respectively, chemotherapy-induced nausea and vomiting (CINV) occurred in 40 versus 44 of patient cycles (p 0.01), and unscheduled iv. antiemetics in 41 versus 35 (p < 0.05). A total of 48 of HEC patients versus 42 of MEC patients had CINV-related clinic visits (p 0.05). Conclusion:Palonosetron-containing antiemetic regimens may provide insufficient CINV control. Alternative regimens may improve patient quality of life and reduce healthcare resource utilization. more...
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- 2019
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11. Doxorubicin-loaded nanoparticles for patients with advanced hepatocellular carcinoma after sorafenib treatment failure (RELIVE): a phase 3 randomised controlled trial
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Merle, Philippe, Blanc, Jean-Frederic, Phelip, Jean-Marc, Pelletier, Gilles, Bronowicki, Jean-Pierre, Touchefeu, Yann, Pageaux, Georges, Gerolami, René, Habersetzer, François, Nguyen-Khac, Eric, Casadei-Gardini, Andrea, Borbath, Ivan, Tran, Albert, Wege, Henning, Saad, Amr Shafik, Colombo, Massimo, Abergel, Armand, Richou, Carine, Waked, Imam, Yee, Nelson S, Molé, Audrey, Attali, Pierre, Le Boulicaut, Julie, Vasseur, Bérangère, Moussata, Driffa, Grangé, Jean-Didier, Ratziu, Vlad, Khemissa-Akouz, Faiza, Regnault, Hélène, Dauvois, Barbara, Zarski, Jean-Pierre, Ollivier-Hourmand, Isabelle, Manfredi, Sylvain, Debette-Gratien, Marilyne, Gangloff, Alice, Fontanges, Thierry, Baron, Aurore, Bouattour, Mohamed, Vincent, Julie, Sieghart, Wolfgang, Maieron, Andreas, Peeters, Marc, Delwaide, Jean, Lasser, Luc, Berg, Thomas, Schultheiß, Michael, Zipprich, Alexander, Trojan, Joerg, Ehmer, Ursula, Luppi, Gabriele, Luca, Giovanni, Tamberi, Stefano, Amoroso, Domenico, Alabiso, Oscar, Buonadonna, Angela, Toniutto, Pierluigi, Tamburini, Emiliano, Cubillo, Antonio, Muñoz, Andrés, Guillén, Carmen, Sánchez, Gloria, Manzano, Hermini, Navarro, Victor, Ales, Inmaculada, Massuti, Bartomeu, Dank, Magdolna, Bodoky, György, Kahan, Zsuzsanna, Horváth, Zsolt, Gabrail, Nashat, Ozer, Howard, Galanopoulos, Christos, Hauke, Ralph, Raj, Moses, Harputluoglu, Hakan, Sevinc, Alper, Goker, Erdem, Coker, Ahmet, Yalcin, Suayib, Ali, Muhammet, Ata, Ozlem, Tugba, Ilkay, El Kassas, Mohammed, Abdel, Amr, Wakid, Imam, Shamaa, Sameh, El Lahlouby, Nasr, Kohail, Hanaa, Makarem, Jawad, Chehade, Issam, Farhat, Fadi, López, Carlos, and Marín, Miguel more...
- Abstract
Cytotoxic chemotherapy is generally ineffective in patients with hepatocellular carcinoma. We assessed the intravenous perfusion of doxorubicin-loaded nanoparticles in patients with hepatocellular carcinoma in whom previous sorafenib therapy had failed. more...
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- 2019
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12. Reclassification of Ascertain (ASTX727-02) Myelodysplastic Syndrome (MDS) Patients: Outcomes Including Clinical Response, Overall Survival (OS), and Leukemia Free Survival (LFS) Based on IPSS-R and IPSS-M Scoring Systems
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Garcia-Manero, Guillermo, McCloskey, James, Griffiths, Elizabeth A., Zeidan, Amer M., Yee, Karen W.L., Al-Kali, Aref, Deeg, H. Joachim, Patel, Prapti A., Sabloff, Mitchell, Keating, Mary-Margaret, Zhu, Nancy, Gabrail, Nashat Y., Fazal, Salman, Maly, Joseph J., Odenike, Olatoyosi, Kantarjian, Hagop M., DeZern, Amy E., O'Connell, Casey L., Roboz, Gail J., Busque, Lambert, Buckstein, Rena, Amin, Harsh, Randhawa, Jasleen K., Leber, Brian, Lee, Shannon, Chan, Winny, Souza, Sonia, Sano, Yuri, Keer, Harold N., and Savona, Michael R. more...
- Abstract
Background:
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- 2023
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13. A multi-cohort phase I/IIa clinical trial to evaluate the safety, tolerability, and pharmacokinetics of TST001 administered as a monotherapy, with nivolumab or standard of care in patients with locally advanced or metastatic solid tumors: TransStar101.
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Janjigian, Yelena Y., Sun, Weijing, Rocha Lima, Caio Max Sao Pedro, Shah, Satish, Scott, Aaron James, Monga, Dulabh K., Kundranda, Madappa N., Sher, Amna Falak, Gold, Philip Jordan, Berlin, Jordan, Patel, Manish R., Alese, Olatunji B., Hamilton, Erika P., Cecchini, Michael, Van Tine, Brian Andrew, George, Ben, Mehta, Rutika, Xia, Zhenzhong, Germa, Caroline, and Gabrail, Nashat Y. more...
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- 2023
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14. Phase 1b study of batiraxcept (AVB-S6-500, BT) plus gemcitabine (G) and nab-paclitaxel (NP) as first-line treatment (1L) for advanced pancreatic adenocarcinoma (PDAC).
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Sahai, Vaibhav, Oberstein, Paul Eliezer, Krishnamurthi, Smitha S., Gabrail, Nashat Y., Fountzilas, Christos, Brenner, Warren S., Wainberg, Zev A., Yan, Hongxia, McIntyre, Gail, Lopez, Charles D., Mettu, Niharika B., and Geller, Robert B. more...
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- 2023
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15. Phase 1/2 dose escalation and dose expansion study of TransCon IL-2 β/γ alone or in combination with pembrolizumab: Initial results from dose escalation.
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Starodub, Alexander, Powderly, John D., Kim, Sung-Bae, Davar, Diwakar, Hill, Andrew Graham, Yeku, Oladapo O., Gabrail, Nashat Y., Krapp, Christian, Pihl, Susanne, Zhang, Ying, Slavsky, Sibel, Torrejon Castro, Davis Y, Uyei, Anne, Singel, Stina Mui, and Kwatra, Vineet more...
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- 2023
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16. Preliminary safety and efficacy of tinengotinib tablets as monotherapy and combination therapy in advanced solid tumors: A phase Ib/II clinical trial.
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Piha-Paul, Sarina A., Goel, Sanjay, Liao, Chih-Yi, Gabrail, Nashat Y., Dayyani, Farshid, Kazmi, Syed Mohammad Ali, Yuan, Yuan, Lavasani, Sayeh Moazami, Fan, Jean, Peng, Peng, Sun, Caixia, Wang, Hui, Hennessy, Katie, Fu, Ximei, Ni, Shumao, Tan, Hui Xian, Ngo, Brenda, Ru, Qinhua Cindy, Wu, Frank, and Javle, Milind M. more...
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- 2023
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17. A phase 1, first-in-human, open-label, dose escalation and dose expansion study of TST005 in patients with locally advanced or metastatic solid tumors.
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Tolcher, Anthony W., Wu, Xiaohua, Zhang, Jian, Barve, Minal A., Gabrail, Nashat Y., Sommerhalder, David, Rodriguez Rivera, Ildefonso I, Wilks, Sharon, Wu, Yong, Liu, Rujiao, Gao, Shuiping, Valiyil, Akhilkrishna, Sayi, Ntombizodwa, Germa, Caroline, Qi, Charlie, Chen, LEI, Yu, Steven, Yao, Jenny, and Zhu, Xuelian more...
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- 2023
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18. Early efficacy evaluation of ORIN1001, a first in class IRE1 alpha inhibitor, in advanced solid tumors.
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Rimawi, Mothaffar F., Hamilton, Erika P., Hurvitz, Sara A., Marks, Douglas Kanter, Elias, Anthony D., Pluard, Timothy J., Gabrail, Nashat Y., Patterson, John, Greene, Stephanie, and Zeng, Qingping
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- 2023
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19. Real-world efficacy: intravenous palonosetron three-drug regimen for chemotherapy-induced nausea and vomiting with highly emetogenic chemotherapy
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Schwartzberg, Lee S, McLaughlin, Trent, Geller, Robert B, Gabrail, Nashat Y, and Marks, Stanley M
- Abstract
Aim:Real-world palonosetron effectiveness was evaluated in an antiemetic regimen with highly emetogenic chemotherapy (HEC). Patients & methods:In this Phase IV, prospective, multicenter observational study, HEC-treated cancer patients received palonosetron, a neurokinin 1 receptor antagonist, and dexamethasone. Primary objective was to assess complete response (CR) for acute (≤24 h), delayed and overall (≤120 h) chemotherapy-induced nausea and vomiting. Results:Of 159 patients, 65.4 had breast cancer, 64.8 received anthracycline (doxorubicin)-plus-cyclophosphamide-containing chemotherapy; 155 completed one HEC cycle. CR was 60.0 acute, 39.4 delayed and 34.8 overall, and then increased (all phases) in 69 patients completing four HEC cycles. Anthracycline (doxorubicin) plus cyclophosphamide-receiving patients had especially low CR. Conclusion:Even within a recommended three-drug antiemetic regimen, palonosetron may provide suboptimal chemotherapy-induced nausea and vomiting control with HEC in real-world settings. more...
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- 2018
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20. Voxtalisib (XL765) in patients with relapsed or refractory non-Hodgkin lymphoma or chronic lymphocytic leukaemia: an open-label, phase 2 trial
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Brown, Jennifer R, Hamadani, Mehdi, Hayslip, John, Janssens, Ann, Wagner-Johnston, Nina, Ottmann, Oliver, Arnason, Jon, Tilly, Hervé, Millenson, Michael, Offner, Fritz, Gabrail, Nashat Y, Ganguly, Siddhartha, Ailawadhi, Sikander, Kasar, Siddha, Kater, Arnon P, Doorduijn, Jeanette K, Gao, Lei, Lager, Joanne J, Wu, Bin, Egile, Coumaran, and Kersten, Marie José more...
- Abstract
Patients with relapsed or refractory lymphoma or chronic lymphocytic leukaemia have a poor prognosis. Therapies targeting more than one isoform of PI3K, as well as mTOR, might increase antitumour activity. We aimed to investigate the efficacy and safety of voxtalisib (also known as XL765 or SAR245409), a pan-PI3K/mTOR inhibitor, in patients with relapsed or refractory lymphoma, or chronic lymphocytic leukaemia/small lymphocytic lymphoma. more...
