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137 results on '"Moes, A. J."'

4. A Systematic Evaluation of Cost-Saving Dosing Regimens for Therapeutic Antibodies and Antibody-Drug Conjugates for the Treatment of Lung Cancer

Author

ter Heine, Rob, van den Heuvel, Michel M., Piet, Berber, Deenen, Maarten J., van der Wekken, Anthonie J., Hendriks, Lizza E. L., Croes, Sander, van Geel, Robin M. J. M., Jansman, Frank G. A., Boshuizen, Rogier C., Franssen, Eric J. F., Smit, Arthur A. J., Dumoulin, Daphne W., Oude Munnink, Thijs H., Smit, Egbert F., Derijks, Hieronymus J., van der Leest, Cor H., Hendrikx, Jeroen J. M. A., Moes, Dirk J. A. R., and de Rouw, Nikki

Published
2023
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8. Early Conversion to Prednisolone/Everolimus as an Alternative Weaning Regimen Associates With Beneficial Renal Transplant Histology and Function: The Randomized-Controlled MECANO Trial

Author

Bemelman, F.J., de Fijter, J.W., Kers, J., Meyer, C., Peters-Sengers, H., de Maar, E.F., van der Pant, K.A.M.I., de Vries, A.P.J., Sanders, J.-S., Zwinderman, A., Idu, M.M., Berger, S., Reinders, M.E.J., Krikke, C., Bajema, I.M., van Dijk, M.C., ten Berge, I.J.M., Ringers, J., Lardy, J., Roelen, D., Moes, D.-J., Florquin, S., and Homan van der Heide, J.J.

Published
2017
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15. Analysing the molecular landscape of squamous cell carcinoma through simultaneous targeted DNA and RNA-based next-generation sequencing

Author

Moes-Sosnowska, J, primary, Skupinska, M, additional, Lechowicz, U, additional, Skronska, P, additional, Szczepulska-Wojcik, E, additional, Stepniewska, A, additional, Rozy, A, additional, Langfort, R, additional, Rudzinski, P, additional, Orlowski, T, additional, Popiel, D, additional, Wieczorek, M, additional, and Chorostowska-Wynimko, J, additional

Published
2022
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16. EP16.03-014 Simultaneous Detection of FGFR Gene Aberrations in Squamous Non-small Cell Lung Cancer Using Targeted DNA- and RNA-based NGS

Author

Moes-Sosnowska, J., primary, Skupinska, M., additional, Lechowicz, U., additional, Skronska, P., additional, Szczepulska-Wojcik, E., additional, Stepniewska, A., additional, Rozy, A., additional, Langfort, R., additional, Rudzinski, P., additional, Orlowski, T., additional, Popiel, D., additional, Wieczorek, M., additional, and Chorostowska-Wynimko, J., additional

Published
2022
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17. Impact of Treosulfan Exposure on Early and Long-Term Clinical Outcomes in Pediatric Allogeneic Hematopoietic Stem Cell Transplantation Recipients: A Prospective Multicenter Study

Author

van der Stoep, M. Y. E. C., Bertaina, A., Moes, D. J. A. R., Algeri, M., Bredius, R. G. M., Smiers, F. J. W., Berghuis, D., Buddingh, E. P., Mohseny, A. B., Guchelaar, H. -J., Locatelli, Franco, Zwaveling, J., Lankester, A. C., Locatelli F. (ORCID:0000-0002-7976-3654), van der Stoep, M. Y. E. C., Bertaina, A., Moes, D. J. A. R., Algeri, M., Bredius, R. G. M., Smiers, F. J. W., Berghuis, D., Buddingh, E. P., Mohseny, A. B., Guchelaar, H. -J., Locatelli, Franco, Zwaveling, J., Lankester, A. C., and Locatelli F. (ORCID:0000-0002-7976-3654)

Abstract

Treosulfan-based conditioning has gained popularity in pediatric allogeneic hematopoietic stem cell transplantation (HSCT) because of its presumed favorable efficacy and toxicity profile. Treosulfan is used in standardized dosing regimens based on body surface area. The relationships between systemic treosulfan exposure and early and long-term clinical outcomes in pediatric patients undergoing allogeneic HSCT for nonmalignant diseases remain unclear. In this a multicenter, prospective observational study, we assessed the association between treosulfan exposure and early and, in particular, long-term clinical outcomes. Our study cohort comprised 110 pediatric patients with nonmalignant diseases who underwent HSCT between 2011 and 2019 in Leiden, The Netherlands and Rome, Italy. Blood samples were collected, and treosulfan area under the receiver operating characteristic curve (AUC0-∞) was estimated as a measure of exposure. Cox proportional hazard survival analyses were performed to assess the relationships between treosulfan exposure and overall survival (OS) and event-free survival (EFS). The predictive value of systemic treosulfan exposure for the occurrence of toxicity within 28 days was evaluated using a multivariable logistic regression analysis. In the overall cohort, OS and EFS at 2 years were 89.0% and 75.3%, respectively, with an excellent OS of 97% in children age <2 years. The occurrence of grade II-IV acute graft-versus-host disease, the level of 1-year whole blood chimerism, and 2-year OS and EFS were not correlated with treosulfan exposure. The occurrence of skin toxicity (odds ratio [OR], 3.97; 95% confidence interval [CI], 1.26-13.68; P = .02) and all-grade mucositis (OR, 4.43; 95% CI, 1.43-15.50; P = .02), but not grade ≥2 mucositis (OR, 1.51; 95% CI, 0.52 to 4.58; P = .46) was related to high treosulfan exposure (>1750 mg*h/L). Our study demonstrates that standardized treosulfan-based conditioning results in a favorable OS and EFS in infants

Published
2022

21. Personalized Therapy for Mycophenolate: Consensus Report by the International Association of Therapeutic Drug Monitoring and Clinical Toxicology

Author

UCL - SSS/LDRI - Louvain Drug Research Institute, UCL - SSS/IREC/LTAP - Louvain Centre for Toxicology and Applied Pharmacology, Bergan, Stein, Brunet, Mercè, Hesselink, Dennis A., Johnson-Davis, Kamisha L., Kunicki, Paweł K., Lemaitre, Florian, Marquet, Pierre, Molinaro, Mariadelfina, Noceti, Ofelia, Pattanaik, Smita, Pawinski, Tomasz, Seger, Christoph, Shipkova, Maria, Swen, Jesse J., van Gelder, Teun, Venkataramanan, Raman, Wieland, Eberhard, Woillard, Jean-Baptiste, Zwart, Tom C., Barten, Markus J., Budde, Klemens, Dieterlen, Maja-Theresa, Elens, Laure, Haufroid, Vincent, Masuda, Satohiro, Millan, Olga, Mizuno, Tomoyuki, Moes, Dirk J. A. R., Oellerich, Michael, Picard, Nicolas, Salzmann, Linda, Tönshoff, Burkhard, van Schaik, Ron H. N., Vethe, Nils Tore, Vinks, Alexander A., Wallemacq, Pierre, Åsberg, Anders, Langman, Loralie J., UCL - SSS/LDRI - Louvain Drug Research Institute, UCL - SSS/IREC/LTAP - Louvain Centre for Toxicology and Applied Pharmacology, Bergan, Stein, Brunet, Mercè, Hesselink, Dennis A., Johnson-Davis, Kamisha L., Kunicki, Paweł K., Lemaitre, Florian, Marquet, Pierre, Molinaro, Mariadelfina, Noceti, Ofelia, Pattanaik, Smita, Pawinski, Tomasz, Seger, Christoph, Shipkova, Maria, Swen, Jesse J., van Gelder, Teun, Venkataramanan, Raman, Wieland, Eberhard, Woillard, Jean-Baptiste, Zwart, Tom C., Barten, Markus J., Budde, Klemens, Dieterlen, Maja-Theresa, Elens, Laure, Haufroid, Vincent, Masuda, Satohiro, Millan, Olga, Mizuno, Tomoyuki, Moes, Dirk J. A. R., Oellerich, Michael, Picard, Nicolas, Salzmann, Linda, Tönshoff, Burkhard, van Schaik, Ron H. N., Vethe, Nils Tore, Vinks, Alexander A., Wallemacq, Pierre, Åsberg, Anders, and Langman, Loralie J.

