Abiraterone Acetate Dose-Escalation Study in Hormone Refractory Prostate Cancer

Phase 1/2 Completed 66 enrolled Janssen Research & Development, LLC

Non-randomizedSingle-groupOpen-labelTreatment

Summary

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).

Timeline

Start: 2006-06
Primary completion: 2012-12
Completion: 2012-12

Publications

Aggarwal R, Harris A, Formaker C, Small EJ, Molina A, Griffin TW, Ryan CJ. Response to subsequent docetaxel in a patient cohort with metastatic castration-resistant prostate cancer after abiraterone acetate treatment. Clin Genitourin Cancer. 2014 Oct;12(5):e167-72. doi: 10.1016/j.clgc.2014.03.010. Epub 2014 Mar 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abiraterone acetate	Small molecule	250 mg	Oral
Subject	Abiraterone acetate	Small molecule	500 mg	Oral
Subject	Abiraterone acetate	Small molecule	750 mg	Oral
Subject	Abiraterone acetate	Small molecule	1000 mg	Oral
Background	Dexamethasone	Small molecule	0.5 mg	—
Background	Prednisolone	Other / unclassified	5 mg	—
Background	Prednisone	Other / unclassified	5 mg	—

Abiraterone Acetate Dose-Escalation Study in Hormone Refractory Prostate Cancer

Summary

Timeline

Publications

Drugs

Indications