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7 results on '"Gounder, Mrinal M"'

1. Selinexor in Advanced, Metastatic Dedifferentiated Liposarcoma: A Multinational, Randomized, Double-Blind, Placebo-Controlled Trial

Author

Gounder, Mrinal M, Gounder, Mrinal M, Razak, Albiruni Abdul, Somaiah, Neeta, Chawla, Sant, Martin-Broto, Javier, Grignani, Giovanni, Schuetze, Scott M, Vincenzi, Bruno, Wagner, Andrew J, Chmielowski, Bartosz, Jones, Robin L, Riedel, Richard F, Stacchiotti, Silvia, Loggers, Elizabeth T, Ganjoo, Kristen N, Le Cesne, Axel, Italiano, Antoine, del Muro, Xavier Garcia, Burgess, Melissa, Piperno-Neumann, Sophie, Ryan, Christopher, Mulcahy, Mary F, Forscher, Charles, Penel, Nicolas, Okuno, Scott, Elias, Anthony, Hartner, Lee, Philip, Tony, Alcindor, Thierry, Kasper, Bernd, Reichardt, Peter, Lapeire, Lore, Blay, Jean-Yves, Chevreau, Christine, Morales, Claudia Maria Valverde, Schwartz, Gary K, Chen, James L, Deshpande, Hari, Davis, Elizabeth J, Nicholas, Garth, Gröschel, Stefan, Hatcher, Helen, Duffaud, Florence, Herráez, Antonio Casado, Beveridge, Roberto Diaz, Badalamenti, Giuseppe, Eriksson, Mikael, Meyer, Christian, von Mehren, Margaret, Van Tine, Brian A, Götze, Katharina, Mazzeo, Filomena, Yakobson, Alexander, Zick, Aviad, Lee, Alexander, Gonzalez, Anna Estival, Napolitano, Andrea, Dickson, Mark A, Michel, Dayana, Meng, Changting, Li, Lingling, Liu, Jianjun, Ben-Shahar, Osnat, Van Domelen, Dane R, Walker, Christopher J, Chang, Hua, Landesman, Yosef, Shah, Jatin J, Shacham, Sharon, Kauffman, Michael G, Attia, Steven, Gounder, Mrinal M, Gounder, Mrinal M, Razak, Albiruni Abdul, Somaiah, Neeta, Chawla, Sant, Martin-Broto, Javier, Grignani, Giovanni, Schuetze, Scott M, Vincenzi, Bruno, Wagner, Andrew J, Chmielowski, Bartosz, Jones, Robin L, Riedel, Richard F, Stacchiotti, Silvia, Loggers, Elizabeth T, Ganjoo, Kristen N, Le Cesne, Axel, Italiano, Antoine, del Muro, Xavier Garcia, Burgess, Melissa, Piperno-Neumann, Sophie, Ryan, Christopher, Mulcahy, Mary F, Forscher, Charles, Penel, Nicolas, Okuno, Scott, Elias, Anthony, Hartner, Lee, Philip, Tony, Alcindor, Thierry, Kasper, Bernd, Reichardt, Peter, Lapeire, Lore, Blay, Jean-Yves, Chevreau, Christine, Morales, Claudia Maria Valverde, Schwartz, Gary K, Chen, James L, Deshpande, Hari, Davis, Elizabeth J, Nicholas, Garth, Gröschel, Stefan, Hatcher, Helen, Duffaud, Florence, Herráez, Antonio Casado, Beveridge, Roberto Diaz, Badalamenti, Giuseppe, Eriksson, Mikael, Meyer, Christian, von Mehren, Margaret, Van Tine, Brian A, Götze, Katharina, Mazzeo, Filomena, Yakobson, Alexander, Zick, Aviad, Lee, Alexander, Gonzalez, Anna Estival, Napolitano, Andrea, Dickson, Mark A, Michel, Dayana, Meng, Changting, Li, Lingling, Liu, Jianjun, Ben-Shahar, Osnat, Van Domelen, Dane R, Walker, Christopher J, Chang, Hua, Landesman, Yosef, Shah, Jatin J, Shacham, Sharon, Kauffman, Michael G, and Attia, Steven

