CLINICAL TRIALS PROFILE FOR ABIRATERONE ACETATE
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505(b)(2) Clinical Trials for abiraterone acetate
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| New Combination | NCT01845792 ↗ | Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel in Patients With Prostate Cancer | Terminated | Janssen Services, LLC | Phase 2 | 2013-07-01 | Patients are being asked to take place in this research study because they have advanced prostate cancer that has gotten worse after other treatments. If they join this study they will receive a new combination of drugs that are used to treat prostate cancer. |
| New Combination | NCT01845792 ↗ | Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel in Patients With Prostate Cancer | Terminated | University of Colorado, Denver | Phase 2 | 2013-07-01 | Patients are being asked to take place in this research study because they have advanced prostate cancer that has gotten worse after other treatments. If they join this study they will receive a new combination of drugs that are used to treat prostate cancer. |
| New Formulation | NCT01897389 ↗ | A Study to Assess the Relative Bioavailability of 4 New Abiraterone Acetate Tablet Formulations With Respect to the Current Commercial Abiraterone Acetate Tablet Under Fasted Conditions in Healthy Male Participants | Completed | Janssen Research & Development, LLC | Phase 1 | 2013-07-01 | The purpose of this study is to evaluate the relative bioavailability of 4 new formulations of abiraterone acetate compared to the current commercial formulation. |
| New Formulation | NCT04887506 ↗ | TAVT-45 (Abiraterone Acetate) Granules in Patients With Prostate Cancer | Recruiting | Tavanta Therapeutics | Phase 3 | 2021-04-14 | The purpose of this study is to investigate the safety and efficacy of a new formulation of an existing drug product called TAVT-45 in patients with metastatic prostate cancer. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for abiraterone acetate
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00473512 ↗ | A Safety and Efficacy Study of Abiraterone Acetate in Participants With Prostate Cancer Who Have Failed Hormone Therapy | Completed | Cougar Biotechnology, Inc. | Phase 1/Phase 2 | 2005-11-01 | The purpose of this study is to determine the maximum tolerated dose and evaluate the safety, tolerability, and activity at the recommended dose (maximum tolerated dose [MTD]) of abiraterone acetate (also known as CB7630) in participants with hormone refractory prostate (gland that makes fluid that aids movement of sperm) cancer (HRPC). |
| NCT00473746 ↗ | Abiraterone Acetate Dose-Escalation Study in Hormone Refractory Prostate Cancer | Completed | Janssen Research & Development, LLC | Phase 1/Phase 2 | 2006-06-01 | The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and anti-tumor activities of abiraterone acetate (also referred to as CB7630) in patients with hormone refractory prostate cancer (HRPC). |
| NCT00474383 ↗ | An Safety and Efficacy Study of Abiraterone Acetate in Participants With Advanced Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy | Completed | Cougar Biotechnology, Inc. | Phase 2 | 2006-11-01 | The purpose of this study is to assess the anti-tumor activities and safety of abiraterone acetate in participants with prostate cancer (a disease in which cells in the prostate gland [a gland in the male reproductive system found below the bladder and in front of the rectum] become abnormal and start to grow uncontrollably, forming tumors) who have failed taxane (docetaxel)-based chemotherapy. |
| NCT00485303 ↗ | An Efficacy and Safety Study of Abiraterone Acetate and Prednisone in Participants With Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy | Completed | Cougar Biotechnology, Inc. | Phase 2 | 2007-06-01 | The purpose of this study is to evaluate the efficacy and safety of abiraterone acetate in participants with advanced prostate cancer (a disease in which cells in the prostate gland become abnormal and start to grow uncontrollably, forming tumors). |
| NCT00544440 ↗ | An Observational Study of Continuous Oral Dosing of Abiraterone Acetate in Castration-Resistant Prostate Cancer Patients Evaluating Androgens and Steroid Metabolites in Bone Marrow Plasma | Completed | Janssen Research & Development, LLC | Phase 2 | 2007-10-01 | The purpose of this study is to investigate the effect of abiraterone acetate on levels of androgens and steroid metabolites in bone marrow plasma of patients with metastatic castration-resistant prostate cancer (CRPC). |
| NCT00600535 ↗ | A Pharmacokinetics Study to Assess Abiraterone Acetate Capsule and Tablet Formulations in Patients With Prostate Cancer | Completed | Cougar Biotechnology, Inc. | Phase 1 | 2007-07-01 | The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations change over time) of capsule and tablet formulations of CB7630 (abiraterone acetate) taken with and without food in patients with prostate cancer. |
| NCT00638690 ↗ | Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy | Completed | Cougar Biotechnology, Inc. | Phase 3 | 2008-05-01 | This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer (CRPC) who have failed one or two chemotherapy regimens. At least one of the previous chemotherapies must have contained docetaxel. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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