At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 66 enrolled

Drug / intervention

Abiraterone acetate +2 moredrug

Likely dose

Abiraterone acetate 250 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/NCT00473746

NCT00473746Phase 2Completed

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Phase I/II Open Label Dose Escalation Study of the 17α-Hydroxylase/ C17,20-Lyase Inhibitor, Abiraterone Acetate in Hormone Refractory Prostate Cancer

Janssen Research & Development, LLC·interventional·Posted May 15, 2007·Updated Apr 29, 2014

In Brief

A Phase 2 clinical trial evaluating Abiraterone acetate and prednisone/prednisolone or dexamethasone for Prostate Neoplasms. Completed, enrolled 66 participants across 3 sites.

Detailed Summary

The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and anti-tumor activities of abiraterone acetate (also referred to as CB7630) in patients with hormone refractory prostate cancer (HRPC).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsProstate Neoplasms

CountriesUnited States

Collaborators--

Timeline

Phase 2CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJun 2006

First PostedMay 2007

Primary CompletionDec 2012

TodayJul 2026

First PostedMay 15, 2007

Enrollment StartJun 1, 2006

Primary CompletionDec 1, 2012

TodayJul 2, 2026

Enrollment to primary: 6.5 yearsPosted 19.1 years ago

Interventions

Abiraterone acetatedrug

The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000mg/day until Maximum Tolerated Dose (MTD) and a recommended Phase II dose was established.

Abiraterone acetatedrug

Abiraterone acetate 1000 mg daily under fasted conditions upto 10 cycles of therapy.

prednisone/prednisolone or dexamethasonedrug

prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) concurrent with abiraterone acetate