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- 2018
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21. Safety and efficacy of selinexor in relapsed or refractory multiple myeloma and Waldenstrom macroglobulinemia
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Chen, Christine, Siegel, David, Gutierrez, Martin, Jacoby, Meagan, Hofmeister, Craig C., Gabrail, Nashat, Baz, Rachid, Mau-Sorensen, Morten, Berdeja, Jesus G., Savona, Michael, Savoie, Lynn, Trudel, Suzanne, Areethamsirikul, Nuchanan, Unger, T. J., Rashal, Tami, Hanke, Tim, Kauffman, Michael, Shacham, Sharon, and Reece, Donna more...
- Abstract
Novel therapies are needed for patients with relapsed or refractory multiple myeloma (MM). We conducted a multicenter, phase 1 study in advanced hematological malignancies to assess the safety, efficacy, and recommended phase 2 dose (RP2D) of oral selinexor, a selective inhibitor of the nuclear export protein XPO1. In the dose-escalation phase, 25 patients with heavily pretreated MM (22) or Waldenstrom macroglobulinemia (3) were administered selinexor (3-60 mg/m2) in 8 or 10 doses per 28-day cycle. In the dose-expansion phase, 59 patients with MM received selinexor at 45 or 60 mg/m2 with 20 mg dexamethasone, twice weekly in 28-day cycles, or selinexor (40 or 60 mg flat dose) without corticosteroids in 21-day cycles. The most common nonhematologic adverse events (AEs) were nausea (75%), fatigue (70%), anorexia (64%), vomiting (43%), weight loss (32%), and diarrhea (32%), which were primarily grade 1 or 2. The most common grade 3 or 4 AEs were hematologic, particularly thrombocytopenia (45%). Single-agent selinexor showed modest efficacy with an objective response rate (ORR) of 4% and clinical benefit rate of 21%. In contrast, the addition of dexamethasone increased the ORR with all responses of ≥partial response occurring in the 45 mg/m2 selinexor plus 20 mg dexamethasone twice weekly cohort (ORR = 50%). Furthermore, 46% of all patients showed a reduction in MM markers from baseline. Based on these findings, we conclude that selinexor in combination with dexamethasone is active in heavily pretreated MM and propose a RP2D of 45 mg/m2 (80 mg) plus 20 mg dexamethasone given twice weekly. This trial was registered at clinicaltrials.gov as #NCT01607892. more...
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- 2018
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22. Safety and efficacy of selinexor in relapsed or refractory multiple myeloma and Waldenstrom macroglobulinemia
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Chen, Christine, Siegel, David, Gutierrez, Martin, Jacoby, Meagan, Hofmeister, Craig C., Gabrail, Nashat, Baz, Rachid, Mau-Sorensen, Morten, Berdeja, Jesus G., Savona, Michael, Savoie, Lynn, Trudel, Suzanne, Areethamsirikul, Nuchanan, Unger, T.J., Rashal, Tami, Hanke, Tim, Kauffman, Michael, Shacham, Sharon, and Reece, Donna more...
- Abstract
Novel therapies are needed for patients with relapsed or refractory multiple myeloma (MM). We conducted a multicenter, phase 1 study in advanced hematological malignancies to assess the safety, efficacy, and recommended phase 2 dose (RP2D) of oral selinexor, a selective inhibitor of the nuclear export protein XPO1. In the dose-escalation phase, 25 patients with heavily pretreated MM (22) or Waldenstrom macroglobulinemia (3) were administered selinexor (3-60 mg/m2) in 8 or 10 doses per 28-day cycle. In the dose-expansion phase, 59 patients with MM received selinexor at 45 or 60 mg/m2with 20 mg dexamethasone, twice weekly in 28-day cycles, or selinexor (40 or 60 mg flat dose) without corticosteroids in 21-day cycles. The most common nonhematologic adverse events (AEs) were nausea (75%), fatigue (70%), anorexia (64%), vomiting (43%), weight loss (32%), and diarrhea (32%), which were primarily grade 1 or 2. The most common grade 3 or 4 AEs were hematologic, particularly thrombocytopenia (45%). Single-agent selinexor showed modest efficacy with an objective response rate (ORR) of 4% and clinical benefit rate of 21%. In contrast, the addition of dexamethasone increased the ORR with all responses of ≥partial response occurring in the 45 mg/m2selinexor plus 20 mg dexamethasone twice weekly cohort (ORR = 50%). Furthermore, 46% of all patients showed a reduction in MM markers from baseline. Based on these findings, we conclude that selinexor in combination with dexamethasone is active in heavily pretreated MM and propose a RP2D of 45 mg/m2(80 mg) plus 20 mg dexamethasone given twice weekly. This trial was registered at clinicaltrials.govas #NCT01607892. more...
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- 2018
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23. First-in-Class, First-in-Human Phase I Study of Selinexor, a Selective Inhibitor of Nuclear Export, in Patients With Advanced Solid Tumors.
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Abdul Razak, Albiruni R., Mau-Soerensen, Morten, Gabrail, Nashat Y., Gerecitano, John F., Shields, Anthony F., Unger, Thaddeus J., Saint-Martin, Jean R., Carlson, Robert, Landesman, Yosef, McCauley, Dilara, Rashal, Tami, Lassen, Ulrik, Kim, Richard, Stayner, Lee-Anne, Mirza, Mansoor R., Kauffman, Michael, Shacham, Sharon, and Mahipal, Amit more...
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- 2016
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24. Selective inhibition of nuclear export with selinexor in patients with non-Hodgkin lymphoma
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Kuruvilla, John, Savona, Michael, Baz, Rachid, Mau-Sorensen, Paul Morten, Gabrail, Nashat, Garzon, Ramiro, Stone, Richard, Wang, Michael, Savoie, Lynn, Martin, Peter, Flinn, Ian, Jacoby, Meagan, Unger, Thaddeus J., Saint-Martin, Jean-Richard, Rashal, Tami, Friedlander, Sharon, Carlson, Robert, Kauffman, Michael, Shacham, Sharon, and Gutierrez, Martin more...
- Abstract
Patients with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) have a poor prognosis and limited treatment options. We evaluated selinexor, an orally bioavailable, first-in-class inhibitor of the nuclear export protein XPO1, in this phase 1 trial to assess safety and determine a recommended phase 2 dose (RP2D). Seventy-nine patients with various NHL histologies, including diffuse large B-cell lymphoma, Richter's transformation, mantle cell lymphoma, follicular lymphoma, and chronic lymphocytic leukemia, were enrolled. In the dose-escalation phase, patients received 3 to 80 mg/m2of selinexor in 3- or 4-week cycles and were assessed for toxicities, pharmacokinetics, and antitumor activity. In the dose-expansion phase, patients were treated with selinexor at 35 or 60 mg/m2. The most common grade 3 to 4 drug-related adverse events were thrombocytopenia (47%), neutropenia (32%), anemia (27%), leukopenia (16%), fatigue (11%), and hyponatremia (10%). Tumor biopsies showed decreases in cell-signaling pathways (Bcl-2, Bcl-6, c-Myc), reduced proliferation (Ki67), nuclear localization of XPO1 cargos (p53, PTEN), and increased apoptosis after treatment. Twenty-two (31%) of the 70 evaluable patients had an objective responses, including 4 complete responses and 18 partial responses, which were observed across a spectrum of NHL subtypes. A dose of 35 mg/m2(60 mg) was identified as the RP2D. These findings suggest that inhibition of XPO1 with oral selinexor at 35 mg/m2is a safe therapy with encouraging and durable anticancer activity in patients with R/R NHL. The trial was registered at www.clinicaltrials.govas #NCT01607892. more...
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- 2017
- Full Text
- View/download PDF
25. A phase 1 clinical trial of single-agent selinexor in acute myeloid leukemia
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Garzon, Ramiro, Savona, Michael, Baz, Rachid, Andreeff, Michael, Gabrail, Nashat, Gutierrez, Martin, Savoie, Lynn, Mau-Sorensen, Paul Morten, Wagner-Johnston, Nina, Yee, Karen, Unger, Thaddeus J., Saint-Martin, Jean-Richard, Carlson, Robert, Rashal, Tami, Kashyap, Trinayan, Klebanov, Boris, Shacham, Sharon, Kauffman, Michael, and Stone, Richard more...
- Abstract
Selinexor is a novel, first-in-class, selective inhibitor of nuclear export compound, which blocks exportin 1 (XPO1) function, leads to nuclear accumulation of tumor suppressor proteins, and induces cancer cell death. A phase 1 dose-escalation study was initiated to examine the safety and efficacy of selinexor in patients with advanced hematological malignancies. Ninety-five patients with relapsed or refractory acute myeloid leukemia (AML) were enrolled between January 2013 and June 2014 to receive 4, 8, or 10 doses of selinexor in a 21- or 28-day cycle. The most frequently reported adverse events (AEs) in patients with AML were grade 1 or 2 constitutional and gastrointestinal toxicities, which were generally manageable with supportive care. The only nonhematological grade 3/4 AE, occurring in >5% of the patient population, was fatigue (14%). There were no reported dose-limiting toxicities or evidence of cumulative toxicity. The recommended phase 2 dose was established at 60 mg (∼35 mg/m2) given twice weekly in a 4-week cycle based on the totality of safety and efficacy data. Overall, 14% of the 81 evaluable patients achieved an objective response (OR) and 31% percent showed ≥50% decrease in bone marrow blasts from baseline. Patients achieving an OR had a significant improvement in median progression-free survival (PFS) (5.1 vs 1.3 months; P= .008; hazard ratio [HR], 3.1) and overall survival (9.7 vs 2.7 months; P= .01; HR, 3.1) compared with nonresponders. These findings suggest that selinexor is safe as a monotherapy in patients with relapsed or refractory AML and have informed subsequent phase 2 clinical development. This trial was registered at www.clinicaltrials.govas #NCT01607892. more...
- Published
- 2017
- Full Text
- View/download PDF
26. Selective inhibition of nuclear export with selinexor in patients with non-Hodgkin lymphoma
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Kuruvilla, John, Savona, Michael, Baz, Rachid, Mau-Sorensen, Paul Morten, Gabrail, Nashat, Garzon, Ramiro, Stone, Richard, Wang, Michael, Savoie, Lynn, Martin, Peter, Flinn, Ian, Jacoby, Meagan, Unger, Thaddeus J., Saint-Martin, Jean-Richard, Rashal, Tami, Friedlander, Sharon, Carlson, Robert, Kauffman, Michael, Shacham, Sharon, and Gutierrez, Martin more...
- Abstract
Patients with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) have a poor prognosis and limited treatment options. We evaluated selinexor, an orally bioavailable, first-in-class inhibitor of the nuclear export protein XPO1, in this phase 1 trial to assess safety and determine a recommended phase 2 dose (RP2D). Seventy-nine patients with various NHL histologies, including diffuse large B-cell lymphoma, Richter’s transformation, mantle cell lymphoma, follicular lymphoma, and chronic lymphocytic leukemia, were enrolled. In the dose-escalation phase, patients received 3 to 80 mg/m2 of selinexor in 3- or 4-week cycles and were assessed for toxicities, pharmacokinetics, and antitumor activity. In the dose-expansion phase, patients were treated with selinexor at 35 or 60 mg/m2. The most common grade 3 to 4 drug-related adverse events were thrombocytopenia (47%), neutropenia (32%), anemia (27%), leukopenia (16%), fatigue (11%), and hyponatremia (10%). Tumor biopsies showed decreases in cell-signaling pathways (Bcl-2, Bcl-6, c-Myc), reduced proliferation (Ki67), nuclear localization of XPO1 cargos (p53, PTEN), and increased apoptosis after treatment. Twenty-two (31%) of the 70 evaluable patients had an objective responses, including 4 complete responses and 18 partial responses, which were observed across a spectrum of NHL subtypes. A dose of 35 mg/m2 (60 mg) was identified as the RP2D. These findings suggest that inhibition of XPO1 with oral selinexor at 35 mg/m2 is a safe therapy with encouraging and durable anticancer activity in patients with R/R NHL. The trial was registered at www.clinicaltrials.gov as #NCT01607892. more...
