MEDIVATION, INC. Clinical Trials
Studies registered on ClinicalTrials.gov (U.S. National Library of Medicine) with the company as lead sponsor or collaborator, newest start first. Values are as registered.
- 2017-08-23: Study NCT03246347; Company role Collaborator; Phase Phase 2; Status Active not recruiting.
- 2017-07-04: Study NCT03148795; Company role Collaborator; Phase Phase 2; Status Completed.
- 2017-02-21: Study NCT02997163; Company role Collaborator; Phase Phase 1; Status Completed.
- 2016-12: Study NCT02653989; Company role Lead sponsor; Phase Phase 2; Status Withdrawn.
| Start date | Study | Company role | Phase | Status | Conditions | Enrollment | Completion date |
|---|---|---|---|---|---|---|---|
| 2017-08-23 | NCT03246347 A Trial of Androgen Deprivation, Docetaxel, and Enzalutamide for Metastatic Prostate Cancer | Collaborator Lead: Wake Forest University Health Sciences | Phase 2 | Active not recruiting Results posted | Prostate Cancer; Prostate Adenocarcinoma | 40 | 2028-03 |
| 2017-07-04 | NCT03148795 A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer | Collaborator Lead: Pfizer | Phase 2 | Completed Results posted | Prostate Cancer | 128 | 2023-03-31 |
| 2017-02-21 | NCT02997163 An Open-Label Pharmacokinetics and Safety Study of Talazoparib | Collaborator Lead: Pfizer | Phase 1 | Completed Results posted | Advanced Solid Tumors | 34 | 2019-01-30 |
| 2016-12 | NCT02653989 Efficacy and Safety Study of MDV9300 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) | Lead sponsor | Phase 2 | Withdrawn | Lymphoma, Large B-Cell, Diffuse; Primary Mediastinal Large B-cell Lymphoma; Transformed Indolent Lymphoma | 0 | 2018-08 |
| 2016-11-08 | NCT02921919 Open-Label Extension and Safety Study of Talazoparib | Collaborator Lead: Pfizer | Phase 2 | Completed Results posted | Cancer | 120 | 2021-07-20 |
| 2016-11-07 | NCT03077607 A Study to Evaluate the Effect of Itraconazole and Rifampin on the Pharmacokinetics of Talazoparib in Patients With Advanced Solid Tumors | Collaborator Lead: Pfizer | Phase 1 | Completed Results posted | Advanced Solid Tumors | 36 | 2018-01-20 |
| 2016-10-13 | NCT03042910 A Study to Assess the Effects of Talazoparib on Cardiac Repolarization in Patients With Advanced Solid Tumors | Collaborator Lead: Pfizer | Phase 1 | Completed Results posted | Solid Tumor | 38 | 2017-06-22 |
| 2016-10 | NCT02836028 A Study Evaluating Talazoparib in Relapsed Ovarian, Fallopian Tube, and Peritoneal Cancer | Collaborator Lead: Pfizer | Phase 2 | Withdrawn | Ovarian Cancer | 0 | |
| 2016-09-30 | NCT02997176 An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800) | Collaborator Lead: Pfizer | Phase 1 | Completed Results posted | Advanced Solid Tumors | 38 | 2020-02-12 |
| 2016-09 | NCT03070548 A Study of Talazoparib in Patients With Advanced Solid Tumors | Collaborator Lead: Pfizer | Phase 1 | Completed Results posted | Advanced Solid Tumors | 6 | 2017-06 |
| 2016-09 | NCT02929576 Efficacy and Safety Study of Enzalutamide in Combination With Paclitaxel Chemotherapy or as Monotherapy Versus Placebo With Paclitaxel in Patients With Advanced, Diagnostic-Positive, Triple-Negative Breast Cancer | Collaborator Lead: Pfizer | Phase 3 | Withdrawn | Breast Cancer | 0 | |
| 2016-06-22 | NCT02339168 Enzalutamide and Metformin Hydrochloride in Treating Patients With Hormone-Resistant Prostate Cancer | Collaborator Lead: University of California, Davis | Phase 1 | Completed | Prostate Cancer | 25 | 2025-02-24 |
| 2016-05-19 | NCT02750358 Feasibility Study of Adjuvant Enzalutamide for the Treatment of Early Stage AR (+) Triple Negative Breast Cancer | Collaborator Lead: Memorial Sloan Kettering Cancer Center | Phase 2 | Active not recruiting | Breast Cancer; Early Stage; Triple Negative Breast Cancer | 50 | 2027-05 |
