CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 82 enrolled
Drug / intervention
Abiraterone acetate +1 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/NCT01685983
NCT01685983Phase 2Completed
CompareCT.gov

A Phase 2 Open Label Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy.

Janssen Research & Development, LLC·interventional·Posted Sep 17, 2012·Updated Mar 15, 2019

In Brief

A Phase 2 clinical trial evaluating Abiraterone acetate and Prednisolone for Prostate Cancer. Completed, enrolled 82 participants across 8 sites in 2 countries.

Detailed Summary

The purpose of this study is to assess the safety and efficacy in Korea or Taiwan of oral abiraterone acetate and oral prednisolone in men with metastatic-castration resistant prostate cancer (mCRPC) and with disease progression following treatment with a docetaxel-containing chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesSouth Korea, Taiwan
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 17, 2012
Enrollment StartAug 30, 2011
Primary CompletionJan 24, 2013
Study CompletionMar 6, 2018
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 13.8 years ago

Interventions

Abiraterone acetatedrug

Type=exact number, unit=mg, number=250, form=tablet, route=oral. Patients will receive 4 tablets of abiraterone acetate at least 1 hour before a meal or 2 hours after a meal any time up to 10 pm every day.

Prednisolonedrug

Type=exact number, unit=mg, number=5, form=tablet, route=oral. Patients will receive 1 tablet of prednisolone twice daily.