- Published
- 2017
- Full Text
- View/download PDF
27. A phase 1 clinical trial of single-agent selinexor in acute myeloid leukemia
- Author
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Garzon, Ramiro, Savona, Michael, Baz, Rachid, Andreeff, Michael, Gabrail, Nashat, Gutierrez, Martin, Savoie, Lynn, Mau-Sorensen, Paul Morten, Wagner-Johnston, Nina, Yee, Karen, Unger, Thaddeus J., Saint-Martin, Jean-Richard, Carlson, Robert, Rashal, Tami, Kashyap, Trinayan, Klebanov, Boris, Shacham, Sharon, Kauffman, Michael, and Stone, Richard more...
- Abstract
Selinexor is a novel, first-in-class, selective inhibitor of nuclear export compound, which blocks exportin 1 (XPO1) function, leads to nuclear accumulation of tumor suppressor proteins, and induces cancer cell death. A phase 1 dose-escalation study was initiated to examine the safety and efficacy of selinexor in patients with advanced hematological malignancies. Ninety-five patients with relapsed or refractory acute myeloid leukemia (AML) were enrolled between January 2013 and June 2014 to receive 4, 8, or 10 doses of selinexor in a 21- or 28-day cycle. The most frequently reported adverse events (AEs) in patients with AML were grade 1 or 2 constitutional and gastrointestinal toxicities, which were generally manageable with supportive care. The only nonhematological grade 3/4 AE, occurring in >5% of the patient population, was fatigue (14%). There were no reported dose-limiting toxicities or evidence of cumulative toxicity. The recommended phase 2 dose was established at 60 mg (∼35 mg/m2) given twice weekly in a 4-week cycle based on the totality of safety and efficacy data. Overall, 14% of the 81 evaluable patients achieved an objective response (OR) and 31% percent showed ≥50% decrease in bone marrow blasts from baseline. Patients achieving an OR had a significant improvement in median progression-free survival (PFS) (5.1 vs 1.3 months; P = .008; hazard ratio [HR], 3.1) and overall survival (9.7 vs 2.7 months; P = .01; HR, 3.1) compared with nonresponders. These findings suggest that selinexor is safe as a monotherapy in patients with relapsed or refractory AML and have informed subsequent phase 2 clinical development. This trial was registered at www.clinicaltrials.gov as #NCT01607892. more...
- Published
- 2017
- Full Text
- View/download PDF
28. Community-Based Phase IIIB Trial of Three UPFRONT Bortezomib-Based Myeloma Regimens.
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Niesvizky, Ruben, Flinn, Ian W., Rifkin, Robert, Gabrail, Nashat, Charu, Veena, Clowney, Billy, Essell, James, Gaffar, Yousuf, Warr, Thomas, Neuwirth, Rachel, Yanyan Zhu, Elliott, Jennifer, Esseltine, Dixie-Lee, Niculescu, Liviu, Reeves, James, and Zhu, Yanyan more...
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- 2015
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29. PRECEDENT: A Randomized Phase II Trial Comparing Vintafolide (EC145) and Pegylated Liposomal Doxorubicin (PLD) in Combination Versus PLD Alone in Patients With Platinum-Resistant Ovarian Cancer.
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Naumann, R. Wendel, Coleman, Robert L., Burger, Robert A., Sausville, Edward A., Kutarska, Elzbieta, Ghamande, Sharad A., Gabrail, Nashat Y., DePasquale, Stephen E., Nowara, Elzbieta, Gilbert, Lucy, Gersh, Robert H., Teneriello, Michael G., Harb, Wael A., Konstantinopoulos, Panagiotis A., Penson, Richard T., Symanowski, James T., Lovejoy, Chandra D., Leamon, Christopher P., Morgenstern, David E., and Messmann, Richard A. more...
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- 2013
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30. Randomized Open-Label Phase II Study of Decitabine in Patients With Low- or Intermediate-Risk Myelodysplastic Syndromes.
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Garcia-Manero, Guillermo, Jabbour, Elias, Borthakur, Gautam, Faderl, Stefan, Estrov, Zeev, Hui Yang, Maddipoti, Sirisha, Godley, Lucy A., Gabrail, Nashat, Berdeja, Jesus G., Nadeem, Ahmed, Kassalow, Laurent, and Kantarjian, Hagop more...
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- 2013
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31. TROPICS 1: A Phase III, Randomized, Double-blind, Placebo-controlled Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters.
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Gabrail, Nashat, Sandler, Eric, Charu, Veena, Anas, Nick, Lim, Eduardo, Blaney, Martha, Ashby, Mark, Gillespie, Barbara S., and Begelman, Susan M.
- Abstract
Purpose: To evaluate the efficacy and safety of the thrombolytic tenecteplase, a fibrin-specific recombinant tissue plasminogen activator, for restoring function to dysfunctional central venous catheters (CVCs). Materials and Methods: In this double-blind, placebo-controlled study, eligible patients with dysfunctional nonhemodialysis CVCs were randomly assigned to two treatment arms. In the first arm (TNK-TNK-PBO), patients received an initial dose of intraluminal tenecteplase (TNK) (up to 2 mg), a second dose of tenecteplase if indicated, and a third placebo (PBO) dose. In the PBO-TNK-TNK arm, placebo was instilled first followed by up to two doses of tenecteplase, if needed, for restoration of catheter function. After administration of each dose, CVC function was assessed at 15, 30, and 120 minutes. Results: There were 97 patients who received either TNK-TNK-PBO (n = 50) or PBO-TNK-TNK (n = 47). Within 120 minutes of initial study drug instillation, catheter function was restored to 30 patients (60%) in the TNK-TNK-PBO arm and 11 patients (23%) in the PBO-TNK-TNK arm, for a treatment difference of 37 percentage points (95% confidence interval 18–55; P = .0002). Cumulative restoration rates for CVC function increased to 87% after the second dose of tenecteplase in both study arms combined. Two patients developed a deep vein thrombosis (DVT) after exposure to tenecteplase; one DVT was considered to be drug related. No cases of intracranial hemorrhage, major bleeding, embolic events, catheter-related bloodstream infections, or catheter-related complications were reported. Conclusions: Tenecteplase was efficacious for restoration of catheter function in these study patients with dysfunctional CVCs. [ABSTRACT FROM AUTHOR] more...
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- 2010
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32. An open-label, single-arm, phase 2 (PX-171-004) study of single-agent carfilzomib in bortezomib-naive patients with relapsed and/or refractory multiple myeloma
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Vij, Ravi, Wang, Michael, Kaufman, Jonathan L., Lonial, Sagar, Jakubowiak, Andrzej J., Stewart, A. Keith, Kukreti, Vishal, Jagannath, Sundar, McDonagh, Kevin T., Alsina, Melissa, Bahlis, Nizar J., Reu, Frederic J., Gabrail, Nashat Y., Belch, Andrew, Matous, Jeffrey V., Lee, Peter, Rosen, Peter, Sebag, Michael, Vesole, David H., Kunkel, Lori A., Wear, Sandra M., Wong, Alvin F., Orlowski, Robert Z., and Siegel, David S. more...
- Abstract
Carfilzomib is a selective proteasome inhibitor that binds irreversibly to its target. In phase 1 studies, carfilzomib elicited promising responses and an acceptable toxicity profile in patients with relapsed and/or refractory multiple myeloma (R/R MM). In the present phase 2, multicenter, open-label study, 129 bortezomib-naive patients with R/R MM (median of 2 prior therapies) were separated into Cohort 1, scheduled to receive intravenous carfilzomib 20 mg/m2for all treatment cycles, and Cohort 2, scheduled to receive 20 mg/m2for cycle 1 and then 27 mg/m2for all subsequent cycles. The primary end point was an overall response rate (≥ partial response) of 42.4% in Cohort 1 and 52.2% in Cohort 2. The clinical benefit response (overall response rate + minimal response) was 59.3% and 64.2% in Cohorts 1 and 2, respectively. Median duration of response was 13.1 months and not reached, and median time to progression was 8.3 months and not reached, respectively. The most common treatment-emergent adverse events were fatigue (62.0%) and nausea (48.8%). Single-agent carfilzomib elicited a low incidence of peripheral neuropathy—17.1% overall (1 grade 3; no grade 4)—in these pretreated bortezomib-naive patients. The results of the present study support the use of carfilzomib in R/R MM patients. This trial is registered at www.clinicaltrials.govas NCT00530816. more...
- Published
- 2012
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33. An open-label, single-arm, phase 2 (PX-171-004) study of single-agent carfilzomib in bortezomib-naive patients with relapsed and/or refractory multiple myeloma
- Author
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Vij, Ravi, Wang, Michael, Kaufman, Jonathan L., Lonial, Sagar, Jakubowiak, Andrzej J., Stewart, A. Keith, Kukreti, Vishal, Jagannath, Sundar, McDonagh, Kevin T., Alsina, Melissa, Bahlis, Nizar J., Reu, Frederic J., Gabrail, Nashat Y., Belch, Andrew, Matous, Jeffrey V., Lee, Peter, Rosen, Peter, Sebag, Michael, Vesole, David H., Kunkel, Lori A., Wear, Sandra M., Wong, Alvin F., Orlowski, Robert Z., and Siegel, David S. more...
- Abstract
Carfilzomib is a selective proteasome inhibitor that binds irreversibly to its target. In phase 1 studies, carfilzomib elicited promising responses and an acceptable toxicity profile in patients with relapsed and/or refractory multiple myeloma (R/R MM). In the present phase 2, multicenter, open-label study, 129 bortezomib-naive patients with R/R MM (median of 2 prior therapies) were separated into Cohort 1, scheduled to receive intravenous carfilzomib 20 mg/m2 for all treatment cycles, and Cohort 2, scheduled to receive 20 mg/m2 for cycle 1 and then 27 mg/m2 for all subsequent cycles. The primary end point was an overall response rate (≥ partial response) of 42.4% in Cohort 1 and 52.2% in Cohort 2. The clinical benefit response (overall response rate + minimal response) was 59.3% and 64.2% in Cohorts 1 and 2, respectively. Median duration of response was 13.1 months and not reached, and median time to progression was 8.3 months and not reached, respectively. The most common treatment-emergent adverse events were fatigue (62.0%) and nausea (48.8%). Single-agent carfilzomib elicited a low incidence of peripheral neuropathy—17.1% overall (1 grade 3; no grade 4)—in these pretreated bortezomib-naive patients. The results of the present study support the use of carfilzomib in R/R MM patients. This trial is registered at www.clinicaltrials.gov as NCT00530816. more...
- Published
- 2012
- Full Text
- View/download PDF
34. IV iron sucrose for cancer and/or chemotherapy-induced anemia in patients treated with erythropoiesis-stimulating agents
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Anthony, Lowell B., Gabrail, Nashat Y., Ghazal, Hassan, Woytowitz, Donald V., Flam, Marshall S., Drelichman, Anibal, Loesch, David M., Niforos, Demi A., and Mangione, Antoinette
- Abstract
Intravenous (IV) iron is commonly administered with erythropoiesis-stimulating agents (ESAs) in patients with anemia associated with chronic kidney disease. Several studies have yielded positive results with the use of IV iron replacement in patients with cancer and/or chemotherapy-induced anemia (CCIA). To investigate whether IV iron sucrose is an effective and safe way to manage CCIA in patients treated with ESAs, the authors conducted a randomized, controlled trial of 375 patients with CCIA (hemoglobin [Hgb] level = 10 g/dL). Compared with ESAs alone, iron sucrose plus ESAs resulted in higher maximum Hgb levels, and Hgb level increases = 2 g/dL and = 3 g/dL were achieved in both prior ESA responders and nonresponders. Iron sucrose also resulted in a statistically significant improvement in Functional Assessment of Chronic Illness Therapy (FACIT) fatigue scores. Three serious but non-life-threatening iron sucrose-related adverse events were observed, including one case of significant, transient hypotension in a woman weighing 50 kg. The authors conclude that the combination of ESA therapy and IV iron sucrose (in individual doses of up to 500 mg) may prove to be an effective and safe way to increase Hgb levels and improve quality of life in this patient population regardless of the prior response to ESAs and iron indices. more...
- Published
- 2011
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35. Clinical Efficacy and Safety of Oral Decitabine/Cedazuridine in 133 Patients with Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)
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Savona, Michael R., McCloskey, James K., Griffiths, Elizabeth A., Yee, Karen W.L., Al-Kali, Aref, Zeidan, Amer M., Deeg, H. Joachim, Patel, Prapti A., Sabloff, Mitchell, Keating, Mary-Margaret, Dao, Kim-Hien, Zhu, Nancy, Gabrail, Nashat, Fazal, Salman, Maly, Joseph, Odenike, Olatoyosi, Kantarjian, Hagop M., DeZern, Amy E., O'Connell, Casey L., Roboz, Gail J., Busque, Lambert, Wells, Richard A., Amin, Harshad, Randhawa, Jasleen K., Leber, Brian, Hao, Yong, Keer, Harold N., Azab, Mohammad, and Garcia-Manero, Guillermo more...
- Abstract
Savona: BMS: Consultancy; AbbVie: Consultancy; Gilead: Consultancy; Karyopharm: Consultancy, Current equity holder in publicly-traded company; Ryvu: Consultancy; Boehringer Ingelheim: Patents & Royalties; Takeda: Consultancy, Research Funding; Incyte: Consultancy, Research Funding; Astex: Consultancy, Research Funding; Sunesis: Consultancy, Research Funding; TG Therapeutics: Consultancy, Research Funding. Griffiths:Celgene/BMS: Honoraria, Research Funding; Genentech Inc: Research Funding; Boston Biomedical: Honoraria; AbbVie Inc: Honoraria; Persimmune: Research Funding; Novartis: Honoraria, Research Funding; Alexion Pharmaceuticals: Honoraria, Research Funding; Astex Pharmceuticals: Research Funding. Zeidan:CCITLA: Other; Seattle Genetics: Consultancy, Honoraria; BeyondSpring: Consultancy, Honoraria; Taiho: Consultancy, Honoraria; Cardinal Health: Consultancy, Honoraria; Epizyme: Consultancy, Honoraria; Leukemia and Lymphoma Society: Other; Jazz: Consultancy, Honoraria; Trovagene: Consultancy, Honoraria, Research Funding; Ionis: Consultancy, Honoraria; Takeda: Consultancy, Honoraria, Research Funding; Astex: Research Funding; Daiichi Sankyo: Consultancy, Honoraria; Abbvie: Consultancy, Honoraria, Research Funding; Otsuka: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria, Research Funding; Acceleron: Consultancy, Honoraria; Novartis: Consultancy, Honoraria, Research Funding; Boehringer-Ingelheim: Consultancy, Honoraria, Research Funding; Celgene / BMS: Consultancy, Honoraria, Research Funding; Agios: Consultancy, Honoraria; ADC Therapeutics: Research Funding; Aprea: Research Funding; MedImmune/Astrazeneca: Research Funding; Cardiff Oncology: Consultancy, Honoraria, Other; Incyte: Consultancy, Honoraria, Research Funding; Astellas: Consultancy, Honoraria. Patel:DAVA Pharmaceuticals: Honoraria; France Foundation: Honoraria; Celgene: Consultancy, Speakers Bureau; Agios: Consultancy. Keating:Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Hoffman La Roche: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; Merck: Membership on an entity's Board of Directors or advisory committees; Sanofi: Membership on an entity's Board of Directors or advisory committees; Seattle Genetics: Consultancy; Servier: Membership on an entity's Board of Directors or advisory committees; Shire: Membership on an entity's Board of Directors or advisory committees; Taiho: Membership on an entity's Board of Directors or advisory committees. Dao:Astex Pharmaceuticals, Inc.: Current Employment. Fazal:Jansen: Speakers Bureau; Gilead/Kite: Consultancy, Speakers Bureau; Takeda: Consultancy, Speakers Bureau; Jazz Pharma: Consultancy, Speakers Bureau; Karyopham: Speakers Bureau; Celgene: Speakers Bureau; Glaxosmith Kline: Consultancy, Speakers Bureau; Incyte Corporation: Consultancy, Honoraria, Speakers Bureau; Agios: Consultancy, Speakers Bureau; Stemline: Consultancy, Speakers Bureau; Amgen: Consultancy, Speakers Bureau; Novartis: Consultancy, Speakers Bureau; BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Odenike:Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees; Astex Pharmaceuticals, NS Pharma, Gilead Sciences, Janssen Oncology, Oncotherapy, Agios, CTI/Baxalta, Aprea: Other: Institutional research funding; Astra Zeneca: Research Funding; Incyte: Other: Institutional research funding; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Impact Biomedicines: Consultancy, Membership on an entity's Board of Directors or advisory committees; AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding. Kantarjian:Abbvie: Honoraria, Research Funding; BioAscend: Honoraria; Delta Fly: Honoraria; Ascentage: Research Funding; Janssen: Honoraria; Novartis: Honoraria, Research Funding; Pfizer: Honoraria, Research Funding; Sanofi: Research Funding; Actinium: Honoraria, Membership on an entity's Board of Directors or advisory committees; Immunogen: Research Funding; Aptitute Health: Honoraria; BMS: Research Funding; Daiichi-Sankyo: Honoraria, Research Funding; Jazz: Research Funding; Oxford Biomedical: Honoraria; Amgen: Honoraria, Research Funding; Adaptive biotechnologies: Honoraria. DeZern:MEI: Consultancy; Celgene: Consultancy, Honoraria; Astex: Research Funding; Abbvie: Consultancy. Roboz:Novartis: Consultancy; Janssen: Consultancy; Celgene: Consultancy; Astex: Consultancy; Amphivena: Consultancy; Agios: Consultancy; Pfizer: Consultancy; Abbvie: Consultancy; Array BioPharma: Consultancy; Bayer: Consultancy; Celltrion: Consultancy; Eisai: Consultancy; Jazz: Consultancy; Roche/Genentech: Consultancy; Sandoz: Consultancy; Actinium: Consultancy; Argenx: Consultancy; Astellas: Consultancy; Daiichi Sankyo: Consultancy; AstraZeneca: Consultancy; Orsenix: Consultancy; Otsuka: Consultancy; Takeda: Consultancy; Trovagene: Consultancy; Cellectis: Research Funding; Jasper Therapeutics: Consultancy; Epizyme: Consultancy; Helsinn: Consultancy; MEI Pharma: Consultancy. Busque:Pfizer: Honoraria; BMS: Honoraria; Novartis: Honoraria. Wells:Alexion: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Leber:Pfizer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Otsuka Pharmaceutical: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda/Palladin: Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Treadwell: Honoraria, Membership on an entity's Board of Directors or advisory committees; Lundbeck: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Alexion: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Abbvie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; BMS/Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees. Hao:Astex Pharmaceuticals, Inc.: Current Employment. Keer:Astex Pharmaceuticals, Inc.: Current Employment. Azab:Astex Pharmaceuticals, Inc.: Current Employment. Garcia-Manero:Acceleron Pharmaceuticals: Consultancy, Honoraria; AbbVie: Honoraria, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; H3 Biomedicine: Research Funding; Genentech: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Astex Pharmaceuticals: Consultancy, Honoraria, Research Funding; Amphivena Therapeutics: Research Funding; Helsinn Therapeutics: Consultancy, Honoraria, Research Funding; Onconova: Research Funding; Merck: Research Funding; Jazz Pharmaceuticals: Consultancy; Celgene: Consultancy, Honoraria, Research Funding; Novartis: Research Funding. more...
- Published
- 2020
- Full Text
- View/download PDF
36. Clinical Efficacy and Safety of Oral Decitabine/Cedazuridine in 133 Patients with Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)
- Author
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Savona, Michael R., McCloskey, James K., Griffiths, Elizabeth A., Yee, Karen W.L., Al-Kali, Aref, Zeidan, Amer M., Deeg, H. Joachim, Patel, Prapti A., Sabloff, Mitchell, Keating, Mary-Margaret, Dao, Kim-Hien, Zhu, Nancy, Gabrail, Nashat, Fazal, Salman, Maly, Joseph, Odenike, Olatoyosi, Kantarjian, Hagop M., DeZern, Amy E., O'Connell, Casey L., Roboz, Gail J., Busque, Lambert, Wells, Richard A., Amin, Harshad, Randhawa, Jasleen K., Leber, Brian, Hao, Yong, Keer, Harold N., Azab, Mohammad, and Garcia-Manero, Guillermo more...
- Published
- 2020
- Full Text
- View/download PDF
37. Treatment of Chemotherapy-Induced Anemia in Breast Cancer: Results of a Randomized Controlled Trial of Darbepoetin Alfa 200 μg Every 2 Weeks Versus Epoetin Alfa 40,000 U Weekly
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Senecal, Frank M., Yee, Lorrin, Gabrail, Nashat, Charu, Veena, Tomita, Dianne, Rossi, Greg, and Schwartzberg, Lee
- Abstract
Current chemotherapy regimens for breast cancer result in high incidences of anemia, which can be treated with erythropoietic agents. The relative efficacy of darbepoetin alfa and epoetin alfa was explored in this phase II, open-label, randomized, multicenter trial in anemic patients with breast cancer receiving chemotherapy. more...
- Published
- 2005
- Full Text
- View/download PDF
38. Establishing the dosage equivalency of oxymorphone extended release and oxycodone controlled release in patients with cancer pain: a randomized controlled study
- Author
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Gabrail, Nashat Y., Dvergsten, Chris, and Ahdieh, Harry
- Abstract
SUMMARYObjective:To compare the analgesic efficacy and safety of oxymorphone extended release (ER) and oxycodone controlled release (CR) in patients with moderate to severe cancer pain.Research design and methods:This randomized, multicenter, double-blind, 2-period crossover study included adult outpatients (≥ 18 years of age) with moderate or severe cancer pain who were first titrated for 3–10 days with open-label oxymorphone or oxycodone to achieve a stable dose that provided adequate analgesia with tolerable adverse events and no requirement for more than 2 doses of rescue medication per day. The subsequent double-blind treatment phase was a 7- to 10-day period of oxycodone CR or oxymorphone ER treatment followed by crossing over to the alternate medication for another 7–10 days. During the treatment phase, up to 2 doses per day of morphine sulfate 15-mg tablets were allowed as rescue.Main outcomes and measures:Assessments included the Brief Pain Inventory, global evaluations, Karnofsky performance status, and clinical laboratory evaluations (serum chemistry profile, complete blood count, urinalysis). Efficacy variables were analyzed using a mixed-effects model with treatment, sequence, and period as fixed effects and subject as a random effect.Results:Forty-seven patients entered the titration/stabilization phase, 44 received at least 1 dose of study drug, 42 completed the first double-blind phase, and 40 completed the second double-blind phase. Mean pain intensity scores and other efficacy parameters were comparable for the 2 groups. The mean daily dosage of oxycodone CR (91.9 mg) was twice that of oxymorphone ER (45.9 mg), an equianalgesic dose ratio of 2:1. Rescue medication use was low in both groups (approximately 1 tablet of morphine sulfate 15 mg/day). No significant differences in opioid adverse events were observed between the groups.Conclusions:Adult patients with cancer who were taking oxycodone CR were readily converted to oxymorphone ER and required half the milligram dose to stabilize their pain. Within 72 h, most patients achieved a stable dose that provided adequate relief with similar opioid adverse events. more...
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- 2004
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39. Trial in Progress: Phase 1b Study of Lisaftoclax (APG-2575) As a Single Agent or Combined with Other Therapeutic Agents in Patients with Relapsed and/or Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (R/R CLL/SLL)
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Davids, Matthew S., Siddiqi, Tanya, Chanan-Khan, Asher, Skarbnik, Alan, Winter, Allison M., Pagel, John M., Smith, Carrie, Gabrail, Nashat, Perekhrestenko, Tetiana, Pylypenko, Halyna, Kyselova, Olena, Karpenko, Olena, Popovska, Tetiana, Kriachok, Iryna, Usenko, Hanna, Proidakov, Andrew, Ivanov, Vladimir, Lysa, Tamila, Borisenkova, Elena, Bakirov, Bulat, Lukavetsky, Les, Uspenskaya, Olga, Konstantinova, Tatiana S., Samoylova, Olga S., Chen, Zi, Huang, Bo, Li, Mingyu, Ahmad, Mohammad, Mudenda, Boyd, Yang, Dajun, and Zhai, Yifan more...
- Abstract
Background: BCL-2 inhibition with venetoclax has proved to be highly effective treatment for patients with CLL. However, when administered to patients with CLL who have a high tumor burden, venetoclax is associated with an elevated risk of tumor lysis syndrome (TLS). Because of this risk, venetoclax is initiated with a gradual, 5-week dose ramp-up, requiring close laboratory monitoring over an extended period. Lisaftoclax (APG-2575) is a novel, potent, selective BCL-2 inhibitor under clinical development for hematologic malignancies (HMs). Preliminary data in 18 patients with CLL treated in a first-in-human study suggested the feasibility of an abbreviated ramp-up of lisaftoclax that might also result in a lower incidence of neutropenia (Ailawadhi et al, J Clin Oncol 39, 2021; abstr 7502). more...
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- 2021
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40. A Multi-Center, Phase 1b Study to Assess the Safety, Pharmacokinetics and Efficacy of Subcutaneous Isatuximab Plus Pomalidomide and Dexamethasone, in Patients with Relapsed/Refractory Multiple Myeloma
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Moreau, Philippe, Parmar, Gurdeep, Prince, Miles, Ocio, Enrique, Karanes, Chatchada, Madan, Sumit, Oriol, Albert, Bories, Pierre, Delforge, Michel, Gabrail, Nashat, Semiond, Dorothee, Jia, Nan, Macé, Sandrine, Suzan, Florence, van de Velde, Helgi, and Quach, Hang more...
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Introduction: Intravenous (IV) isatuximab (Isa) + pomalidomide and dexamethasone (Pd) is an approved regimen for the treatment of adults with relapsed/refractory multiple myeloma (RRMM). Subcutaneous (SC) drug delivery would optimize convenience of administration. more...
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- 2021
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41. Efficacy of Oral Decitabine/Cedazuridine (ASTX727) in the CMML Subgroup from the Ascertain Phase 3 Study
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Savona, Michael R., McCloskey, James K, Griffiths, Elizabeth A., Yee, Karen, Zeidan, Amer M., Al-Kali, Aref, Deeg, H. Joachim, Patel, Prapti, Sabloff, Mitchell, Keating, Mary-Margaret, Dao, Kim-Hien, Zhu, Nancy, Gabrail, Nashat, Fazal, Salman, Maly, Joseph, Odenike, Olatoyosi, Kantarjian, Hagop, DeZern, Amy E., O'Connell, Casey L., Roboz, Gail J., Busque, Lambert, Wells, Richard A., Amin, Harshad, Randhawa, Jasleen K., Leber, Brian, Hao, Yong, Keer, Harold N., Azab, Mohammad, and Garcia-Manero, Guillermo more...
- Abstract
Abstract text:
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- 2021
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42. Oral Decitabine/Cedazuridine in Patients with Lower Risk Myelodysplastic Syndrome: A Longer-Term Follow-up of from the Ascertain Study
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Garcia-Manero, Guillermo, McCloskey, James K, Griffiths, Elizabeth A., Yee, Karen, Zeidan, Amer M., Al-Kali, Aref, Deeg, H. Joachim, Patel, Prapti, Sabloff, Mitchell, Keating, Mary-Margaret, Dao, Kim-Hien, Zhu, Nancy, Gabrail, Nashat Y., Fazal, Salman, Maly, Joseph, Odenike, Olatoyosi, Kantarjian, Hagop, DeZern, Amy E., O'Connell, Casey L., Roboz, Gail J., Busque, Lambert, Wells, Richard A., Amin, Harshad, Randhawa, Jasleen K., Leber, Brian, Hao, Yong, Keer, Harold N., Azab, Mohammad, and Savona, Michael R. more...
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- 2021
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43. Efficacy of Oral Decitabine/Cedazuridine (ASTX727) in the CMML Subgroup from the Ascertain Phase 3 Study
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Savona, Michael R., McCloskey, James K, Griffiths, Elizabeth A., Yee, Karen, Zeidan, Amer M., Al-Kali, Aref, Deeg, H. Joachim, Patel, Prapti, Sabloff, Mitchell, Keating, Mary-Margaret, Dao, Kim-Hien, Zhu, Nancy, Gabrail, Nashat, Fazal, Salman, Maly, Joseph, Odenike, Olatoyosi, Kantarjian, Hagop, DeZern, Amy E., O'Connell, Casey L., Roboz, Gail J., Busque, Lambert, Wells, Richard A., Amin, Harshad, Randhawa, Jasleen K., Leber, Brian, Hao, Yong, Keer, Harold N., Azab, Mohammad, and Garcia-Manero, Guillermo more...
- Abstract
Savona: Geron: Consultancy, Membership on an entity's Board of Directors or advisory committees; CTI: Consultancy, Membership on an entity's Board of Directors or advisory committees; Karyopharm: Consultancy, Current equity holder in publicly-traded company, Membership on an entity's Board of Directors or advisory committees; BMS-Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees; NOVARTIS: Consultancy, Membership on an entity's Board of Directors or advisory committees; Ryvu: Consultancy, Membership on an entity's Board of Directors or advisory committees; Sierra Oncology: Consultancy, Membership on an entity's Board of Directors or advisory committees; Taiho: Consultancy, Membership on an entity's Board of Directors or advisory committees; TG Therapeutics: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; ALX Oncology: Research Funding; Astex: Research Funding; Incyte: Research Funding. McCloskey: Pfizer: Consultancy; Takeda: Consultancy, Speakers Bureau; Incyte: Speakers Bureau; Novartis: Consultancy; COTA: Other: Equity Ownership; BMS: Honoraria, Speakers Bureau; Amgen: Speakers Bureau; Jazz: Consultancy, Speakers Bureau. Griffiths: Boston Biomedical: Consultancy; Celgene/Bristol-Myers Squibb: Consultancy, Honoraria, Research Funding; Abbvie: Consultancy, Honoraria; Taiho Oncology: Consultancy, Honoraria; Genentech: Research Funding; Astex Pharmaceuticals: Honoraria, Research Funding; Takeda Oncology: Consultancy, Honoraria; Novartis: Honoraria; Apellis Pharmaceuticals: Research Funding; Alexion Pharmaceuticals: Consultancy, Research Funding. Yee: Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Forma Therapeutics: Research Funding; Geron: Research Funding; Shattuck Labs: Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb/Celgene: Membership on an entity's Board of Directors or advisory committees; F. Hoffmann La Roche: Membership on an entity's Board of Directors or advisory committees, Research Funding; AbbVie: Honoraria; Janssen: Research Funding; Onconova: Research Funding; Genentech: Research Funding; Otsuka: Membership on an entity's Board of Directors or advisory committees; MedImmune: Research Funding; Jazz: Research Funding; Astex: Membership on an entity's Board of Directors or advisory committees, Research Funding; Tolero: Research Funding; Takeda: Membership on an entity's Board of Directors or advisory committees; TaiHo: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees; Paladin: Membership on an entity's Board of Directors or advisory committees. Zeidan: BeyondSpring: Consultancy; Janssen: Consultancy; Boehringer Ingelheim: Consultancy, Research Funding; BioCryst: Other: Clinical Trial Committees; AstraZeneca: Consultancy; Pfizer: Other: Travel support, Research Funding; Kura: Consultancy, Other: Clinical Trial Committees; Incyte: Consultancy, Research Funding; Ionis: Consultancy; Daiichi Sankyo: Consultancy; Epizyme: Consultancy; Novartis: Consultancy, Other: Clinical Trial Committees, Travel support, Research Funding; Loxo Oncology: Consultancy, Other: Clinical Trial Committees; Genentech: Consultancy; Geron: Other: Clinical Trial Committees; Cardiff Oncology: Consultancy, Other: Travel support, Research Funding; BMS: Consultancy, Other: Clinical Trial Committees, Research Funding; Gilead: Consultancy, Other: Clinical Trial Committees; Aprea: Consultancy, Research Funding; Astellas: Consultancy; Astex: Research Funding; Jazz: Consultancy; Jasper: Consultancy; Amgen: Consultancy, Research Funding; Agios: Consultancy; ADC Therapeutics: Research Funding; Acceleron: Consultancy, Research Funding; AbbVie: Consultancy, Other: Clinical Trial Committees, Research Funding. Al-Kali: Novartis: Research Funding; Astex: Other: Research support to institution. Patel: Agios: Membership on an entity's Board of Directors or advisory committees; Celgene-BMS: Membership on an entity's Board of Directors or advisory committees; PVI: Honoraria. Sabloff: Takeda: Membership on an entity's Board of Directors or advisory committees; BMS: Membership on an entity's Board of Directors or advisory committees; Astellas: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees; TaiHo: Membership on an entity's Board of Directors or advisory committees; Jaxx: Membership