A Safety Study of Abiraterone Acetate Administered in Combination With Docetaxel in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Phase 1 Completed 22 enrolled Cougar Biotechnology, Inc.

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the maximum safe dose of abiraterone acetate administered in combination with docetaxel plus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC).

Timeline

Start: 2011-09-01
Primary completion: 2014-05-12
Completion: 2017-02-28

Publications

Huang X, Chau CH, Figg WD. Challenges to improved therapeutics for metastatic castrate resistant prostate cancer: from recent successes and failures. J Hematol Oncol. 2012 Jul 2;5:35. doi: 10.1186/1756-8722-5-35.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abiraterone acetate	Small molecule	500 mg	Oral
Subject	Abiraterone acetate	Small molecule	750 mg	Oral
Subject	Abiraterone acetate	Small molecule	1000 mg	Oral
Subject	Docetaxel	Small molecule	60 mg/m2	Intravenous
Subject	Docetaxel	Small molecule	75 mg/m2	Intravenous
Background	Prednisone	Other / unclassified	10 mg	Oral

A Safety Study of Abiraterone Acetate Administered in Combination With Docetaxel in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Summary

Timeline

Publications

Drugs

Indications