| 2015-10-28 | NCT02441517 A Study of Enzalutamide Re-treatment in Metastatic Castration-resistant Prostate Cancer After Docetaxel and/or Cabazitaxel Treatment | Collaborator Lead: Astellas Pharma Global Development, Inc. | Phase 4 | Terminated Results posted | Metastatic Castration Resistant Prostate Cancer | 4 | 2017-03-15 |
| 2015-09-08 | NCT02495974 European Observational Study of Enzalutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC) | Collaborator Lead: Astellas Pharma Europe Ltd. | Observational | Completed | Metastatic Castration Resistant Prostate Cancer | 1,763 | 2019-02-08 |
| 2015-03-28 | NCT02203695 Randomized Salvage Radiation Therapy Plus Enzalutamide Post Prostatectomy | Collaborator Lead: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Phase 2 | Completed Results posted | Adenocarcinoma of the Prostate | 86 | 2022-12-31 |
| 2014-10-01 | NCT02127151 A Parp Inhibitor (BMN 673) for Inoperable Advanced eNDometrial cAncer | Collaborator Lead: University College, London | Phase 2 | Withdrawn | Endometrial Cancer | 0 | 2017-05-01 |
| 2014-10 | NCT02268175 Enzalutamide/Leuprolide +/- Abiraterone/Pred in Prostate | Collaborator Lead: Dana-Farber Cancer Institute | Phase 2 | Completed Results posted | Prostate Adenocarcinoma; Prostate Cancer; High Risk Prostate Cancer | 75 | 2021-12 |
| 2014-09-23 | NCT01990196 Neoadjuvant Phase 2 Study Comparing the Effects of AR Inhibition With/Without SRC or MEK Inhibition in Prostate Cancer | Collaborator Lead: Jonsson Comprehensive Cancer Center | Phase 2 | Active not recruiting | Prostate Cancer | 45 | 2026-09-30 |
| 2014-06-12 | NCT02049593 PARP Inhibitor BMN-673 and Temozolomide or Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic Solid Tumors | Collaborator Lead: Jonsson Comprehensive Cancer Center | Phase 1 | Completed | Metastatic Cancer; Unspecified Adult Solid Tumor | 44 | 2019-10-07 |
| 2014-04-02 | NCT02023463 Enzalutamide, Radiation Therapy and Hormone Therapy in Treating Patients With Intermediate or High-Risk Prostate Cancer | Collaborator Lead: Thomas Jefferson University | Phase 1 | Active not recruiting | Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer; Stage IV Prostate Cancer | 25 | 2040-01-01 |
| 2014-04 | NCT02057939 Salvage Therapeutic Radiation With Enzalutamide and ADT in Men With Recurrent Prostate Cancer (STREAM) | Collaborator Lead: Duke University | Phase 2 | Completed Results posted | Prostate Cancer | 38 | 2019-06-05 |
| 2014-02 | NCT02028988 Enzalutamide + External Beam Rt For Prostate | Collaborator Lead: Dana-Farber Cancer Institute | Phase 2 | Completed Results posted | Intermediate Risk Prostate Cancer | 64 | 2018-01 |
| 2014-01-22 | NCT01949337 Enzalutamide With or Without Abiraterone and Prednisone in Treating Patients With Castration-Resistant Metastatic Prostate Cancer | Collaborator Lead: Alliance for Clinical Trials in Oncology | Phase 3 | Unknown Results posted | Adenocarcinoma of the Prostate; Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer; Stage IV Prostate Cancer | 1,311 | 2024-08-31 |
| 2013-12-16 | NCT02007512 Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer | Collaborator Lead: Pfizer | Phase 2 | Completed Results posted | Breast Cancer | 247 | 2024-08-23 |
| 2013-12-13 | NCT02034916 A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study) | Collaborator Lead: Pfizer | Phase 2 | Terminated Results posted | Breast Neoplasms; BRCA 1 Gene Mutation; BRCA 2 Gene Mutation | 84 | 2018-10-31 |
| 2013-11-05 | NCT01974765 Enzalutamide in Patients With Androgen Receptor Positive (AR+) Ovarian, Primary Peritoneal or Fallopian Tube Cancer and One, Two or Three Prior Therapies | Collaborator Lead: Memorial Sloan Kettering Cancer Center | Phase 2 | Completed Results posted | Advanced Epithelial Ovarian; Recurrent Epithelial Ovarian; Fallopian Tube; Primary Peritoneal Carcinoma | 59 | 2022-02-28 |