Abstract

When mycophenolic acid (MPA) was originally marketed for immunosuppressive therapy, fixed doses were recommended by the manufacturer. Awareness of the potential for a more personalized dosing has led to development of methods to estimate MPA area under the curve based on the measurement of drug concentrations in only a few samples. This approach is feasible in the clinical routine and has proven successful in terms of correlation with outcome. However, the search for superior correlates has continued, and numerous studies in search of biomarkers that could better predict the perfect dosage for the individual patient have been published. As it was considered timely for an updated and comprehensive presentation of consensus on the status for personalized treatment with MPA, this report was prepared following an initiative from members of the International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT). Topics included are the criteria for analytics, methods to estimate exposure including pharmacometrics, the potential influence of pharmacogenetics, development of biomarkers, and the practical aspects of implementation of target concentration intervention. For selected topics with sufficient evidence, such as the application of limited sampling strategies for MPA area under the curve, graded recommendations on target ranges are presented. To provide a comprehensive review, this report also includes updates on the status of potential biomarkers including those which may be promising but with a low level of evidence. In view of the fact that there are very few new immunosuppressive drugs under development for the transplant field, it is likely that MPA will continue to be prescribed on a large scale in the upcoming years. Discontinuation of therapy due to adverse effects is relatively common, increasing the risk for late rejections, which may contribute to graft loss. Therefore, the continued search for innovative methods to better personali

Published
2021

22. POS1256 SINGLE DOSE TOCILIZUMAB PHARMACOKINETICS IN GLUCOCORTICOID PRE-TREATED COVID-19 PATIENTS DURING CYTOKINE STORM SYNDROME HYPERINFLAMMATORY EPISODE: LESS IS MORE

Author

Boone, N., primary, Ramiro, S., additional, Moes, D. J., additional, Mostard, R., additional, Magro Checa, C., additional, Van Dongen, C., additional, Gronenschild, M., additional, Van Haren, E., additional, Buijs, J., additional, Peeters, R., additional, Wong, D., additional, and Landewé, R. B. M., additional

Published
2021
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23. Personalized Therapy for Mycophenolate: Consensus Report by the International Association of Therapeutic Drug Monitoring and Clinical Toxicology

Author

Bergan, Stein, primary, Brunet, Mercè, additional, Hesselink, Dennis A., additional, Johnson-Davis, Kamisha L., additional, Kunicki, Paweł K., additional, Lemaitre, Florian, additional, Marquet, Pierre, additional, Molinaro, Mariadelfina, additional, Noceti, Ofelia, additional, Pattanaik, Smita, additional, Pawinski, Tomasz, additional, Seger, Christoph, additional, Shipkova, Maria, additional, Swen, Jesse J., additional, van Gelder, Teun, additional, Venkataramanan, Raman, additional, Wieland, Eberhard, additional, Woillard, Jean-Baptiste, additional, Zwart, Tom C., additional, Barten, Markus J., additional, Budde, Klemens, additional, Dieterlen, Maja-Theresa, additional, Elens, Laure, additional, Haufroid, Vincent, additional, Masuda, Satohiro, additional, Millan, Olga, additional, Mizuno, Tomoyuki, additional, Moes, Dirk J. A. R., additional, Oellerich, Michael, additional, Picard, Nicolas, additional, Salzmann, Linda, additional, Tönshoff, Burkhard, additional, van Schaik, Ron H. N., additional, Vethe, Nils Tore, additional, Vinks, Alexander A., additional, Wallemacq, Pierre, additional, Åsberg, Anders, additional, and Langman, Loralie J., additional

Published
2021
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25. P35.08 RNA-Based Gene Alteration and Expression Analysis in Sq-NSCLC with known FGFR1 Amplification and Protein Expression Status

Author

Moes-Sosnowska, J., primary, Rozy, A., additional, Skupinska, M., additional, Lechowicz, U., additional, Szczepulska-Wojcik, E., additional, Langfort, R., additional, Rudzinski, P., additional, Orlowski, T., additional, Popiel, D., additional, Wieczorek, M., additional, Stańczak, A., additional, and Chorostowska-Wynimko, J., additional

Published
2021
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28. A Phase 1 Dose‐Escalation Study of Low‐Dose Metronomic Treatment With Novel Oral Paclitaxel Formulations in Combination With Ritonavir in Patients With Advanced Solid Tumors

Author

Weger, Vincent A., primary, Vermunt, Marit A.C., additional, Stuurman, Frederik E., additional, Burylo, Artur M., additional, Damoiseaux, David, additional, Hendrikx, Jeroen J.M.A., additional, Sawicki, Emilia, additional, Moes, Johannes J., additional, Huitema, Alwin D.R., additional, Nuijen, Bastiaan, additional, Rosing, Hilde, additional, Mergui‐Roelvink, Marja, additional, Beijnen, Jos H., additional, and Marchetti, Serena, additional

Published
2020
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31. Therapeutic drug monitoring of oral anticancer drugs - preliminary results of a prospective study

Author

Groenland, S. L., Van Eerden, R. A. G., Koolen, S. L., Moes, D. J. A. R., Desar, I. M. E., Touw, D. J., Imholz, A. L. T., Reyners, A. K. L., Gelderblom, H., van Erp, N. P., Mathijssen, R. H. J., Huitema, A. D. R., Steeghs, N., Biopharmaceuticals, Discovery, Design and Delivery (BDDD), Groningen Research Institute for Asthma and COPD (GRIAC), Critical care, Anesthesiology, Peri-operative and Emergency medicine (CAPE), Pharmaceutical Analysis, Guided Treatment in Optimal Selected Cancer Patients (GUTS), Targeted Gynaecologic Oncology (TARGON), and Medicinal Chemistry and Bioanalysis (MCB)

Published
2019

32. A Phase I Dose Escalation Study of Once-Weekly Oral Administration of Docetaxel as ModraDoc001 Capsule or ModraDoc006 Tablet in Combination with Ritonavir

Author

de Weger, Vincent A, Stuurman, Frederik E, Koolen, Stijn L W, Moes, Johannes J, Hendrikx, Jeroen J M A, Sawicki, Emilia, Thijssen, Bas, Keessen, Marianne, Rosing, Hilde, Mergui-Roelvink, Marja, Huitema, Alwin D R, Nuijen, Bastiaan, Beijnen, Jos H, Schellens, Jan H M, Marchetti, Serena, de Weger, Vincent A, Stuurman, Frederik E, Koolen, Stijn L W, Moes, Johannes J, Hendrikx, Jeroen J M A, Sawicki, Emilia, Thijssen, Bas, Keessen, Marianne, Rosing, Hilde, Mergui-Roelvink, Marja, Huitema, Alwin D R, Nuijen, Bastiaan, Beijnen, Jos H, Schellens, Jan H M, and Marchetti, Serena

