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MDV3100

DRUG10 trials

Sponsors

Astellas Pharma Global Development Inc., Pfizer, Astellas Pharma Inc, Astellas Pharma Global Development, Inc., Astellas Pharma Europe B.V.

Conditions

Castration Resistant Prostate Cancer (CRPC)Drug-Drug InteractionHealthy SubjectsHormone Refractory Prostate CancerKidney DiseasesMDV3100Metastatic Castration-Resistant Prostate CancerPharmacokinetics

Phase 1

A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer
CompletedNCT00510718
PfizerHormone Refractory Prostate Cancer, Prostate Cancer
Start: 2007-07-23End: 2018-04-02Updated: 2019-10-03
A Study of MDV3100 to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of in Prostate Cancer Patients
CompletedNCT01284920
Astellas Pharma IncCastration Resistant Prostate Cancer (CRPC), Prostate Cancer, Prostate Neoplasms
Start: 2010-11-02End: 2014-07-02Updated: 2024-11-21
Safety and Tolerability Study of MDV3100 in Combination With Docetaxel in Men With Advanced Prostate Cancer
CompletedNCT01565928
PfizerProstate Cancer
Start: 2012-01-24End: 2018-02-26Updated: 2019-04-22
Hepatic Impairment Study With MDV3100 in Subjects With Mild and Moderate Hepatic Impairment Compared to a Healthy Control Group
CompletedNCT01901133
Astellas Pharma Europe B.V.Healthy Subjects, Kidney Diseases, Pharmacokinetics of MDV3100
Start: 2011-10-31End: 2012-01-31Updated: 2014-09-15
Drug-drug Interaction Study With MDV3100 and a Cocktail of Substrates
CompletedNCT01911728
Astellas Pharma Europe B.V.Castration Resistant Prostate Cancer (CRPC), Pharmacokinetics of MDV3100
Start: 2011-07-25End: 2012-02-21Updated: 2017-06-26
A Study to Compare Capsule and Tablet Forms of MDV3100 (Enzalutamide) After Administration of a Single Set Dose Under Fasted Conditions in Healthy Male Subjects
CompletedNCT01911741
Astellas Pharma Europe B.V.Castration Resistant Prostate Cancer (CRPC), Healthy Subjects, MDV3100 +1
Start: 2012-11-30End: 2013-03-31Updated: 2013-07-30
A Study to Explore the Routes of Elimination of MDV3100
CompletedNCT01911715
Astellas Pharma Europe B.V.Healthy Subjects, Pharmacokinetics of MDV3100
Start: 2011-04-30End: 2011-07-31Updated: 2013-07-30
Drug-drug Interaction Study With MDV3100 (ASP9785) and Gemfibrozil and Itraconazole
CompletedNCT01913379
Astellas Pharma Europe B.V.Drug-Drug Interaction, Healthy Subjects, Pharmacokinetics
Start: 2011-08-31End: 2011-12-31Updated: 2013-08-01

Phase 2

A Phase 2 Open-label Extension Study for Subjects with Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
Active, not recruitingCTIS2023-510298-33-00
Astellas Pharma Global Development Inc.Prostate Cancer
Start: 2016-11-29Target: 251Updated: 2025-11-11

Unknown Phase

Provide Expanded Access to MDV3100 and Monitor Its Safety in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
NCT01606982
Astellas Pharma Global Development, Inc.Metastatic Castration-Resistant Prostate Cancer
Updated: 2017-02-17

Related Papers

Safety of continued administration of enzalutamide in patients with prostate cancer who showed benefit from prior exposure: A phase 2 open-label extension study.
Journal of Clinical Oncology2018-02-201 citations
A comparison of the pharmacokinetics and safety of enzalutamide in subjects with hepatic impairment and matched healthy subjects.
2017-03-014 citations
A multicenter phase I/II study of enzalutamide in Japanese patients with castration-resistant prostate cancer
International Journal of Clinical Oncology2016-01-2110 citations
Safety results of the enzalutamide expanded access program in the United States and Canada for patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel.
Journal of Clinical Oncology2014-05-202 citations
Antitumour activity of MDV3100 in castration-resistant prostate cancer: a phase 1-2 study.
2010-04-14780 citations