| 2013-10-31 | NCT01946165 Abiraterone Acetate Plus LHRH Agonist and Abiraterone Acetate Plus LHRH Agonist and Enzalutamide | Collaborator Lead: M.D. Anderson Cancer Center | Phase 2 | Completed Results posted | Prostate Cancer | 69 | 2017-07-28 |
| 2013-10-14 | NCT01945775 A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study) | Collaborator Lead: Pfizer | Phase 3 | Completed Results posted | Breast Neoplasms; BRCA 1 Gene Mutation; BRCA 2 Gene Mutation | 431 | 2021-03-05 |
| 2013-10-02 | NCT02225093 A Study to Evaluate How Daily Dosing With Enzalutamide Affects the Metabolism of Caffeine and Dextromethorphan in Men With Prostate Cancer | Collaborator Lead: Astellas Pharma Europe B.V. | Phase 1 | Completed | Pharmacokinetics of Dextromethorphan; Pharmacokinetics of Caffeine; Prostate Cancer | 12 | 2014-02-03 |
| 2013-09-13 | NCT01942837 Study of Enzalutamide in Patients With Castration-resistant Prostate Cancer | Collaborator Lead: Dana-Farber Cancer Institute | Phase 2 | Completed Results posted | Metastatic Castration-resistant Prostate Cancer | 67 | 2022-09-30 |
| 2013-08 | NCT02138162 A Study to Investigate the Effect of Severely Diminished Liver Function on the Metabolism, Safety, and Tolerability of a Single Oral Dose of Enzalutamide in Men | Collaborator Lead: Astellas Pharma Europe B.V. | Phase 1 | Completed | Severe Hepatic Impairment; Normal Hepatic Function | 16 | 2014-03 |
| 2013-07 | NCT02138799 A Study to Evaluate How a Drug That Alters Liver Enzymes (Rifampin) Affects the Metabolism of Enzalutamide in Men | Collaborator Lead: Astellas Pharma Europe B.V. | Phase 1 | Completed | Drug-Drug Interaction (DDI); Healthy Subjects; Pharmacokinetics of Enzalutamide | 28 | 2013-09 |
| 2012-11 | NCT01911741 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 | Collaborator Lead: Astellas Pharma Europe B.V. | Phase 1 | Completed | Healthy Subjects; Castration Resistant Prostate Cancer (CRPC); Relative Bioavailability; MDV3100 | 55 | 2013-03 |
| 2012-11 | NCT01902251 Relative Bioavailability Study of Enzalutamide in Prostate Cancer Patients | Collaborator Lead: Astellas Pharma Europe B.V. | Phase 1 | Completed | Prostate Cancer; Pharmacokinetics of Enzalutamide | 27 | 2013-10 |
| 2012-08 | NCT01663415 A Study to Evaluate the Safety and Efficacy of Enzalutamide in Chemotherapy-Naïve, Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer | Collaborator Lead: Astellas Pharma Global Development, Inc. | Phase 2 | Withdrawn | Metastatic Castration-Resistant Prostate Cancer | 0 | 2014-10 |
| 2011-11 | NCT01435369 Safety, Tolerability and Efficacy Study of the Monoclonal Antibody, CT-011, in Patients With Metastatic Melanoma | Lead sponsor | Phase 2 | Completed | Melanoma; Malignant Melanoma | 103 | 2013-08 |
| 2011-10 | NCT01901133 Hepatic Impairment Study With MDV3100 in Subjects With Mild and Moderate Hepatic Impairment Compared to a Healthy Control Group | Collaborator Lead: Astellas Pharma Europe B.V. | Phase 1 | Completed | Pharmacokinetics of MDV3100; Healthy Subjects; Kidney Diseases | 33 | 2012-01 |
| 2011-08 | NCT01913379 Drug-drug Interaction Study With MDV3100 (ASP9785) and Gemfibrozil and Itraconazole | Collaborator Lead: Astellas Pharma Europe B.V. | Phase 1 | Completed | Healthy Subjects; Pharmacokinetics; Drug-Drug Interaction | 41 | 2011-12 |
| 2011-07-25 | NCT01911728 Drug-drug Interaction Study With MDV3100 and a Cocktail of Substrates | Collaborator Lead: Astellas Pharma Europe B.V. | Phase 1 | Completed | Pharmacokinetics of MDV3100; Castration Resistant Prostate Cancer (CRPC) | 14 | 2012-02-21 |