Abstract

PURPOSE: Oral bioavailability of docetaxel is poor. Absorption could be improved by development of pharmaceutical formulations based on docetaxel solid dispersions, denoted ModraDoc001 capsule and ModraDoc006 tablet (both 10 mg) and coadministration of ritonavir, an inhibitor of CYP3A4 and P-glycoprotein. In this study, the safety, MTD, recommended phase II dose (RP2D), pharmacokinetics, and preliminary antitumor activity of oral docetaxel combined with ritonavir in a once-weekly continuous schedule was investigated.PATIENTS AND METHODS: Patients with metastatic solid tumors were included. Dose escalation was performed using a classical 3+3 design. Pharmacokinetic sampling was performed for up to 48 hours after drug administration. Safety was evaluated using CTCAE v3.0. Antitumor activity was assessed according to RECIST v1.0.RESULTS: Sixty-seven patients were treated at weekly docetaxel dosages ranging from 30 to 80 mg in combination with 100- or 200-mg ritonavir. Most common toxicities were nausea, vomiting, diarrhea and fatigue, mostly of grade 1-2 severity. No hypersensitivity reactions were observed. The area under the plasma concentration-time curve (AUC0-48) of docetaxel at the RP2D of once-weekly 60-mg ModraDoc001 capsule with 100-mg ritonavir was 1,000 ± 687 ng/mL/hour and for once-weekly 60-mg ModraDoc006 tablet with 100-mg ritonavir, the AUC0-48 was 1,790 ± 819 ng/mL/hour. Nine partial responses were reported as best response to treatment.CONCLUSIONS: Oral administration of once-weekly docetaxel as ModraDoc001 capsule or ModraDoc006 tablet in combination with ritonavir is feasible. The RP2D for both formulations is 60-mg ModraDoc with 100-mg ritonavir. Antitumor activity is considered promising.

Published
2019

33. A phase I dose escalation study of once weekly oral administration of docetaxel as ModraDoc001 capsule or ModraDoc006 tablet in combination with ritonavir

Author

de Weger, Vincent Anne, Stuurman, Frederik E, Koolen, Stijn Lw, Moes, Johannes J, Hendrikx, Jeroen J M A, Sawicki, Emilia, Thijssen, Bas, Keessen, Marianne, Rosing, Hilde, Mergui-Roelvink, M, Huitema, Alwin D R, Nuijen, Bastiaan, Beijnen, Jos H, Schellens, Jan H M, Marchetti, Serena, de Weger, Vincent Anne, Stuurman, Frederik E, Koolen, Stijn Lw, Moes, Johannes J, Hendrikx, Jeroen J M A, Sawicki, Emilia, Thijssen, Bas, Keessen, Marianne, Rosing, Hilde, Mergui-Roelvink, M, Huitema, Alwin D R, Nuijen, Bastiaan, Beijnen, Jos H, Schellens, Jan H M, and Marchetti, Serena

Published
2019

34. A Phase I Dose Escalation Study of Once-Weekly Oral Administration of Docetaxel as ModraDoc001 Capsule or ModraDoc006 Tablet in Combination with Ritonavir

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, de Weger, Vincent A, Stuurman, Frederik E, Koolen, Stijn L W, Moes, Johannes J, Hendrikx, Jeroen J M A, Sawicki, Emilia, Thijssen, Bas, Keessen, Marianne, Rosing, Hilde, Mergui-Roelvink, Marja, Huitema, Alwin D R, Nuijen, Bastiaan, Beijnen, Jos H, Schellens, Jan H M, Marchetti, Serena, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, de Weger, Vincent A, Stuurman, Frederik E, Koolen, Stijn L W, Moes, Johannes J, Hendrikx, Jeroen J M A, Sawicki, Emilia, Thijssen, Bas, Keessen, Marianne, Rosing, Hilde, Mergui-Roelvink, Marja, Huitema, Alwin D R, Nuijen, Bastiaan, Beijnen, Jos H, Schellens, Jan H M, and Marchetti, Serena

Published
2019

35. A phase I dose escalation study of once weekly oral administration of docetaxel as ModraDoc001 capsule or ModraDoc006 tablet in combination with ritonavir

Author

Cancer, Apotheek Onderzoek, de Weger, Vincent Anne, Stuurman, Frederik E, Koolen, Stijn Lw, Moes, Johannes J, Hendrikx, Jeroen J M A, Sawicki, Emilia, Thijssen, Bas, Keessen, Marianne, Rosing, Hilde, Mergui-Roelvink, M, Huitema, Alwin D R, Nuijen, Bastiaan, Beijnen, Jos H, Schellens, Jan H M, Marchetti, Serena, Cancer, Apotheek Onderzoek, de Weger, Vincent Anne, Stuurman, Frederik E, Koolen, Stijn Lw, Moes, Johannes J, Hendrikx, Jeroen J M A, Sawicki, Emilia, Thijssen, Bas, Keessen, Marianne, Rosing, Hilde, Mergui-Roelvink, M, Huitema, Alwin D R, Nuijen, Bastiaan, Beijnen, Jos H, Schellens, Jan H M, and Marchetti, Serena

Published
2019

36. Population pharmacokinetics of treosulfan in paediatric patients undergoing hematopoietic stem cell transplantation

Author

van der Stoep, M. Y. E. C., Zwaveling, J., Bertaina, A., Locatelli, Franco, Guchelaar, H. J., Lankester, A. C., Moes, D. J. A. R., Locatelli F. (ORCID:0000-0002-7976-3654), van der Stoep, M. Y. E. C., Zwaveling, J., Bertaina, A., Locatelli, Franco, Guchelaar, H. J., Lankester, A. C., Moes, D. J. A. R., and Locatelli F. (ORCID:0000-0002-7976-3654)

Abstract

Aims: Treosulfan is an alkylating agent increasingly used prior to haematopoietic stem cell transplantation. The aim of this study was to develop a population pharmacokinetic (PK) model of treosulfan in paediatric haematopoietic stem cell transplantation recipients and to explore the effect of potential covariates on treosulfan PK. Also, a limited sampling model (LSM) will be developed to accurately predict treosulfan exposure suitable for a therapeutic drug monitoring setting. Methods: In this multicentre study, 91 patients, receiving a total dose of 30, 36 or 42 g/m2 treosulfan, administered over 3 consecutive days, were enrolled. A population PK model was developed and demographic factors, as well as laboratory parameters, were included as potential covariates. In addition, a LSM was developed using data from 28 patients. Results: A 2-compartment model with first order elimination best described the data. Bodyweight with allometric scaling and maturation function were identified as significant predictors of treosulfan clearance. Treosulfan clearance reaches 90% of adult values at 4 postnatal years. A model-based dosing table is presented to target an exposure of 1650 mg*h/L (population median) for different weight and age groups. Samples taken at 1.5, 4 and 7 hours after start of infusion resulted in the best limited sampling strategy. Conclusions: This study provides a treosulfan population PK model in children and captures the developmental changes in clearance. A 3-point LSM allows for accurate and precise estimation of treosulfan exposure.

