CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
Abiraterone Acetate +1 moredrug
Likely dose
Abiraterone Acetate 1,000 mgfrom 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/NCT01637402
NCT01637402Phase 2Completed
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A Phase II Study of Increased-Dose Abiraterone Acetate in Patients With Castration Resistant Prostate Cancer (CRPC)

Terence Friedlander, MD·interventional·Posted Jul 11, 2012·Updated Aug 17, 2020

In Brief

A Phase 2 clinical trial evaluating Abiraterone Acetate and Prednisone for Castration Resistant Prostate Cancer. Completed, enrolled 41 participants across 2 sites.

Detailed Summary

The purpose of this study is to find out what effects, good and/or bad,an increased dose of Abiraterone Acetate in combination with prednisone has on patients and their prostate cancer. This study will investigate whether an increased-dose (2,000mg daily) is safe and potentially effective when given to patients whose cancer has grown while taking the standard dose.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCastration Resistant Prostate Cancer
CountriesUnited States
CollaboratorsJanssen Biotech, Inc.

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 11, 2012
Enrollment StartMar 13, 2013
Primary CompletionFeb 27, 2017
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 14.0 years ago

Interventions

Abiraterone Acetatedrug

Standard dose participants: 1,000 mg, once daily, oral administration. Dose escalation participants: 1,000 mg, twice daily, oral administration

Prednisonedrug

5 mg, twice daily, oral administration