on an entity's Board of Directors or advisory committees; Abbvie: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees; ROCHE: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees. Dao: Astex Pharmaceuticals, Inc.: Current Employment. Fazal: Janssen Oncology: Consultancy, Honoraria, Speakers Bureau; Taiho Pharmaceuticals: Consultancy, Honoraria, Speakers Bureau; Gilead Sciences: Consultancy, Honoraria, Speakers Bureau; Novartis: Consultancy, Honoraria, Speakers Bureau; Agios: Consultancy, Honoraria, Speakers Bureau; Sanofi Genzyme: Consultancy, Honoraria, Speakers Bureau; Takeda: Consultancy, Honoraria, Speakers Bureau; Glaxo Smith Kline: Consultancy, Honoraria, Speakers Bureau; AMGEN: Consultancy, Honoraria, Speakers Bureau; Incyte: Consultancy, Honoraria, Speakers Bureau; Jazz Pharmaceuticals: Consultancy, Honoraria, Speakers Bureau; Bristol Myers Squibb: Consultancy, Honoraria, Speakers Bureau; Stemline Therapeutics: Consultancy, Honoraria, Speakers Bureau; Karyopharm Pharmaceuticals: Consultancy, Honoraria, Speakers Bureau. Odenike: Celgene, Incyte, AstraZeneca, Astex, NS Pharma, AbbVie, Gilead, Janssen, Oncotherapy, Agios, CTI/Baxalta, Aprea: Research Funding; AbbVie, Celgene, Impact Biomedicines, Novartis, Taiho Oncology, Takeda: Consultancy. Kantarjian: Ipsen Pharmaceuticals: Honoraria; Astra Zeneca: Honoraria; Astellas Health: Honoraria; Aptitude Health: Honoraria; Pfizer: Honoraria, Research Funding; Novartis: Honoraria, Research Funding; Jazz: Research Funding; Immunogen: Research Funding; Daiichi-Sankyo: Research Funding; BMS: Research Funding; Ascentage: Research Funding; Amgen: Honoraria, Research Funding; AbbVie: Honoraria, Research Funding; KAHR Medical Ltd: Honoraria; NOVA Research: Honoraria; Precision Biosciences: Honoraria; Taiho Pharmaceutical Canada: Honoraria. DeZern: Bristol-Myers Squibb: Consultancy, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees; Taiho: Consultancy, Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees. Roboz: Janssen: Research Funding; AbbVie: Consultancy; Actinium: Consultancy; Agios: Consultancy; Amgen: Consultancy; Astex: Consultancy; Astellas: Consultancy; AstraZeneca: Consultancy; Bayer: Consultancy; Blueprint Medicines: Consultancy; Bristol Myers Squibb: Consultancy; Celgene: Consultancy; Daiichi Sankyo: Consultancy; Glaxo SmithKline: Consultancy; Helsinn: Consultancy; Janssen: Consultancy; Jasper Therapeutics: Consultancy; Jazz: Consultancy; MEI Pharma - IDMC Chair: Consultancy; Mesoblast: Consultancy; Novartis: Consultancy; Otsuka: Consultancy; Pfizer: Consultancy; Roche/Genentech: Consultancy. Busque: Novartis: Consultancy. Leber: Novartis: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Pfizer: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; BMS: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Abbvie: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; AMGEN: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; TaiHo: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Otsuka: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Astellas: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Jazz: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Hao: Astex Pharmaceuticals, Inc.: Current Employment. Keer: Astex Pharmaceuticals, Inc.: Current Employment. Azab: Astex Pharmaceuticals, Inc.: Membership on an entity's Board of Directors or advisory committees. more...
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- 2021
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44. Oral Decitabine/Cedazuridine in Patients with Lower Risk Myelodysplastic Syndrome: A Longer-Term Follow-up of from the Ascertain Study
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Garcia-Manero, Guillermo, McCloskey, James K, Griffiths, Elizabeth A., Yee, Karen, Zeidan, Amer M., Al-Kali, Aref, Deeg, H. Joachim, Patel, Prapti, Sabloff, Mitchell, Keating, Mary-Margaret, Dao, Kim-Hien, Zhu, Nancy, Gabrail, Nashat Y., Fazal, Salman, Maly, Joseph, Odenike, Olatoyosi, Kantarjian, Hagop, DeZern, Amy E., O'Connell, Casey L., Roboz, Gail J., Busque, Lambert, Wells, Richard A., Amin, Harshad, Randhawa, Jasleen K., Leber, Brian, Hao, Yong, Keer, Harold N., Azab, Mohammad, and Savona, Michael R. more...
- Abstract
McCloskey: Pfizer: Consultancy; Jazz: Consultancy, Speakers Bureau; COTA: Other: Equity Ownership; Incyte: Speakers Bureau; Takeda: Consultancy, Speakers Bureau; Novartis: Consultancy; BMS: Honoraria, Speakers Bureau; Amgen: Speakers Bureau. Griffiths: Alexion Pharmaceuticals: Consultancy, Research Funding; Abbvie: Consultancy, Honoraria; Taiho Oncology: Consultancy, Honoraria; Genentech: Research Funding; Novartis: Honoraria; Takeda Oncology: Consultancy, Honoraria; Astex Pharmaceuticals: Honoraria, Research Funding; Celgene/Bristol-Myers Squibb: Consultancy, Honoraria, Research Funding; Apellis Pharmaceuticals: Research Funding; Boston Biomedical: Consultancy. Yee: Paladin: Membership on an entity's Board of Directors or advisory committees; TaiHo: Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Genentech: Research Funding; Geron: Research Funding; Janssen: Research Funding; Jazz: Research Funding; MedImmune: Research Funding; Onconova: Research Funding; Tolero: Research Funding; AbbVie: Honoraria; Bristol-Myers Squibb/Celgene: Membership on an entity's Board of Directors or advisory committees; Otsuka: Membership on an entity's Board of Directors or advisory committees; Shattuck Labs: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees; F. Hoffmann La Roche: Membership on an entity's Board of Directors or advisory committees, Research Funding; Forma Therapeutics: Research Funding; Astex: Membership on an entity's Board of Directors or advisory committees, Research Funding. Zeidan: Novartis: Consultancy, Other: Clinical Trial Committees, Travel support, Research Funding; Genentech: Consultancy; Ionis: Consultancy; Astellas: Consultancy; Epizyme: Consultancy; AbbVie: Consultancy, Other: Clinical Trial Committees, Research Funding; Jasper: Consultancy; Cardiff Oncology: Consultancy, Other: Travel support, Research Funding; BeyondSpring: Consultancy; Loxo Oncology: Consultancy, Other: Clinical Trial Committees; Janssen: Consultancy; Acceleron: Consultancy, Research Funding; AstraZeneca: Consultancy; Kura: Consultancy, Other: Clinical Trial Committees; Gilead: Consultancy, Other: Clinical Trial Committees; Agios: Consultancy; Daiichi Sankyo: Consultancy; Boehringer Ingelheim: Consultancy, Research Funding; Geron: Other: Clinical Trial Committees; BMS: Consultancy, Other: Clinical Trial Committees, Research Funding; BioCryst: Other: Clinical Trial Committees; Pfizer: Other: Travel support, Research Funding; Aprea: Consultancy, Research Funding; ADC Therapeutics: Research Funding; Jazz: Consultancy; Incyte: Consultancy, Research Funding; Amgen: Consultancy, Research Funding; Astex: Research Funding. Al-Kali: Astex: Other: Research support to institution; Novartis: Research Funding. Patel: Celgene-BMS: Membership on an entity's Board of Directors or advisory committees; PVI: Honoraria; Agios: Membership on an entity's Board of Directors or advisory committees. Sabloff: Pfizer: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees; Astellas: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees; ROCHE: Membership on an entity's Board of Directors or advisory committees; TaiHo: Membership on an entity's Board of Directors or advisory committees; Jaxx: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees; BMS: Membership on an entity's Board of Directors or advisory committees; Abbvie: Membership on an entity's Board of Directors or advisory committees. Dao: Astex Pharmaceuticals, Inc.: Current Employment. Fazal: Taiho Pharmaceuticals: Consultancy, Honoraria, Speakers Bureau; Stemline Therapeutics: Consultancy, Honoraria, Speakers Bureau; Sanofi Genzyme: Consultancy, Honoraria, Speakers Bureau; Novartis: Consultancy, Honoraria, Speakers Bureau; Karyopharm Pharmaceuticals: Consultancy, Honoraria, Speakers Bureau; Jazz Pharmaceuticals: Consultancy, Honoraria, Speakers Bureau; Janssen Oncology: Consultancy, Honoraria, Speakers Bureau; Incyte: Consultancy, Honoraria, Speakers Bureau; Glaxo Smith Kline: Consultancy, Honoraria, Speakers Bureau; Gilead Sciences: Consultancy, Honoraria, Speakers Bureau; Bristol Myers Squibb: Consultancy, Honoraria, Speakers Bureau; AMGEN: Consultancy, Honoraria, Speakers Bureau; Agios: Consultancy, Honoraria, Speakers Bureau; Takeda: Consultancy, Honoraria, Speakers Bureau. Odenike: AbbVie, Celgene, Impact Biomedicines, Novartis, Taiho Oncology, Takeda: Consultancy; Celgene, Incyte, AstraZeneca, Astex, NS Pharma, AbbVie, Gilead, Janssen, Oncotherapy, Agios, CTI/Baxalta, Aprea: Research Funding. Kantarjian: AbbVie: Honoraria, Research Funding; Novartis: Honoraria, Research Funding; Ascentage: Research Funding; Pfizer: Honoraria, Research Funding; BMS: Research Funding; Daiichi-Sankyo: Research Funding; Amgen: Honoraria, Research Funding; Ipsen Pharmaceuticals: Honoraria; Jazz: Research Funding; Astellas Health: Honoraria; Immunogen: Research Funding; Astra Zeneca: Honoraria; Aptitude Health: Honoraria; KAHR Medical Ltd: Honoraria; NOVA Research: Honoraria; Precision Biosciences: Honoraria; Taiho Pharmaceutical Canada: Honoraria. DeZern: Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees; Taiho: Consultancy, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Consultancy, Membership on an entity's Board of Directors or advisory committees. Roboz: Novartis: Consultancy; Mesoblast: Consultancy; Jasper Therapeutics: Consultancy; Jazz: Consultancy; MEI Pharma - IDMC Chair: Consultancy; Daiichi Sankyo: Consultancy; Otsuka: Consultancy; Bristol Myers Squibb: Consultancy; Blueprint Medicines: Consultancy; Bayer: Consultancy; AstraZeneca: Consultancy; Astellas: Consultancy; Astex: Consultancy; Amgen: Consultancy; Agios: Consultancy; Actinium: Consultancy; AbbVie: Consultancy; Janssen: Research Funding; Celgene: Consultancy; Glaxo SmithKline: Consultancy; Helsinn: Consultancy; Janssen: Consultancy; Pfizer: Consultancy; Roche/Genentech: Consultancy. Busque: Novartis: Consultancy. Leber: Astellas: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Otsuka: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celgene: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; TaiHo: Honoraria, Membership on an entity's Board of Directors or advisory committees; AMGEN: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Abbvie: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; BMS: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Pfizer: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Novartis: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Jazz: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Hao: Astex Pharmaceuticals, Inc.: Current Employment. Keer: Astex Pharmaceuticals, Inc.: Current Employment. Azab: Astex Pharmaceuticals, Inc.: Membership on an entity's Board of Directors or advisory committees. Savona: Geron: Consultancy, Membership on an entity's Board of Directors or advisory committees; Karyopharm: Consultancy, Current equity holder in publicly-traded company, Membership on an entity's Board of Directors or advisory committees; CTI: Consultancy, Membership on an entity's Board of Directors or advisory committees; BMS-Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees; NOVARTIS: Consultancy, Membership on an entity's Board of Directors or advisory committees; Ryvu: Consultancy, Membership on an entity's Board of Directors or advisory committees; Sierra Oncology: Consultancy, Membership on an entity's Board of Directors or advisory committees; Taiho: Consultancy, Membership on an entity's Board of Directors or advisory committees; TG Therapeutics: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; ALX Oncology: Research Funding; Astex: Research Funding; Incyte: Research Funding. more...
