Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy - Tabular View

Tracking Information

First Received Date ^ICMJE

March 13, 2008

Last Updated Date

May 11, 2009

Start Date ^ICMJE

April 2008

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Overall Survival [ Time Frame: During the Study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00638690 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Proportion of patients achieving a PSA decline ≥ 50% according to Prostate Specific Antigen Working Group (PSAWG) criteria [ Time Frame: During Study Treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

Official Title ^ICMJE

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Metastatic Castration-Resistant Prostate Cancer

Intervention ^ICMJE

Drug: placebo plus prednisone/prednisolone
Drug: abiraterone acetate plus prednisone/prednisolone

Study Arms / Comparison Groups

Experimental: abiraterone acetate plus prednisone/prednisolone
Placebo Comparator: placebo plus prednisone/prednisolone

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

1158

Estimated Completion Date

June 2011

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Major Inclusion Criteria:

Metastatic Castration-Resistant Prostate Cancer
Progression after one or two prior cytotoxic chemotherapies. At least one chemotherapy must have contained docetaxel
ECOG Performance Status less than/ equal to 2
Medical or surgical castration with testosterone less than 50 ng/dL
Adequate bone marrow, hepatic and renal function
Potassium greater than/ equal to 3.5 mmol/L
Able to swallow the study drug whole as a tablet
Informed Consent

Major Exclusion Criteria:

More than two prior cytotoxic chemotherapy regimens
Prior Ketoconazole for prostate cancer
Prior Abiraterone acetate or other CYP17 inhibitor or investigational agents targeting the androgen receptor for prostate cancer
Uncontrolled hypertension
Active or symptomatic viral hepatitis or chronic liver disease
History of pituitary or adrenal dysfunction
Clinically significant heart disease
Other malignancy
Known brain metastasis
GI disorder affecting absorption
Not willing to use contraception

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Austria, Belgium, Canada, France, Germany, Hungary, Ireland, Italy, Netherlands, Spain, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00638690

Responsible Party

Christopher M. Haqq MD PhD, Cougar Biotechnology, Inc.

Study ID Numbers ^ICMJE

COU-AA-301

Study Sponsor ^ICMJE

Cougar Biotechnology, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:	Howard I Scher, MD	Memorial Sloan-Kettering Cancer Center
Study Chair:	JS de Bono, MD FRCP PhD	ICR/Royal Marsden Hospital

Information Provided By

Cougar Biotechnology, Inc.

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP