CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
Abiraterone +1 moredrug
Likely dose
Abiraterone 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/NCT01424930
NCT01424930Phase 2Completed
CompareCT.gov

An Open-Label Study to Determine the Short-Term Safety of Continuous Dosing of Abiraterone Acetate and Prednisone in Modified Fasting and Fed States to Subjects With Metastatic Castration-Resistant Prostate Cancer

Janssen-Ortho Inc., Canada·interventional·Posted Aug 29, 2011·Updated Jul 25, 2014

In Brief

A Phase 2 clinical trial evaluating Abiraterone and Prednisone for Prostate Neoplasms and Prostate Cancer. Completed, enrolled 25 participants across 2 sites.

Detailed Summary

The purpose of this study is to establish the safety profile of oral (by mouth) abiraterone acetate and oral prednisone following short-term administration after standardized low-fat or high-fat meals to patients with metastatic (spreading) castration-resistant prostate cancer (mCRPC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Neoplasms, Prostate Cancer
CountriesCanada
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 29, 2011
Enrollment StartOct 1, 2011
Primary CompletionApr 1, 2013
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 14.8 years ago

Interventions

Abirateronedrug

Participants will receive abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized low-fat meal and high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14.

Prednisonedrug

Prednisone will be administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.