Published
2019

37. A Phase I Dose Escalation Study of Once-Weekly Oral Administration of Docetaxel as ModraDoc001 Capsule or ModraDoc006 Tablet in Combination with Ritonavir

Author

de Weger, Vincent A., primary, Stuurman, Frederik E., additional, Koolen, Stijn L.W., additional, Moes, Johannes J., additional, Hendrikx, Jeroen J.M.A., additional, Sawicki, Emilia, additional, Thijssen, Bas, additional, Keessen, Marianne, additional, Rosing, Hilde, additional, Mergui-Roelvink, Marja, additional, Huitema, Alwin D.R., additional, Nuijen, Bastiaan, additional, Beijnen, Jos H., additional, Schellens, Jan H.M., additional, and Marchetti, Serena, additional

Published
2019
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42. A Phase 1 Dose‐Escalation Study of Low‐Dose Metronomic Treatment With Novel Oral Paclitaxel Formulations in Combination With Ritonavir in Patients With Advanced Solid Tumors.

Author

Weger, Vincent A., Vermunt, Marit A.C., Stuurman, Frederik E., Burylo, Artur M., Damoiseaux, David, Hendrikx, Jeroen J.M.A., Sawicki, Emilia, Moes, Johannes J., Huitema, Alwin D.R., Nuijen, Bastiaan, Rosing, Hilde, Mergui‐Roelvink, Marja, Beijnen, Jos H., and Marchetti, Serena

Subjects
RITONAVIR, PACLITAXEL, CYTOCHROME P-450, TUMORS, THERAPEUTICS, PHARMACOKINETICS
Abstract

ModraPac001 (MP1) and ModraPac005 (MP5) are novel oral paclitaxel formulations that are coadministered with the cytochrome P450 3A4 inhibitor ritonavir (r), enabling daily low‐dose metronomic (LDM) treatment. The primary aim of this study was to determine the safety, pharmacokinetics and maximum tolerated dose (MTD) of MP1/r and MP5/r. The second aim was to establish the recommended phase 2 dose (RP2D) as LDM treatment. This was an open‐label phase 1 trial. Patients with advanced solid tumors were enrolled according to a classical 3+3 design. After initial employment of the MP1 capsule, the MP5 tablet was introduced. Safety was assessed using the Common Terminology Criteria for Adverse Events version 4.02. Pharmacokinetic sampling was performed on days 1, 2, 8, and 22 for determination of paclitaxel and ritonavir plasma concentrations. In this study, 37 patients were treated with up to twice‐daily 30‐mg paclitaxel combined with twice‐daily 100‐mg ritonavir (MP5/r 30‐30/100‐100) in 9 dose levels. Dose‐limiting toxicities were nausea, (febrile) neutropenia, dehydration and vomiting. At the MTD/RP2D of MP5/r 20‐20/100‐100, the maximum paclitaxel plasma concentration and area under the concentration‐time curve until 24 hours were 34.6 ng/mL (coefficient of variation, 79%) and 255 ng • h/mL (coefficient of variation, 62%), respectively. Stable disease was observed as best response in 15 of 31 evaluable patients. Based on these results, LDM therapy with oral paclitaxel coadministrated with ritonavir was considered feasible and safe. The MTD and RP2D were determined as MP5/r 20‐20/100‐100. Further clinical development of MP5/r as an LDM concept, including potential combination treatment, is warranted. [ABSTRACT FROM AUTHOR]

Published
2021
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44. A Phase I Dose Escalation Study of Once-Weekly Oral Administration of Docetaxel as ModraDoc001 Capsule or ModraDoc006 Tablet in Combination with Ritonavir

Author

de Weger, Vincent A, Stuurman, Frederik E, Koolen, Stijn L W, Moes, Johannes J, Hendrikx, Jeroen J M A, Sawicki, Emilia, Thijssen, Bas, Keessen, Marianne, Rosing, Hilde, Mergui-Roelvink, Marja, Huitema, Alwin D R, Nuijen, Bastiaan, Beijnen, Jos H, Schellens, Jan H M, Marchetti, Serena, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Afd Pharmacoepi & Clinical Pharmacology, and Pharmacoepidemiology and Clinical Pharmacology

Subjects
Adult, Male, Cancer Research, Dose, Nausea, Administration, Oral, Capsules, Docetaxel, Pharmacology, 030226 pharmacology & pharmacy, Drug Administration Schedule, 03 medical and health sciences, 0302 clinical medicine, Pharmacokinetics, Oral administration, Neoplasms, Antineoplastic Combined Chemotherapy Protocols, medicine, Journal Article, Humans, Aged, Ritonavir, business.industry, Oral Docetaxel, Middle Aged, Bioavailability, Treatment Outcome, Oncology, 030220 oncology & carcinogenesis, Retreatment, Female, medicine.symptom, business, medicine.drug, Tablets
Abstract

Purpose: Oral bioavailability of docetaxel is poor. Absorption could be improved by development of pharmaceutical formulations based on docetaxel solid dispersions, denoted ModraDoc001 capsule and ModraDoc006 tablet (both 10 mg) and coadministration of ritonavir, an inhibitor of CYP3A4 and P-glycoprotein. In this study, the safety, MTD, recommended phase II dose (RP2D), pharmacokinetics, and preliminary antitumor activity of oral docetaxel combined with ritonavir in a once-weekly continuous schedule was investigated. Patients and Methods: Patients with metastatic solid tumors were included. Dose escalation was performed using a classical 3+3 design. Pharmacokinetic sampling was performed for up to 48 hours after drug administration. Safety was evaluated using CTCAE v3.0. Antitumor activity was assessed according to RECIST v1.0. Results: Sixty-seven patients were treated at weekly docetaxel dosages ranging from 30 to 80 mg in combination with 100- or 200-mg ritonavir. Most common toxicities were nausea, vomiting, diarrhea and fatigue, mostly of grade 1–2 severity. No hypersensitivity reactions were observed. The area under the plasma concentration–time curve (AUC0–48) of docetaxel at the RP2D of once-weekly 60-mg ModraDoc001 capsule with 100-mg ritonavir was 1,000 ± 687 ng/mL/hour and for once-weekly 60-mg ModraDoc006 tablet with 100-mg ritonavir, the AUC0–48 was 1,790 ± 819 ng/mL/hour. Nine partial responses were reported as best response to treatment. Conclusions: Oral administration of once-weekly docetaxel as ModraDoc001 capsule or ModraDoc006 tablet in combination with ritonavir is feasible. The RP2D for both formulations is 60-mg ModraDoc with 100-mg ritonavir. Antitumor activity is considered promising.

Published
2017

45. Autologous bone marrow‐derived mesenchymal stromal cell therapy with early tacrolimus withdrawal: The randomized prospective, single‐center, open‐label TRITON study

Author

Reinders, Marlies E. J., Groeneweg, Koen E., Hendriks, Sanne H., Bank, Jonna R., Dreyer, Geertje J., Vries, Aiko P. J., Pel, Melissa, Roelofs, Helene, Huurman, Volkert A. L., Meij, Paula, Moes, Dirk J. A. R., Fibbe, Willem E., Claas, Frans H. J., Roelen, Dave L., Kooten, Cees, Kers, Jesper, Heidt, Sebastiaan, Rabelink, Ton J., and Fijter, Johan W.