| 2011-06-30 | NCT01399840 Study of BMN 673, a PARP Inhibitor, in Patients With Advanced Hematological Malignancies | Collaborator Lead: Pfizer | Phase 1 | Completed | Acute Myeloid Leukemia; Myelodysplastic Syndrome; Chronic Lymphocytic Leukemia; Mantle Cell Lymphoma | 33 | 2014-05-31 |
| 2011-05-06 | NCT01302041 A Study to Test if Enzalutamide is Effective and Safe in Prostate Cancer Patients Who Have Never Had Hormone Therapy | Collaborator Lead: Astellas Pharma Inc | Phase 2 | Completed Results posted | Prostate Cancer | 67 | 2017-04-27 |
| 2011-04 | NCT01911715 A Study to Explore the Routes of Elimination of MDV3100 | Collaborator Lead: Astellas Pharma Europe B.V. | Phase 1 | Completed | Healthy Subjects; Pharmacokinetics of MDV3100 | 6 | 2011-07 |
| 2011-01-03 | NCT01286987 Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors | Collaborator Lead: Pfizer | Phase 1 | Completed Results posted | Advanced or Recurrent Solid Tumors; Breast Neoplasms; Ovarian Cancer, Epithelial; Ewing Sarcoma; Small Cell Lung Carcinoma; Prostate Cancer; Pancreas Cancer | 113 | 2017-01-30 |
| 2010-05 | NCT01096602 Blockade of PD-1 in Conjunction With the Dendritic Cell/AML Vaccine Following Chemotherapy Induced Remission | Collaborator Lead: Beth Israel Deaconess Medical Center | Phase 2 | Completed Results posted | Acute Myelogenous Leukemia; AML | 63 | 2025-06 |
| 2010-04 | NCT01152216 An Extension of the CONCERT Protocol (DIM18) | Lead sponsor | Phase 3 | Terminated | Alzheimer's Disease | 672 | |
| 2010-04 | NCT01066546 An Extension To The B1451006 Protocol To Evaluate The Safety and Efficacy of Dimebon In Subjects With Moderate-to-Severe Alzheimer's Disease | Collaborator Lead: Pfizer | Phase 3 | Terminated Results posted | Alzheimer's Disease | 5 | 2010-07 |
| 2010-02 | NCT01085266 An Extension of the HORIZON Protocol Evaluating the Safety of Dimebon (Latrepirdine) in Subjects With Huntington Disease | Lead sponsor | Phase 3 | Terminated | Huntington Disease | 362 | |
| 2009-10 | NCT00990613 A Study Evaluating The Absorption Of Dimebon Into The Body From A Dimebon Solution Applied To The Skin | Collaborator Lead: Pfizer | Phase 1 | Completed | Alzheimer's Disease; Huntington's Disease | 19 | 2010-01 |
| 2009-10 | NCT00988624 A Study In Healthy Volunteers To Estimate The Pharmacokinetics Of Four Modified-Release Formulations Of Dimebon (Latrepirdine) | Collaborator Lead: Pfizer | Phase 1 | Completed | Alzheimer's Disease; Huntington Disease | 20 | 2009-12 |
| 2009-10 | NCT00975481 A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users | Collaborator Lead: Pfizer | Phase 1 | Completed Results posted | Alzheimer's Disease; Huntington's Disease | 36 | 2010-02 |
| 2009-10 | NCT00954590 A Safety and Efficacy Study Evaluating Dimebon (Latrepirdine) in Patients With Moderate to Severe Alzheimer's Disease | Lead sponsor | Phase 3 | Terminated | Moderate to Severe Alzheimer | 89 | |
| 2009-09 | NCT00939783 An Extension To The B1451027 Protocol To Evaluate The Long Term Safety And Tolerability Of Dimebon In Patients With Alzheimer's Disease | Collaborator Lead: Pfizer | Phase 3 | Terminated Results posted | Alzheimer's Disease | 649 | 2010-08 |
| 2009-09 | NCT00912288 A Phase 3 Efficacy Study Of Dimebon In Patients With Moderate To Severe Alzheimer's Disease | Collaborator Lead: Pfizer | Phase 3 | Terminated Results posted | Alzheimer Disease | 86 | 2010-08 |
| 2009-07 | NCT00931073 A Phase I Study To Estimate The Effect Of Ketoconazole And Omeprazole On The Pharmacokinetics Of Dimebon In Healthy Subjects Who Are Normal Or Poor CYP2D6 Metabolizers | Collaborator Lead: Pfizer | Phase 1 | Completed | Alzheimer's Disease; Huntington's Disease | 24 | 2009-10 |
| 2009-07 | NCT00920946 A Safety and Efficacy Study of Dimebon in Patients With Huntington Disease | Lead sponsor | Phase 3 | Completed | Huntington Disease | 403 | |
