CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 159 enrolled
Drug / intervention
Abiraterone Acetate +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01576172
NCT01576172Phase 2Completed

A Randomized Gene Fusion Stratified Phase 2 Trial of Abiraterone With or Without ABT-888 for Patients With Metastatic Castration-Resistant Prostate Cancer

National Cancer Institute (NCI)·interventional·Posted Apr 12, 2012·Updated Nov 12, 2020

In Brief

A Phase 2 clinical trial evaluating Abiraterone Acetate, Laboratory Biomarker Analysis, and 2 other interventions for Castration-Resistant Prostate Carcinoma and 2 related conditions. Completed, enrolled 159 participants across 14 sites.

Detailed Summary

This randomized phase II trial studies abiraterone acetate and prednisone together with veliparib to see how well it works compared to abiraterone acetate and prednisone alone in treating patients with castration-resistant prostate cancer that has spread from the primary site to other places in the body. Androgens can cause the growth of prostate cancer cells. Antiandrogen drugs, such as abiraterone acetate, may lessen the amount of androgens made by the body. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving abiraterone acetate together with prednisone and veliparib may work better than abiraterone acetate and prednisone alone in treating patients with castration-resistant prostate cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 12, 2012
Enrollment StartMar 30, 2012
Primary CompletionOct 23, 2019
Study CompletionApr 23, 2020
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 14.2 years ago

Interventions

Abiraterone Acetatedrug

Given PO

Laboratory Biomarker Analysisother

Correlative studies

Prednisonedrug

Given PO

Veliparibdrug

Given PO