Abstract

After renal transplantation, there is a need for immunosuppressive regimens which effectively prevent allograft rejection, while preserving renal function and minimizing side effects. From this perspective, mesenchymal stromal cell (MSC) therapy is of interest. In this randomized prospective, single‐center, open‐label trial, we compared MSCs infused 6 and 7 weeks after renal transplantation and early tacrolimus withdrawal with a control tacrolimus group. Primary end point was quantitative evaluation of interstitial fibrosis in protocol biopsies at 4 and 24 weeks posttransplant. Secondary end points included acute rejection, graft loss, death, renal function, adverse events, and immunological responses. Seventy patients were randomly assigned of which 57 patients were included in the final analysis (29 MSC; 28 controls). Quantitative progression of fibrosis failed to show benefit in the MSC group and GFR remained stable in both groups. One acute rejection was documented (MSC group), while subclinical rejection in week 24 protocol biopsies occurred in seven patients (four MSC; three controls). In the MSC group, regulatory T cell numbers were significantly higher compared to controls (p= .014, week 24). In conclusion, early tacrolimus withdrawal with MSC therapy was safe and feasible without increased rejection and with preserved renal function. MSC therapy is a potentially useful approach after renal transplantation. TRITON, a randomized, prospective, single‐center, open‐label study, shows that autologous mesenchymal stromal cell therapy and early tacrolimus withdrawal was feasible and safe, without increased rejection and with preserved renal function.

Published
2021
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47. A dose-escalation study of bi-daily once weekly oral docetaxel either as ModraDoc001 or ModraDoc006 combined with ritonavir

Author

de Weger, Vincent A, Stuurman, Frederik E, Hendrikx, Jeroen J M A, Moes, Johannes J, Sawicki, Emilia, Huitema, Alwin D R, Nuijen, Bastiaan, Thijssen, Bas, Rosing, Hilde, Keessen, Marianne, Mergui-Roelvink, Marja, Beijnen, Jos H, Schellens, Jan H M, Marchetti, Serena, de Weger, Vincent A, Stuurman, Frederik E, Hendrikx, Jeroen J M A, Moes, Johannes J, Sawicki, Emilia, Huitema, Alwin D R, Nuijen, Bastiaan, Thijssen, Bas, Rosing, Hilde, Keessen, Marianne, Mergui-Roelvink, Marja, Beijnen, Jos H, Schellens, Jan H M, and Marchetti, Serena

Abstract

INTRODUCTION: Two solid dispersions of docetaxel (denoted ModraDoc001 capsule and ModraDoc006 tablet (both 10 mg)) were co-administered with 100 mg ritonavir (/r) and investigated in a bi-daily once weekly (BIDW) schedule. Safety, maximum tolerated dose (MTD), pharmacokinetics (PK) and preliminary activity were explored.METHODS: Adult patients with metastatic solid tumours were included in two dose-escalation arms. PK sampling was performed during the first week and the second or third week. Safety was evaluated using US National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0. Antitumour activity was assessed every 6 weeks according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.0.RESULTS: ModraDoc001 capsule/r and ModraDoc006 tablet/r were administered to 17 and 28 patients, respectively. The most common adverse events were nausea, vomiting, diarrhoea and fatigue, mostly of grade 1-2 severity. Grade 3/4 neutropenia/neutropenic fever was observed in 2 patients (4%). The MTD was determined as 20/20 mg ModraDoc001/r and 30/20 mg ModraDoc006/r (morning/afternoon dose) once weekly. The mean area under the plasma concentration-time curve (AUC0-48) ± standard deviation at the MTD for ModraDoc001/r and ModraDoc006/r were 686 ± 388 ng/ml*h and 1126 ± 382 ng/ml*h, respectively. Five partial responses were reported as best response to treatment.CONCLUSION: Oral administration of BIDW ModraDoc001/r or ModraDoc006/r is feasible. The once weekly 30/20 mg ModraDoc006 tablet/r dose-level was selected for future clinical development. Antitumour activity is promising.