| 2009-06 | NCT00907322 A Phase 1 Trial To Assess The Safety And Pharmacokinetics Of Single, Ascending, Oral Doses Of Dimebon In Healthy Adults | Collaborator Lead: Pfizer | Phase 1 | Completed | Healthy Volunteers | 12 | 2009-07 |
| 2009-05 | NCT00890305 Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone | Lead sponsor | Phase 2 | Completed | Metastatic Colorectal Cancer | 171 | 2013-03 |
| 2009-03 | NCT00829374 Safety and Efficacy Study Evaluating Dimebon in Patients With Mild to Moderate Alzheimer's Disease on Donepezil | Lead sponsor | Phase 3 | Completed | Alzheimer's Disease | 1,003 | 2011-12 |
| 2009-02 | NCT00838110 A Phase 3 Study To Evaluate The Safety And Tolerability Of Dimebon Patients With Mild To Moderate Alzheimer's Disease | Collaborator Lead: Pfizer | Phase 3 | Completed Results posted | Alzheimer's Disease | 742 | 2010-01 |
| 2009-02 | NCT00831532 Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [Pf-01913539] In Subjects With Hepatic Impairment And Normal Hepatic Function | Collaborator Lead: Pfizer | Phase 1 | Completed | Hepatic Failure | 23 | 2009-08 |
| 2009-02 | NCT00831506 Dimebon (PF-01913539)-Digoxin Drug-Drug Interaction Study In Healthy Subjects | Collaborator Lead: Pfizer | Phase 1 | Completed | Alzheimer Disease; Huntington Disease | 12 | 2009-05 |
| 2009-02 | NCT00827034 A Phase 1, Randomized, Open-Label, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Dimebon (PF 01913539) On The Single-Dose Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy Subjects | Collaborator Lead: Pfizer | Phase 1 | Completed | Alzheimer's Disease; Huntington's Disease | 14 | 2009-04 |
| 2009-02 | NCT00825084 A Phase 1 Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [PF-01913539] In Japanese And Western Healthy Subjects | Collaborator Lead: Pfizer | Phase 1 | Completed | Alzheimer's Disease; Huntington's Disease | 45 | 2009-05 |
| 2009-02 | NCT00824590 A Phase 1, Non-Randomized, Open-Label, Single-Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [PF 01913539] In Subjects With Severely-Impaired And Normal Renal Function | Collaborator Lead: Pfizer | Phase 1 | Completed | Alzheimer's Disease; Huntington's Disease | 20 | 2009-10 |
| 2008-12 | NCT00829816 Safety and Tolerability of Dimebon in Patients on Memantine, and Memantine Plus Donepezil | Lead sponsor | Phase 1 | Completed | Alzheimer's Disease | 46 | 2010-08 |
| 2008-11 | NCT00788047 A Phase 1 Study To Evaluate The Effect Of Dimebon On The Pharmacokinetics Of Dextromethorphan | Collaborator Lead: Pfizer | Phase 1 | Completed | Huntington Disease; Alzheimer Disease | 14 | 2009-01 |
| 2008-05 | NCT00675623 A Safety and Efficacy Study of Oral Dimebon in Patients With Mild-To-Moderate Alzheimer's Disease | Lead sponsor | Phase 3 | Completed | Alzheimer's Disease | 598 | |
| 2008-04 | NCT00704782 Study of Combination Therapy With Dimebon and Donepezil (Aricept) in Patients With Alzheimer's Disease | Lead sponsor | Phase 2 | Terminated | Alzheimer's Disease | 50 | 2010-08 |
| 2007-07 | NCT00497159 A Study of the Novel Drug Dimebon in Patients With Huntington's Disease | Lead sponsor | Phase 2 | Completed | Huntington's Disease | 91 | 2008-06 |
| 2006-10 | NCT00387270 Safety Study of the Novel Drug Dimebon to Treat Patients With Huntington's Disease | Lead sponsor | Phase 1, Phase 2 | Completed | Huntington's Disease | 9 | 2007-03 |
| 2005-09 | NCT00377715 Double-blind, Placebo-controlled Study of Oral Dimebon in Subjects With Mild to Moderate Alzheimer's Disease | Lead sponsor | Phase 2 | Completed | Alzheimer's Disease | 183 | |
| NCT01606982 Provide Expanded Access to MDV3100 and Monitor Its Safety in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy | Collaborator Lead: Astellas Pharma Global Development, Inc. | Expanded_access | Approved for marketing | Metastatic Castration-Resistant Prostate Cancer |