Abstract

PurposeAntitumor activity in preclinical models and a phase I study of patients with dedifferentiated liposarcoma (DD-LPS) was observed with selinexor. We evaluated the clinical benefit of selinexor in patients with previously treated DD-LPS whose sarcoma progressed on approved agents.MethodsSEAL was a phase II-III, multicenter, randomized, double-blind, placebo-controlled study. Patients age 12 years or older with advanced DD-LPS who had received two-five lines of therapy were randomly assigned (2:1) to selinexor (60 mg) or placebo twice weekly in 6-week cycles (crossover permitted). The primary end point was progression-free survival (PFS). Patients who received at least one dose of study treatment were included for safety analysis (ClinicalTrials.gov identifier: NCT02606461).ResultsTwo hundred eighty-five patients were enrolled (selinexor, n = 188; placebo, n = 97). PFS was significantly longer with selinexor versus placebo: hazard ratio (HR) 0.70 (95% CI, 0.52 to 0.95; one-sided P = .011; medians 2.8 v 2.1 months), as was time to next treatment: HR 0.50 (95% CI, 0.37 to 0.66; one-sided P < .0001; medians 5.8 v 3.2 months). With crossover, no difference was observed in overall survival. The most common treatment-emergent adverse events of any grade versus grade 3 or 4 with selinexor were nausea (151 [80.7%] v 11 [5.9]), decreased appetite (113 [60.4%] v 14 [7.5%]), and fatigue (96 [51.3%] v 12 [6.4%]). Four (2.1%) and three (3.1%) patients died in the selinexor and placebo arms, respectively. Exploratory RNA sequencing analysis identified that the absence of CALB1 expression was associated with longer PFS with selinexor compared with placebo (median 6.9 v 2.2 months; HR, 0.19; P = .001).ConclusionPatients with advanced, refractory DD-LPS showed improved PFS and time to next treatment with selinexor compared with placebo. Supportive care and dose reductions mitigated side effects of selinexor. Prospective validation of CALB1 expression as a predictive biomarker

Published
2022

2. Clinical genomic profiling in the management of patients with soft tissue and bone sarcoma.

Author

Gounder, Mrinal M, Gounder, Mrinal M, Agaram, Narasimhan P, Trabucco, Sally E, Robinson, Victoria, Ferraro, Richard A, Millis, Sherri Z, Krishnan, Anita, Lee, Jessica, Attia, Steven, Abida, Wassim, Drilon, Alexander, Chi, Ping, Angelo, Sandra P D', Dickson, Mark A, Keohan, Mary Lou, Kelly, Ciara M, Agulnik, Mark, Chawla, Sant P, Choy, Edwin, Chugh, Rashmi, Meyer, Christian F, Myer, Parvathi A, Moore, Jessica L, Okimoto, Ross A, Pollock, Raphael E, Ravi, Vinod, Singh, Arun S, Somaiah, Neeta, Wagner, Andrew J, Healey, John H, Frampton, Garrett M, Venstrom, Jeffrey M, Ross, Jeffrey S, Ladanyi, Marc, Singer, Samuel, Brennan, Murray F, Schwartz, Gary K, Lazar, Alexander J, Thomas, David M, Maki, Robert G, Tap, William D, Ali, Siraj M, Jin, Dexter X, Gounder, Mrinal M, Gounder, Mrinal M, Agaram, Narasimhan P, Trabucco, Sally E, Robinson, Victoria, Ferraro, Richard A, Millis, Sherri Z, Krishnan, Anita, Lee, Jessica, Attia, Steven, Abida, Wassim, Drilon, Alexander, Chi, Ping, Angelo, Sandra P D', Dickson, Mark A, Keohan, Mary Lou, Kelly, Ciara M, Agulnik, Mark, Chawla, Sant P, Choy, Edwin, Chugh, Rashmi, Meyer, Christian F, Myer, Parvathi A, Moore, Jessica L, Okimoto, Ross A, Pollock, Raphael E, Ravi, Vinod, Singh, Arun S, Somaiah, Neeta, Wagner, Andrew J, Healey, John H, Frampton, Garrett M, Venstrom, Jeffrey M, Ross, Jeffrey S, Ladanyi, Marc, Singer, Samuel, Brennan, Murray F, Schwartz, Gary K, Lazar, Alexander J, Thomas, David M, Maki, Robert G, Tap, William D, Ali, Siraj M, and Jin, Dexter X