Published
2017

48. Identification of 12 new susceptibility loci for different histotypes of epithelial ovarian cancer

Author

Phelan, C. (Catherine), Kuchenbaecker, K.B. (Karoline), Tyrer, J.P. (Jonathan P.), Kar, S.P. (Siddhartha P.), Lawrenson, K. (Kate), Winham, S.J. (Stacey J.), Dennis, J. (Joe), Pirie, A. (Ailith), Riggan, M.J. (Marjorie J.), Chornokur, G. (Ganna), Earp, M.A. (Madalene A.), Lyra, P.C. (Paulo C.), Lee, J.M. (Janet M.), Coetzee, S. (Simon), Beesley, J. (Jonathan), McGuffog, L. (Lesley), Soucy, P. (Penny), Dicks, E. (Ed), Lee, A. (Andrew), Barrowdale, D. (Daniel), Lecarpentier, J. (Julie), Leslie, G. (Goska), Aalfs, C.M. (Cora), Aben, K.K.H. (Katja), Adams, M. (Marcia), Adlard, J.W. (Julian), Andrulis, I.L. (Irene), Anton-Culver, H. (Hoda), Antonenkova, N. (Natalia), Aravantinos, G. (Gerasimos), Arnold, N. (Norbert), Arun, B.K. (Banu), Arver, B. (Brita), Azzollini, J., Balmana, J. (Judith), Banerjee, S. (Susana), Barjhoux, L. (Laure), Barkardottir, R.B. (Rosa B.), Bean, Y. (Yukie), Beckmann, M.W. (Matthias), Beeghly-Fadiel, A. (Alicia), Benítez, J. (Javier), Bermisheva, M. (Marina), Bernardini, M.Q. (Marcus Q.), Birrer, M.J. (Michael J.), Bjorge, L. (Line), Black, A., Blankstein, K. (Kenneth), Blok, M.J. (Marinus), Bodelon, C. (Clara), Bogdanova, N. (Natalia), Bojesen, A. (Anders), Bonanni, B. (Bernardo), Borg, Å. (Åke), Bradbury, A.R. (Angela R.), Brenton, J.D. (James D.), Brewer, C. (Carole), Brinton, L.A. (Louise), Broberg, P. (Per), Brooks-Wilson, A. (Angela), Bruinsma, F. (Fiona), Brunet, J. (Joan), Buecher, B. (Bruno), Butzow, R. (Ralf), Buys, S.S. (Saundra), Caldes, T. (Trinidad), Caligo, M.A. (Maria A.), Campbell, I. (Ian), Cannioto, R. (Rikki), Carney, M.E. (Michael), Cescon, T. (Terence), Chan, S. (Salina), Chang-Claude, J. (Jenny), Chanock, S.J. (Stephen), Chen, X.Q. (Xiao Qing), Chiew, Y.-E. (Yoke-Eng), Chiquette, J. (Jocelyne), Chung, W. (Wendy), Claes, K. (Kathleen), Conner, T. (Thomas), Cook, L.S. (Linda S.), Cook, J. (Jackie), Cramer, D.W. (Daniel), Cunningham, J.M. (Julie), D'Aloisio, A.A. (Aimee A.), Daly, M.B. (Mary), Damiola, F. (Francesca), Damirovna, S.D. (Sakaeva Dina), Dansonka-Mieszkowska, A. (Agnieszka), Dao, F. (Fanny), Davidson, R. (Rosemarie), DeFazio, A. (Anna), Delnatte, C.D. (Capucine), Doheny, K.F. (Kimberly), Díez, O. (Orland), Ding, Y.C. (Yuan Chun), Doherty, J.A. (Jennifer), Domchek, S.M. (Susan), Dorfling, C.M. (Cecilia), Dörk, T. (Thilo), Dossus, L. (Laure), Duran, M. (Mercedes), Dürst, M. (Matthias), Dworniczak, B. (Bernd), Eccles, D. (Diana), Edwards, T. (Todd), Eeles, R. (Rosalind), Eilber, U. (Ursula), Ejlertsen, B. (Bent), Ekici, A.B. (Arif), Ellis, S. (Steve), Elvira, M. (Mingajeva), Eng, K.H. (Kevin H.), Engel, C. (Christoph), Evans, D.G. (Gareth), Fasching, P.A. (Peter), Ferguson, S. (Sarah), Ferrer, S.F., Flanagan, J.M. (James), Fogarty, Z.C. (Zachary C.), Fortner, R.T. (Renée T.), Fostira, F. (Florentia), Foulkes, W.D. (William D.), Fountzilas, G. (George), Fridley, B.L. (Brooke), Friebel, M.O.W. (Mark ), Friedman, E. (Eitan), Frost, D. (Debra), Ganz, P.A. (Patricia), Garber, J. (Judy), García, M.J. (María J.), Garcia-Barberan, V. (Vanesa), Gehrig, P.A. (Paola A.), Gentry-Maharaj, A. (Aleksandra), Gerdes, A-M. (Anne-Marie), Giles, G.G. (Graham G.), Glasspool, R. (Rosalind), Glendon, G. (Gord), Godwin, A.K. (Andrew K.), Radice, P. (Paolo), Goranova, T. (Teodora), Gore, M. (Martin), Greene, M.H. (Mark H.), Gronwald, J. (Jacek), Gruber, S.B. (Stephen), Hahnen, E. (Eric), Haiman, C.A. (Christopher), Håkansson, N. (Niclas), Hamann, U. (Ute), Hansen, T.V.O. (Thomas V.O.), Harrington, P.A. (Patricia A.), Harris, H.R. (Holly), Hauke, J. (Jan), Hein, A. (Alexander), Henderson, A. (Alex), Hildebrandt, M.A.T. (Michelle A.T.), Hillemanns, P. (Peter), Hodgson, S. (Shirley), Høgdall, C.K. (Claus), Høgdall, E. (Estrid), Hogervorst, F.B.L. (Frans B. L.), Holland, H. (Helene), Hooning, M.J. (Maartje J.), Hosking, K. (Karen), Huang, R.-Y. (Ruea-Yea), Hulick, P.J. (Peter), Hung, J. (Jillian), Hunter, D.J. (David J.), Huntsman, D.G. (David G.), Huzarski, T. (Tomasz), Imyanitov, E.N. (Evgeny), Isaacs, C. (Claudine), Iversen, E. (Erik), Izatt, L. (Louise), Izquierdo, A. (A.), Jakubowska, A. (Anna), James, P. (Paul), Janavicius, R. (Ramunas), Jernetz, M. (Mats), Jensen, A. (Allan), Jensen, U.B., John, E.M. (Esther), Johnatty, S.E. (Sharon), Jones, M.E. (Michael E.), Kannisto, P. (Päivi), Karlan, B.Y. (Beth), Karnezis, A. (Anthony), Kast, K. (Karin), Kennedy, C.J. (Catherine J.), Khusnutdinova, E.K. (Elza), Kiemeney, L.A.L.M. (Bart), Kiiski, J.I. (Johanna I.), Kim, S.-W. (Sung-Won), Kjaer, M. (Michael), Köbel, M. (Martin), Kopperud, R.K. (Reidun K.), Kruse, T.A. (Torben), Kupryjanczyk, J. (Jolanta), Kwong, A. (Ava), Laitman, Y. (Yael), Lambrechts, D. (Diether), Larrañaga, N. (Nerea), Larson, M.C. (Melissa), Lazaro, C. (Conxi), Le, N.D. (Nhu D.), Le Marchand, L. (Loic), Lee, J.W. (Jong Won), Lele, S.B. (Shashikant B.), Leminen, A. (Arto), Leroux, D. (Dominique), Lester, J. (Jenny), Lesueur, F. (Fabienne), Levine, D.A. (Douglas), Liang, D. (Dong), Liebrich, C. (Clemens), Lilyquist, J. (Jenna), Lipworth, L. (Loren), Lissowska, J. (Jolanta), Lu, K.H. (Karen), Lubinski, J. (Jan), Luccarini, C. (Craig), Lundvall, L. (Lene), Mai, P.L. (Phuong), Mendoza-Fandiño, G. (Gustavo), Manoukian, S. (Siranoush), Massuger, L.F. (Leon), May, T. (Taymaa), Mazoyer, S. (Sylvie), McAlpine, J.N. (Jessica N.), McGuire, V. (Valerie), McLaughlin, J. (John), McNeish, I. (Iain), Meijers-Heijboer, E.J. (Hanne), Meindl, A. (Alfons), Menon, U. (Usha), Mensenkamp, A.R. (Arjen R.), Merritt, M.A. (Melissa A.), Milne, R.L. (Roger), Mitchell, G. (Gillian), Modugno, F. (Francesmary), Moes-Sosnowska, J. (Joanna), Moffitt, M. (Melissa), Montagna, M. (Marco), Moysich, K.B. (Kirsten), Mulligan, A.M. (Anna Marie), Musinsky, J. (Jacob), Nathanson, K.L. (Katherine), Nedergaard, L. (Lotte), Ness, R.B. (Roberta), Neuhausen, S.L. (Susan), Nevanlinna, H. (Heli), Niederacher, D. (Dieter), Nussbaum, R. (Robert), Odunsi, K. (Kunle), Olah, E. (Edith), Olopade, O.I. (Olofunmilayo), Olsson, H. (Håkan), Olswold, C. (Curtis), O'Malley, D.M. (David M.), Ong, K.-R. (Kai-Ren), Onland-Moret, N.C. (Charlotte), Orr, N. (Nick), Orsulic, S. (Sandra), Osorio, A. (Ana), Palli, D. (Domenico), Papi, L. (Laura), Park-Simon, T.-W., Paul, J. (James), Pearce, C.L. (Celeste), Pedersen, I.S. (Inge Søkilde), Peeters, P.H.M., Peissel, B. (Bernard), Peixoto, A. (Ana), Pejovic, T. (Tanja), Pelttari, L.M. (Liisa M.), Permuth, J.B. (Jennifer B.), Peterlongo, P. (Paolo), Pezzani, L. (Lidia), Pfeiler, G. (Georg), Phillips, K.-A. (Kelly-Anne), Piedmonte, M. (Marion), Pike, M.C. (Malcolm), Piskorz, A.M. (Anna M.), Poblete, S.R. (Samantha R.), Pócza, T. (Tímea), Poole, E.M. (Elizabeth M.), Poppe, B. (Bruce), Porteous, M.E. (Mary), Prieur, F. (Fabienne), Prokofyeva, D. (Darya), Pugh, E. (Elizabeth), Pujana, M.A. (Miquel Angel), Pujol, P. (Pascal), Rantala, J. (Johanna), Rappaport-Fuerhauser, C. (Christine), Rennert, G. (Gad), Rhiem, K. (Kerstin), Rice, P. (Patricia), Richardson, A.L. (Andrea), Robson, M. (Mark), Rodriguez, G.C. (Gustavo), Rodríguez-Antona, C. (Cristina), Romm, J. (Jane), Rookus, M.A. (Matti), Rossing, M.A. (Mary Anne), Rothstein, J.H. (Joseph H.), Rudolph, A. (Anja), Runnebaum, I.B. (Ingo), Salvesen, H.B. (Helga), Sandler, D.P. (Dale P.), Schoemaker, M.J. (Minouk J.), Senter, L. (Leigha), Setiawan, V.W. (V. Wendy), Severi, G. (Gianluca), Sharma, P. (Priyanka), Shelford, T. (Tameka), Siddiqui, N. (Nadeem), Side, L. (Lucy), Sieh, W. (Weiva), Singer, C.F. (Christian), Sobol, H. (Hagay), Song, H. (Honglin), Southey, M.C. (Melissa), Spurdle, A.B. (Amanda), Stadler, Z. (Zsofia), Steinemann, D. (Doris), Stoppa-Lyonnet, D. (Dominique), Sucheston-Campbell, L.E. (Lara E.), Sukiennicki, G. (Grzegorz), Sutphen, R. (Rebecca), Sutter, C. (Christian), Swerdlow, A.J. (Anthony ), Szabo, C. (Csilla), Szafron, L. (Lukasz), Tan, Y.Y. (Yen Y.), Taylor, J.A. (Jack A.), Tea, M.