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- 2021
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45. Trial in Progress: Phase 1b Study of Lisaftoclax (APG-2575) As a Single Agent or Combined with Other Therapeutic Agents in Patients with Relapsed and/or Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (R/R CLL/SLL)
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Davids, Matthew S., Siddiqi, Tanya, Chanan-Khan, Asher, Skarbnik, Alan, Winter, Allison M., Pagel, John M., Smith, Carrie, Gabrail, Nashat, Perekhrestenko, Tetiana, Pylypenko, Halyna, Kyselova, Olena, Karpenko, Olena, Popovska, Tetiana, Kriachok, Iryna, Usenko, Hanna, Proidakov, Andrew, Ivanov, Vladimir, Lysa, Tamila, Borisenkova, Elena, Bakirov, Bulat, Lukavetsky, Les, Uspenskaya, Olga, Konstantinova, Tatiana S., Samoylova, Olga S., Chen, Zi, Huang, Bo, Li, Mingyu, Ahmad, Mohammad, Mudenda, Boyd, Yang, Dajun, and Zhai, Yifan more...
- Abstract
Davids: Ascentage Pharma: Consultancy, Research Funding; Astra-Zeneca: Consultancy, Research Funding; BMS: Consultancy, Research Funding; Genentech: Consultancy, Research Funding; MEI Pharma: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; Pharmacyclics: Consultancy, Research Funding; TG Therapeutics: Consultancy, Research Funding; Verastem: Consultancy, Research Funding; Surface Oncology: Research Funding; AbbVie: Consultancy; Adaptive Biotechnologies: Consultancy; BeiGene: Consultancy; Celgene: Consultancy; Eli Lilly and Company: Consultancy; Janssen: Consultancy; MEI Pharma: Consultancy; Merck: Consultancy; Research to Practice: Consultancy; Takeda: Consultancy. Siddiqi: Kite Pharma: Membership on an entity's Board of Directors or advisory committees; Juno therapeutics: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees; BMS: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Abbvie: Membership on an entity's Board of Directors or advisory committees; AstraZeneca: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; BeiGene: Other: DSM Member, Speakers Bureau; PCYC: Speakers Bureau; Jannsen: Speakers Bureau; Dava Oncology: Honoraria; ResearchToPractice: Honoraria. Pagel: Gilead: Consultancy; AstraZeneca: Consultancy; BeiGene: Consultancy; Incyte/MorphoSys: Consultancy; Epizyme: Consultancy; Kite, a Gilead Company: Consultancy; Actinium Pharmaceuticals: Consultancy; MEI Pharma: Consultancy; Pharmacyclics/AbbVie: Consultancy. Pylypenko: Communal nonprofit enterprise "Cherkasy regional oncology dispensary of Cherkasy oblast council: Current Employment. Kriachok: Takeda, Roche, Abbivie, Janssen, MSD: Consultancy; Takeda, Roche, Abbvie, Janssen, MSD, Pfizer: Honoraria, Speakers Bureau. Usenko: Abbvie: Honoraria; Acerta: Honoraria; Ascentage: Honoraria; AstraZeneca: Honoraria; Celgene: Honoraria; Il Yang: Honoraria; Janssen: Honoraria; Karyopharm: Honoraria; Oncopeptides: Honoraria; Rigel: Honoraria; Takeda: Honoraria; UCB: Honoraria. Chen: Ascentage Pharma (Suzhou) Co., Ltd: Current Employment, Current equity holder in publicly-traded company. Huang: Ascentage Pharma (Suzhou) Co., Ltd.: Current Employment, Current equity holder in publicly-traded company. Li: Ascentage Pharma (Suzhou) Co., Ltd.: Current Employment, Current equity holder in publicly-traded company. Ahmad: Ascentage Pharma Group Inc.: Current Employment, Current equity holder in publicly-traded company. Mudenda: Ascentage Pharma Group Inc.: Current Employment, Current equity holder in publicly-traded company. Yang: Ascentage Pharma (Suzhou) Co., Ltd: Current Employment, Current equity holder in publicly-traded company, Other: Leadership and other ownership interests, Patents & Royalties, Research Funding. Zhai: Ascentage Pharma (Suzhou) Co., Ltd.: Current Employment, Current equity holder in publicly-traded company, Other: Leadership and other ownership interests, Patents & Royalties, Research Funding; Ascentage Pharma Group Inc.: Current Employment, Current equity holder in publicly-traded company, Other: Leadership and other ownership interests, Patents & Royalties, Research Funding. more...
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- 2021
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46. A Multi-Center, Phase 1b Study to Assess the Safety, Pharmacokinetics and Efficacy of Subcutaneous Isatuximab Plus Pomalidomide and Dexamethasone, in Patients with Relapsed/Refractory Multiple Myeloma
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Moreau, Philippe, Parmar, Gurdeep, Prince, Miles, Ocio, Enrique, Karanes, Chatchada, Madan, Sumit, Oriol, Albert, Bories, Pierre, Delforge, Michel, Gabrail, Nashat, Semiond, Dorothee, Jia, Nan, Macé, Sandrine, Suzan, Florence, van de Velde, Helgi, and Quach, Hang more...
- Abstract
Moreau: Amgen: Honoraria; Oncopeptides: Honoraria; Janssen: Honoraria; Abbvie: Honoraria; Sanofi: Honoraria; Celgene BMS: Honoraria. Prince: Sanofi: Research Funding; Takeda: Consultancy, Honoraria, Research Funding; Celgene: Consultancy, Honoraria; Janssen China R&D: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Amgen: Consultancy, Honoraria. Ocio: MSD: Honoraria; Karyopharm: Consultancy; Sanofi: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Bristol-Myers Squibb/Celgene: Consultancy, Honoraria; Janssen: Consultancy, Honoraria, Speakers Bureau; Takeda: Consultancy, Honoraria, Speakers Bureau; Oncopeptides: Consultancy, Honoraria; Pfizer: Consultancy; Secura-Bio: Consultancy. Madan: GSK: Consultancy, Speakers Bureau; Sanofi: Consultancy, Research Funding; BMS: Consultancy, Speakers Bureau; Janssen: Consultancy, Speakers Bureau; Takeda: Speakers Bureau; Karyopharm: Consultancy, Research Funding; Amgen: Consultancy, Speakers Bureau. Oriol: Sanofi: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Oncopeptides: Consultancy, Membership on an entity's Board of Directors or advisory committees; GSK: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Karyopharm: Consultancy, Membership on an entity's Board of Directors or advisory committees; BMS/Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Bories: Gilead: Consultancy; Celgene: Consultancy; Abbvie: Consultancy; Novartis: Honoraria; BMS: Honoraria. Delforge: Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Bristol Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees. Semiond: Sanofi: Current Employment, Other: may hold shares and/ or stock options in the company. Jia: Sanofi: Current Employment, Other: may hold shares and/ or stock options in the company. Macé: Sanofi: Current Employment, Other: may hold shares and/ or stock options in the company. Suzan: Sanofi: Current Employment, Other: may hold shares and/ or stock options in the company. van de Velde: Sanofi: Current Employment, Other: may hold shares and/ or stock options in the company. Quach: Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees; Bristol Myers Squibb: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; GlaxoSmithKline: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Antengene: Consultancy, Membership on an entity's Board of Directors or advisory committees; CSL: Consultancy, Membership on an entity's Board of Directors or advisory committees; Janssen/Cilag: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Sanofi: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Karyopharm: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding.Isatuximab (Isa) in combination with pomalidomide and dexamethasone (Pd) is an approved regimen for an intravenous (IV) administration. This trial assesses the safety, pharmacokinetics and efficacy of subcutaneous (SC) administration of Isa-Pd. more...
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- 2021
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47. A Randomized, Open-Label, Multicenter, Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of KRT-232 Compared with Ruxolitinib in Patients with Phlebotomy-Dependent Polycythemia Vera
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Gotlib, Jason, Gabrail, Nashat, O'Connell, Casey L., Garcia-Delgado, Regina, Sbardellati, Timothy, Rothbaum, Wayne M., McGreivy, Jesse, Harrison, Claire N, and Kiladjian, Jean-Jacques
- Abstract
Gotlib: Deceiphera: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Gilead: Membership on an entity's Board of Directors or advisory committees, Research Funding; Seattle Genetics: Research Funding; Pharmacyclics: Research Funding; Promedior: Research Funding; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Blueprint Medicines: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Allakos: Honoraria, Membership on an entity's Board of Directors or advisory committees; Incyte: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. O'Connell:Pfizer: Membership on an entity's Board of Directors or advisory committees; Astex: Membership on an entity's Board of Directors or advisory committees, Research Funding; Shionogi: Membership on an entity's Board of Directors or advisory committees; BMS: Membership on an entity's Board of Directors or advisory committees; Genentech: Research Funding. Garcia-Delgado:Celgene: Speakers Bureau; Novartis: Consultancy, Speakers Bureau; Hospital Virgen De La Victoria Malaga: Employment. Sbardellati:Kartos Therapeutics: Employment, Equity Ownership. Rothbaum:Kartos Therapeutics: Employment, Patents & Royalties: Pending; Quogue Bioventures LLC: Equity Ownership, Membership on an entity's Board of Directors or advisory committees. McGreivy:Kartos Therapeutics: Employment, Equity Ownership, Membership on an entity's Board of Directors or advisory committees. Harrison:Janssen: Speakers Bureau; Gilead: Speakers Bureau; CTI: Speakers Bureau; Roche: Honoraria; Sierra Oncology: Honoraria; AOP: Honoraria; Novartis: Honoraria, Research Funding, Speakers Bureau; Celgene: Honoraria, Speakers Bureau; Promedior: Honoraria; Shire: Speakers Bureau; Incyte: Speakers Bureau. Kiladjian:AOP Orphan: Honoraria, Research Funding; Novartis: Honoraria, Research Funding; Celgene: Consultancy.Yes, KRT-232 is an investigational small molecule MDM2 inhibitor. This trial-in-progress abstract describes a registered clinical trial that will evaluate the safety and efficacy of KRT-232 for patients with polycythemia vera. more...
