Trial intelligence / Profile preview

Abiraterone Acetate and Prednisone in Post-Docetaxel Advanced Prostate Cancer

NCT00485303Phase 2

Key facts

Status: Completed
Start: Jun 2007
Primary completion: Oct 2011
Countries: 2
Sponsor: Cougar Biotechnology
Modality: Small Molecules

Drugs: Abiraterone Acetate Tablets (I)
Conditions: prostate cancer (PCa)

Overview

Phase 2, open-label, single-arm trial of Abiraterone Acetate Tablets (I) in prostate cancer (PCa), sponsored by Cougar Biotechnology. Primary endpoint: Percentage of Participants With Prostate Specific Antigen (PSA) Response. Started Jun 2007; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Abiraterone + Prednisone
Abiraterone acetate 1000 mg daily + Prednisone 5 mg twice daily

Who it enrols

Patients with histologically confirmed adenocarcinoma of the prostate who have failed androgen deprivation and docetaxel-based chemotherapy, with PSA progression and castrate testosterone levels.

Endpoints

Primary

Percentage of Participants With Prostate Specific Antigen (PSA) ResponseDay 1 of each cycle up to Cycle 12

Secondary

Prostate-Specific Antigen Based Progression-free SurvivalUp to 60 months
Radiographic Progression Free SurvivalUp to 60 months
Overall SurvivalUp to 60 months
Percentage of Participants With Objective Radiographic ResponseUp to 60 months
Time to PSA ProgressionUp to 60 months
Time to Radiographic ProgressionUp to 60 months
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status ScoreUp to 60 months
Percentage of Participants With Clinical BenefitUp to 60 months

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