Abstract

There are more than 70 distinct sarcomas, and this diversity complicates the development of precision-based therapeutics for these cancers. Prospective comprehensive genomic profiling could overcome this challenge by providing insight into sarcomas' molecular drivers. Through targeted panel sequencing of 7494 sarcomas representing 44 histologies, we identify highly recurrent and type-specific alterations that aid in diagnosis and treatment decisions. Sequencing could lead to refinement or reassignment of 10.5% of diagnoses. Nearly one-third of patients (31.7%) harbor potentially actionable alterations, including a significant proportion (2.6%) with kinase gene rearrangements; 3.9% have a tumor mutational burden ≥10 mut/Mb. We describe low frequencies of microsatellite instability (<0.3%) and a high degree of genome-wide loss of heterozygosity (15%) across sarcomas, which are not readily explained by homologous recombination deficiency (observed in 2.5% of cases). In a clinically annotated subset of 118 patients, we validate actionable genetic events as therapeutic targets. Collectively, our findings reveal the genetic landscape of human sarcomas, which may inform future development of therapeutics and improve clinical outcomes for patients with these rare cancers.

Published
2022

3. Phase 1 study of the MDM2 inhibitor AMG 232 in patients with advanced P53 wild-type solid tumors or multiple myeloma

Author

Gluck, W. Larry, Gounder, Mrinal M., Frank, Richard, Eskens, Ferry, Blay, Jean Yves, Cassier, Philippe A., Soria, Jean Charles, Chawla, Sant, de Weger, Vincent, Wagner, Andrew J., Siegel, David, De Vos, Filip, Rasmussen, Erik, Henary, Haby A., Gluck, W. Larry, Gounder, Mrinal M., Frank, Richard, Eskens, Ferry, Blay, Jean Yves, Cassier, Philippe A., Soria, Jean Charles, Chawla, Sant, de Weger, Vincent, Wagner, Andrew J., Siegel, David, De Vos, Filip, Rasmussen, Erik, and Henary, Haby A.

Published
2020

4. Phase 1 study of the MDM2 inhibitor AMG 232 in patients with advanced P53 wild-type solid tumors or multiple myeloma

Author

Gluck, W. Larry, Gounder, Mrinal M., Frank, Richard, Eskens, Ferry, Blay, Jean Yves, Cassier, Philippe A., Soria, Jean Charles, Chawla, Sant, de Weger, Vincent, Wagner, Andrew J., Siegel, David, De Vos, Filip, Rasmussen, Erik, Henary, Haby A., Gluck, W. Larry, Gounder, Mrinal M., Frank, Richard, Eskens, Ferry, Blay, Jean Yves, Cassier, Philippe A., Soria, Jean Charles, Chawla, Sant, de Weger, Vincent, Wagner, Andrew J., Siegel, David, De Vos, Filip, Rasmussen, Erik, and Henary, Haby A.