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- 2019
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48. A Randomized, Open-Label, Multicenter, Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of KRT-232 Compared with Ruxolitinib in Patients with Phlebotomy-Dependent Polycythemia Vera
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Gotlib, Jason, Gabrail, Nashat, O'Connell, Casey L., Garcia-Delgado, Regina, Sbardellati, Timothy, Rothbaum, Wayne M., McGreivy, Jesse, Harrison, Claire N, and Kiladjian, Jean-Jacques
- Abstract
Background:Polycythemia vera (PV) is a myeloproliferative neoplasm (MPN) characterized by clonal stem cell proliferation of the erythroid, myeloid, and megakaryocytic lines. The predominant clinical characteristic is an increase in red cell mass, resulting in hyperviscosity of the blood, which is responsible for most symptoms during early stages of disease. Disease progression typically results in symptomatic splenomegaly and severe constitutional symptoms, causing significant morbidity and a shortened life expectancy. Patients with PV may develop cardiovascular complications, myelofibrosis (MF), myelodysplasia, or acute myeloid leukemia (AML). Long-term (20-year) survival for PV is 18%, highlighting the poor long-term prognosis and need for additional therapies. Phlebotomy and low-dose aspirin are the standard of care for initial treatment; hydroxyurea (HU) remains the myelosuppressive agent of choice, despite the increased potential for leukemic transformation, estimated at 10% after 13 years of exposure. The Janus kinase (JAK) inhibitor ruxolitinib is approved in the US and Europe for the treatment of patients who have had an inadequate response to or are intolerant of HU. In clinical trials, ruxolitinib produced responses in 23% of patients, compared with <1% in patients receiving best available therapy (Verstovsek, et al. Haematologica. 2016). Despite this significant improvement, there remains a substantial unmet need for patients with PV who are resistant to or intolerant of HU. more...
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- 2019
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49. Pharmacokinetic Exposure Equivalence and Preliminary Efficacy and Safety from a Randomized Cross over Phase 3 Study (ASCERTAIN study) of an Oral Hypomethylating Agent ASTX727 (cedazuridine/decitabine) Compared to IV Decitabine
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Garcia-Manero, Guillermo, McCloskey, James, Griffiths, Elizabeth A., Yee, Karen W.L., Zeidan, Amer M., Al-Kali, Aref, Dao, Kim-Hien, Deeg, H. Joachim, Patel, Prapti A., Sabloff, Mitchell, Keating, Mary-Margaret, Zhu, Nancy, Gabrail, Nashat Y., Fazal, Salman, Maly, Joseph, Odenike, Olatoyosi, Shastri, Aditi, DeZern, Amy E., O'Connell, Casey L., Roboz, Gail J., Oganesian, Aram, Hao, Yong, Keer, Harold N., Azab, Mohammad, and Savona, Michael R. more...
- Abstract
Garcia-Manero: Amphivena: Consultancy, Research Funding; Helsinn: Research Funding; Novartis: Research Funding; AbbVie: Research Funding; Celgene: Consultancy, Research Funding; Astex: Consultancy, Research Funding; Onconova: Research Funding; H3 Biomedicine: Research Funding; Merck: Research Funding. Griffiths:New Link Genetics: Consultancy; Astex Phramaceuticals/Otsuka Pharmaceuticals: Consultancy, Research Funding; Persimmune: Consultancy; Boston Scientific: Consultancy; Genentech, Inc.: Research Funding; Genentech, Inc.: Research Funding; Novartis Inc.: Consultancy; Novartis Inc.: Consultancy; Partner Therapeutics: Consultancy; Astex Phramaceuticals/Otsuka Pharmaceuticals: Consultancy, Research Funding; Onconova Therapeutics: Other: PI on a clinical trial; Celgene, Inc: Consultancy, Research Funding; Abbvie, Inc.: Consultancy; Celgene, Inc: Consultancy, Research Funding; Persimmune: Consultancy; Partner Therapeutics: Consultancy; Boston Scientific: Consultancy; New Link Genetics: Consultancy; Onconova Therapeutics: Other: PI on a clinical trial; Abbvie, Inc.: Consultancy, PI on a clinical trial; Appelis Pharmaceuticals: Other: PI on a clinical trial; Appelis Pharmaceuticals: Other: PI on a clinical trial. Yee:Celgene: Honoraria, Research Funding; Novartis: Honoraria, Research Funding. Zeidan:Ariad: Honoraria; Acceleron Pharma: Consultancy, Honoraria, Research Funding; Celgene Corporation: Consultancy, Honoraria, Research Funding; Abbvie: Consultancy, Honoraria, Research Funding; Otsuka: Consultancy, Honoraria, Research Funding; Pfizer: Consultancy, Honoraria, Research Funding; Medimmune/AstraZeneca: Research Funding; Astellas: Honoraria; Seattle Genetics: Honoraria; Cardinal Health: Honoraria; Novartis: Honoraria; Agios: Honoraria; Daiichi Sankyo: Honoraria; BeyondSpring: Honoraria; Boehringer-Ingelheim: Consultancy, Honoraria, Research Funding; Trovagene: Consultancy, Honoraria, Research Funding; Incyte: Consultancy, Honoraria, Research Funding; Takeda: Consultancy, Honoraria, Research Funding; ADC Therapeutics: Research Funding; Jazz: Honoraria. Al-Kali:Astex Pharmaceuticals, Inc.: Research Funding. Dao:Incyte Corporation: Membership on an entity's Board of Directors or advisory committees, Research Funding. Patel:Celgene: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Dava Oncology: Honoraria; France Foundation: Honoraria. Sabloff:Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; ASTX: Membership on an entity's Board of Directors or advisory committees, Research Funding; Sanofi Canada: Research Funding; Actinium Pharmaceuticals, Inc: Membership on an entity's Board of Directors or advisory committees; Pfizer Canada: Honoraria, Membership on an entity's Board of Directors or advisory committees; Jazz Pharmaceuticals: Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis Pharmaceuticals: Honoraria, Membership on an entity's Board of Directors or advisory committees; Astellas Pharma Canada: Honoraria, Membership on an entity's Board of Directors or advisory committees. Keating:Sanofi: Membership on an entity's Board of Directors or advisory committees; Hoffman La Roche: Membership on an entity's Board of Directors or advisory committees; Shire: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; Seattle Genetics: Consultancy; Celgene: Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria. Fazal:Janssen: Honoraria, Speakers Bureau; Takeda: Honoraria, Speakers Bureau; Gilead: Consultancy, Honoraria, Speakers Bureau; Pfizer: Speakers Bureau; Novartis: Consultancy, Honoraria, Speakers Bureau; Incyte: Consultancy, Honoraria, Speakers Bureau; BMS: Consultancy, Honoraria, Speakers Bureau; Jazz: Consultancy, Honoraria, Speakers Bureau; Celgene: Speakers Bureau; Karyopharm: Honoraria, Speakers Bureau. Odenike:AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen Oncology: Research Funding; Astra Zeneca: Research Funding; Gilead Sciences: Research Funding; Agios: Research Funding; CTI/Baxalta: Research Funding; Astex Pharmaceuticals: Research Funding; Incyte: Research Funding; NS Pharma: Research Funding; Oncotherapy: Research Funding. DeZern:Astex Pharmaceuticals, Inc.: Consultancy; Celgene: Consultancy. O'Connell:Astex: Membership on an entity's Board of Directors or advisory committees, Research Funding; Genentech: Research Funding; Pfizer: Membership on an entity's Board of Directors or advisory committees; BMS: Membership on an entity's Board of Directors or advisory committees; Shionogi: Membership on an entity's Board of Directors or advisory committees. Roboz:Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees; Jazz: Consultancy, Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees; Orsenix: Consultancy, Membership on an entity's Board of Directors or advisory committees; Otsuka: Consultancy, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees; Trovagene: Consultancy, Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees; Sandoz: Consultancy, Membership on an entity's Board of Directors or advisory committees; Roche/Genentech: Consultancy, Membership on an entity's Board of Directors or advisory committees; MEI Pharma: Consultancy, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees; Eisai: Consultancy, Membership on an entity's Board of Directors or advisory committees; Daiichi Sankyo: Consultancy, Membership on an entity's Board of Directors or advisory committees; Celltrion: Consultancy, Membership on an entity's Board of Directors or advisory committees; Bayer: Consultancy, Membership on an entity's Board of Directors or advisory committees; Astellas: Consultancy, Membership on an entity's Board of Directors or advisory committees; AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Actinium: Consultancy, Membership on an entity's Board of Directors or advisory committees; Agios: Consultancy, Membership on an entity's Board of Directors or advisory committees; Amphivena: Consultancy, Membership on an entity's Board of Directors or advisory committees; Argenx: Consultancy, Membership on an entity's Board of Directors or advisory committees; Astex: Consultancy, Membership on an entity's Board of Directors or advisory committees. Oganesian:Astex Pharmaceuticals, Inc.: Employment. Hao:Astex Pharmaceuticals, Inc.: Employment. Keer:Astex Pharmaceuticals, Inc.: Employment. Azab:Astex Pharmaceuticals, Inc.: Employment. Savona:Incyte Corporation: Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene Corporation: Membership on an entity's Board of Directors or advisory committees; AbbVie: Membership on an entity's Board of Directors or advisory committees; Boehringer Ingelheim: Patents & Royalties; Sunesis: Research Funding; Takeda: Membership on an entity's Board of Directors or advisory committees, Research Funding; TG Therapeutics: Membership on an entity's Board of Directors or advisory committees, Research Funding; Selvita: Membership on an entity's Board of Directors or advisory committees; Karyopharm Therapeutics: Consultancy, Equity Ownership, Membership on an entity's Board of Directors or advisory committees. more...
- Published
- 2019
- Full Text
- View/download PDF
50. Pharmacokinetic Exposure Equivalence and Preliminary Efficacy and Safety from a Randomized Cross over Phase 3 Study (ASCERTAIN study) of an Oral Hypomethylating Agent ASTX727 (cedazuridine/decitabine) Compared to IV Decitabine
- Author
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Garcia-Manero, Guillermo, McCloskey, James, Griffiths, Elizabeth A., Yee, Karen W.L., Zeidan, Amer M., Al-Kali, Aref, Dao, Kim-Hien, Deeg, H. Joachim, Patel, Prapti A., Sabloff, Mitchell, Keating, Mary-Margaret, Zhu, Nancy, Gabrail, Nashat Y., Fazal, Salman, Maly, Joseph, Odenike, Olatoyosi, Shastri, Aditi, DeZern, Amy E., O'Connell, Casey L., Roboz, Gail J., Oganesian, Aram, Hao, Yong, Keer, Harold N., Azab, Mohammad, and Savona, Michael R. more...
- Abstract
Introduction:
- Published
- 2019
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- View/download PDF
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