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Last Updated: August 6, 2020

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CLINICAL TRIALS PROFILE FOR ABIRATERONE ACETATE

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505(b)(2) Clinical Trials for Abiraterone Acetate

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
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 Active, not recruiting 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 Active, not recruiting 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.
>Trial Type >Trial ID >Title >Status >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 >Phase >Start Date >Summary

Clinical Trial Conditions for Abiraterone Acetate

Condition Name

Condition Name for Abiraterone Acetate
Intervention Trials
Prostate Cancer 84
Prostatic Neoplasms 15
Stage IV Prostate Cancer 14
Prostate Neoplasms 14
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Condition MeSH

Condition MeSH for Abiraterone Acetate
Intervention Trials
Prostatic Neoplasms 173
Adenocarcinoma 23
Carcinoma 14
Breast Neoplasms 6
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Clinical Trial Locations for Abiraterone Acetate

Trials by Country

Trials by Country for Abiraterone Acetate
Location Trials
United States 703
Canada 75
Spain 44
United Kingdom 43
Japan 25
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Trials by US State

Trials by US State for Abiraterone Acetate
Location Trials
California 51
New York 44
Texas 41
Massachusetts 33
Maryland 30
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Clinical Trial Progress for Abiraterone Acetate

Clinical Trial Phase

Clinical Trial Phase for Abiraterone Acetate
Clinical Trial Phase Trials
Phase 4 8
Phase 3 26
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Abiraterone Acetate
Clinical Trial Phase Trials
Not yet recruiting 51
Active, not recruiting 50
Recruiting 49
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Clinical Trial Sponsors for Abiraterone Acetate

Sponsor Name

Sponsor Name for Abiraterone Acetate
Sponsor Trials
Janssen Research & Development, LLC 32
National Cancer Institute (NCI) 27
Cougar Biotechnology, Inc. 12
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Sponsor Type

Sponsor Type for Abiraterone Acetate
Sponsor Trials
Other 157
Industry 156
NIH 29
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