Published
2020

5. Phase 1 study of the MDM2 inhibitor AMG 232 in patients with advanced P53 wild-type solid tumors or multiple myeloma

Author

Gluck, W. Larry, Gounder, Mrinal M., Frank, Richard, Eskens, Ferry, Blay, Jean Yves, Cassier, Philippe A., Soria, Jean Charles, Chawla, Sant, de Weger, Vincent, Wagner, Andrew J., Siegel, David, De Vos, Filip, Rasmussen, Erik, Henary, Haby A., Gluck, W. Larry, Gounder, Mrinal M., Frank, Richard, Eskens, Ferry, Blay, Jean Yves, Cassier, Philippe A., Soria, Jean Charles, Chawla, Sant, de Weger, Vincent, Wagner, Andrew J., Siegel, David, De Vos, Filip, Rasmussen, Erik, and Henary, Haby A.

Published
2020

6. Phase 1 study of the MDM2 inhibitor AMG 232 in patients with advanced P53 wild-type solid tumors or multiple myeloma

Author

UMC Utrecht, MS Medische Oncologie, Cancer, Gluck, W. Larry, Gounder, Mrinal M., Frank, Richard, Eskens, Ferry, Blay, Jean Yves, Cassier, Philippe A., Soria, Jean Charles, Chawla, Sant, de Weger, Vincent, Wagner, Andrew J., Siegel, David, De Vos, Filip, Rasmussen, Erik, Henary, Haby A., UMC Utrecht, MS Medische Oncologie, Cancer, Gluck, W. Larry, Gounder, Mrinal M., Frank, Richard, Eskens, Ferry, Blay, Jean Yves, Cassier, Philippe A., Soria, Jean Charles, Chawla, Sant, de Weger, Vincent, Wagner, Andrew J., Siegel, David, De Vos, Filip, Rasmussen, Erik, and Henary, Haby A.

Published
2020

7. Evaluation of the Safety and Benefit of Phase I Oncology Trials for Patients With Primary CNS Tumors.

Author

Gounder, Mrinal M, Gounder, Mrinal M, Nayak, Lakshmi, Sahebjam, Solmaz, Muzikansky, Alona, Sanchez, Armando J, Desideri, Serena, Ye, Xiaobu, Ivy, S Percy, Nabors, L Burt, Prados, Michael, Grossman, Stuart, DeAngelis, Lisa M, Wen, Patrick Y, Gounder, Mrinal M, Gounder, Mrinal M, Nayak, Lakshmi, Sahebjam, Solmaz, Muzikansky, Alona, Sanchez, Armando J, Desideri, Serena, Ye, Xiaobu, Ivy, S Percy, Nabors, L Burt, Prados, Michael, Grossman, Stuart, DeAngelis, Lisa M, and Wen, Patrick Y

Abstract

PurposePatients with high-grade gliomas (HGG) are frequently excluded from first-in-human solid tumor trials because of perceived poor prognosis, excessive toxicities, concomitant drug interactions, and poor efficacy. We conducted an analysis of outcomes from select, single-agent phase I studies in patients with HGG. We compared outcomes to pooled analysis of published studies in solid tumors with various molecular and cytotoxic drugs evaluated as single agents or as combinations.Patient and methodsIndividual records of patients with recurrent HGG enrolled onto Adult Brain Tumor Consortium trials of single-agent, cytotoxic or molecular agents from 2000 to 2008 were analyzed for baseline characteristics, toxicities, responses, and survival.ResultsOur analysis included 327 patients with advanced, refractory HGG who were enrolled onto eight trials involving targeted molecular (n=5) and cytotoxic (n=3) therapies. At enrollment, patients had a median Karnofsky performance score of 90 and median age of 52 years; 62% were men, 63% had glioblastoma, and the median number of prior systemic chemotherapies was one. Baseline laboratory values were in an acceptable range to meet eligibility criteria. Patients were on the study for a median of two cycles (range, ConclusionPatients with HGG who meet standard eligibility criteria may be good candidates for solid tumor phase I studies with single-agent molecular or cytotoxic drugs with favorable preclinical rationale and pharmacokinetic properties in this population.

Published
2015

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