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An Efficacy and Safety Study of Abiraterone Acetate and Prednisone in Participants With Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy

NCT00485303 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2013-07-02

Study results available
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Summary

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).

Conditions

Interventions

DRUG

Abiraterone acetate

Abiraterone acetate oral tablets 250 milligram (mg) each will be administered at a total dose of 1000 mg until documented disease progression or unacceptable toxicity.

DRUG

Prednisone

Prednisone/Prednisolone 5 mg tablet will be taken orally twice daily.

Sponsors & Collaborators

  • Cougar Biotechnology, Inc.

    lead INDUSTRY

Principal Investigators

  • Cougar Biotechnology, Inc. Clinical Trial · Cougar Biotechnology, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00485303 on ClinicalTrials.gov