-K., Teixeira, P.J., Teo, S.-H. (Soo-Hwang), Terry, K.L. (Kathryn L.), Thompson, P.J. (Pamela J.), Thomsen, L.C.V. (Liv Cecilie Vestrheim), Thull, D.L. (Darcy L.), Tihomirova, L. (Laima), Tinker, A.V. (Anna V.), Tischkowitz, M. (Marc), Tognazzo, S. (Silvia), Toland, A.E. (Amanda Ewart), Tone, A. (Alicia), Trabert, B. (Britton), Travis, S.P.L. (Simon), Trichopoulou, A. (Antonia), Tung, N. (Nadine), Tworoger, S. (Shelley), Van Altena, A.M. (Anne M.), Van Den Berg, D. (David), Van Der Hout, A.H. (Annemarie H.), Luijt, R.B. (Rob) van der, Van Heetvelde, M. (Mattias), Van Nieuwenhuysen, E. (Els), Rensburg, E.J. (Elizabeth) van, Vanderstichele, A. (Adriaan), Varon-Mateeva, R. (Raymonda), Vega, A. (Ana), Edwards, D.V. (Digna Velez), Vergote, I., Vierkant, R.A. (Robert), Vijai, J. (Joseph), Vratimos, A. (Athanassios), Walker, L.J. (Lisa), Walsh, C. (Christine), Wand, D. (Dorothea), Wang-Gohrke, S. (Shan), Wappenschmidt, B. (Barbara), Webb, P.M. (Penelope M.), Weinberg, C.R. (Clarice R.), Weitzel, J.N. (Jeffrey), Wentzensen, N. (N.), Whittemore, A.S. (Alice), Wijnen, J.T. (Juul), Wilkens, L.R. (Lynne), Wolk, K. (Kerstin), Woo, M. (Michelle), Wu, X. (Xifeng), Wu, A.H. (Anna), Yang, H.P. (Hannah), Yannoukakos, D. (Drakoulis), Ziogas, A. (Argyrios), Zorn, K.K. (Kristin K.), Narod, S.A. (Steven A.), Easton, D.F. (Douglas), Amos, W., Schildkraut, J.M. (Joellen), Ramus, S.J. (Susan), Ottini, L. (Laura), Goodman, M.T. (Marc), Park, S.K. (Sue K.), Kelemen, L.E. (Linda), Risch, H. (Harvey), Thomassen, M. (Mads), Offit, K. (Kenneth), Simard, J. (Jacques), Schmutzler, R.K. (Rita), Hazelett, D. (Dennis), Monteiro, A.N.A. (Alvaro N.), Couch, F.J. (Fergus), Berchuck, A. (Andrew), Chenevix-Trench, G. (Georgia), Goode, E.L. (Ellen), Sellers, T.F., Gayther, S.A. (Simon), Antoniou, A.C. (Antonis), Pharoah, P.D.P. (Paul), Phelan, C. (Catherine), Kuchenbaecker, K.B. (Karoline), Tyrer, J.P. (Jonathan P.), Kar, S.P. (Siddhartha P.), Lawrenson, K. (Kate), Winham, S.J. (Stacey J.), Dennis, J. (Joe), Pirie, A. (Ailith), Riggan, M.J. (Marjorie J.), Chornokur, G. (Ganna), Earp, M.A. (Madalene A.), Lyra, P.C. (Paulo C.), Lee, J.M. (Janet M.), Coetzee, S. (Simon), Beesley, J. (Jonathan), McGuffog, L. (Lesley), Soucy, P. (Penny), Dicks, E. (Ed), Lee, A. (Andrew), Barrowdale, D. (Daniel), Lecarpentier, J. (Julie), Leslie, G. (Goska), Aalfs, C.M. (Cora), Aben, K.K.H. (Katja), Adams, M. (Marcia), Adlard, J.W. (Julian), Andrulis, I.L. (Irene), Anton-Culver, H. (Hoda), Antonenkova, N. (Natalia), Aravantinos, G. (Gerasimos), Arnold, N. (Norbert), Arun, B.K. (Banu), Arver, B. (Brita), Azzollini, J., Balmana, J. (Judith), Banerjee, S. (Susana), Barjhoux, L. (Laure), Barkardottir, R.B. (Rosa B.), Bean, Y. (Yukie), Beckmann, M.W. (Matthias), Beeghly-Fadiel, A. (Alicia), Benítez, J. (Javier), Bermisheva, M. (Marina), Bernardini, M.Q. (Marcus Q.), Birrer, M.J. (Michael J.), Bjorge, L. (Line), Black, A., Blankstein, K. (Kenneth), Blok, M.J. (Marinus), Bodelon, C. (Clara), Bogdanova, N. (Natalia), Bojesen, A. (Anders), Bonanni, B. (Bernardo), Borg, Å. (Åke), Bradbury, A.R. (Angela R.), Brenton, J.D. (James D.), Brewer, C. (Carole), Brinton, L.A. (Louise), Broberg, P. (Per), Brooks-Wilson, A. (Angela), Bruinsma, F. (Fiona), Brunet, J. (Joan), Buecher, B. (Bruno), Butzow, R. (Ralf), Buys, S.S. (Saundra), Caldes, T. (Trinidad), Caligo, M.A. (Maria A.), Campbell, I. (Ian), Cannioto, R. (Rikki), Carney, M.E. (Michael), Cescon, T. (Terence), Chan, S. (Salina), Chang-Claude, J. (Jenny), Chanock, S.J. (Stephen), Chen, X.Q. (Xiao Qing), Chiew, Y.-E. (Yoke-Eng), Chiquette, J. (Jocelyne), Chung, W. (Wendy), Claes, K. (Kathleen), Conner, T. (Thomas), Cook, L.S. (Linda S.), Cook, J. (Jackie), Cramer, D.W. (Daniel), Cunningham, J.M. (Julie), D'Aloisio, A.A. (Aimee A.), Daly, M.B. (Mary), Damiola, F. (Francesca), Damirovna, S.D. (Sakaeva Dina), Dansonka-Mieszkowska, A. (Agnieszka), Dao, F. (Fanny), Davidson, R. (Rosemarie), DeFazio, A. (Anna), Delnatte, C.D. (Capucine), Doheny, K.F. (Kimberly), Díez, O. (Orland), Ding, Y.C. (Yuan Chun), Doherty, J.A. (Jennifer), Domchek, S.M. (Susan), Dorfling, C.M. (Cecilia), Dörk, T. (Thilo), Dossus, L. (Laure), Duran, M. (Mercedes), Dürst, M. (Matthias), Dworniczak, B. (Bernd), Eccles, D. (Diana), Edwards, T. (Todd), Eeles, R. (Rosalind), Eilber, U. (Ursula), Ejlertsen, B. (Bent), Ekici, A.B. (Arif), Ellis, S. (Steve), Elvira, M. (Mingajeva), Eng, K.H. (Kevin H.), Engel, C. (Christoph), Evans, D.G. (Gareth), Fasching, P.A. (Peter), Ferguson, S. (Sarah), Ferrer, S.F., Flanagan, J.M. (James), Fogarty, Z.C. (Zachary C.), Fortner, R.T. (Renée T.), Fostira, F. (Florentia), Foulkes, W.D. (William D.), Fountzilas, G. (George), Fridley, B.L. (Brooke), Friebel, M.O.W. (Mark ), Friedman, E. (Eitan), Frost, D. (Debra), Ganz, P.A. (Patricia), Garber, J. (Judy), García, M.J. (María J.), Garcia-Barberan, V. (Vanesa), Gehrig, P.A. (Paola A.), Gentry-Maharaj, A. (Aleksandra), Gerdes, A-M. (Anne-Marie), Giles, G.G. (Graham G.), Glasspool, R. (Rosalind), Glendon, G. (Gord), Godwin, A.K. (Andrew K.), Radice, P. (Paolo), Goranova, T. (Teodora), Gore, M. (Martin), Greene, M.H. (Mark H.), Gronwald, J. (Jacek), Gruber, S.B. (Stephen), Hahnen, E. (Eric), Haiman, C.A. (Christopher), Håkansson, N. (Niclas), Hamann, U. (Ute), Hansen, T.V.O. (Thomas V.O.), Harrington, P.A. (Patricia A.), Harris, H.R. (Holly), Hauke, J. (Jan), Hein, A. (Alexander), Henderson, A. (Alex), Hildebrandt, M.A.T. (Michelle A.T.), Hillemanns, P. (Peter), Hodgson, S. (Shirley), Høgdall, C.K. (Claus), Høgdall, E. (Estrid), Hogervorst, F.B.L. (Frans B. L.), Holland, H. (Helene), Hooning, M.J. (Maartje J.), Hosking, K. (Karen), Huang, R.-Y. (Ruea-Yea), Hulick, P.J. (Peter), Hung, J. (Jillian), Hunter, D.J. (David J.), Huntsman, D.G. (David G.), Huzarski, T. (Tomasz), Imyanitov, E.N. (Evgeny), Isaacs, C. (Claudine), Iversen, E. (Erik), Izatt, L. (Louise), Izquierdo, A. (A.), Jakubowska, A. (Anna), James, P. (Paul), Janavicius, R. (Ramunas), Jernetz, M. (Mats), Jensen, A. (Allan), Jensen, U.B., John, E.M. (Esther), Johnatty, S.E. (Sharon), Jones, M.E. (Michael E.), Kannisto, P. (Päivi), Karlan, B.Y. (Beth), Karnezis, A. (Anthony), Kast, K. (Karin), Kennedy, C.J. (Catherine J.), Khusnutdinova, E.K. (Elza), Kiemeney, L.A.L.M. (Bart), Kiiski, J.I. (Johanna I.), Kim, S.-W. (Sung-Won), Kjaer, M. (Michael), Köbel, M. (Martin), Kopperud, R.K. (Reidun K.), Kruse, T.A. (Torben), Kupryjanczyk, J. (Jolanta), Kwong, A. (Ava), Laitman, Y. (Yael), Lambrechts, D. (Diether), Larrañaga, N. (Nerea), Larson, M.C. (Melissa), Lazaro, C. (Conxi), Le, N.D. (Nhu D.), Le Marchand, L. (Loic), Lee, J.W. (Jong Won), Lele, S.B. (Shashikant B.), Leminen, A. (Arto), Leroux, D. (Dominique), Lester, J. (Jenny), Lesueur, F. (Fabienne), Levine, D.A. (Douglas), Liang, D. (Dong), Liebrich, C. (Clemens), Lilyquist, J. (Jenna), Lipworth, L. (Loren), Lissowska, J. (Jolanta), Lu, K.H. (Karen), Lubinski, J. (Jan), Luccarini, C. (Craig), Lundvall, L. (Lene), Mai, P.L. 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Abstract

To identify common alleles associated with different histotypes of epithelial ovarian cancer (EOC), we pooled data from multiple genome-wide genotyping projects totaling 25,509 EOC cases and 40,941 controls. We identified nine new susceptibility loci for different EOC histotypes: six for serous EOC histotypes (3q28, 4q32.3, 8q21.11, 10q24.33, 18q11.2 and 22q12.1), two for mucinous EOC (3q22.3 and 9q31.1) and one for endometrioid EOC (5q12.3). We then performed meta-analysis on the results for high-grade serous ovarian cancer with the results from analysis of 31,448 BRCA1 and BRCA2 mutation carriers, including 3,887 mutation carriers with EOC. This identified three additional susceptibility loci at 2q13, 8q24.1 and 12q24.31. Integrated analyses of genes and regulatory biofeatures at each locus predicted candidate susceptibility genes, including OBFC1, a new candidate susceptibility gene for low-grade and borderline serous EOC.

Published
2017
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49. A dose-escalation study of bi-daily once weekly oral docetaxel either as ModraDoc001 or ModraDoc006 combined with ritonavir

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, de Weger, Vincent A, Stuurman, Frederik E, Hendrikx, Jeroen J M A, Moes, Johannes J, Sawicki, Emilia, Huitema, Alwin D R, Nuijen, Bastiaan, Thijssen, Bas, Rosing, Hilde, Keessen, Marianne, Mergui-Roelvink, Marja, Beijnen, Jos H, Schellens, Jan H M, Marchetti, Serena, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, de Weger, Vincent A, Stuurman, Frederik E, Hendrikx, Jeroen J M A, Moes, Johannes J, Sawicki, Emilia, Huitema, Alwin D R, Nuijen, Bastiaan, Thijssen, Bas, Rosing, Hilde, Keessen, Marianne, Mergui-Roelvink, Marja, Beijnen, Jos H, Schellens, Jan H M, and Marchetti, Serena

Published
2017

50. A dose-escalation study of bi-daily once weekly oral docetaxel either as ModraDoc001 or ModraDoc006 combined with ritonavir

Author

Apotheek Onderzoek, de Weger, Vincent A, Stuurman, Frederik E, Hendrikx, Jeroen J M A, Moes, Johannes J, Sawicki, Emilia, Huitema, Alwin D.R., Nuijen, Bastiaan, Thijssen, Bas, Rosing, Hilde, Keessen, Marianne, Mergui-Roelvink, Marja, Beijnen, Jos H, Schellens, Jan H M, Marchetti, Serena, Apotheek Onderzoek, de Weger, Vincent A, Stuurman, Frederik E, Hendrikx, Jeroen J M A, Moes, Johannes J, Sawicki, Emilia, Huitema, Alwin D.R., Nuijen, Bastiaan, Thijssen, Bas, Rosing, Hilde, Keessen, Marianne, Mergui-Roelvink, Marja, Beijnen, Jos H, Schellens, Jan H M, and Marchetti, Serena

Published
2017

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