CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
enzalutamide +2 moredrug
Likely dose
enzalutamide 160 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/NCT01650194
NCT01650194Phase 2Completed
CompareCT.gov

A Phase 2 Study Determining Safety and Tolerability of Enzalutamide (Formerly MDV3100) in Combination With Abiraterone Acetate in Bone Metastatic Castration-Resistant Prostate Cancer Patients

Astellas Pharma Global Development, Inc.·interventional·Posted Jul 26, 2012·Updated Dec 10, 2024

In Brief

A Phase 2 clinical trial evaluating enzalutamide, abiraterone acetate, and 1 other intervention for Metastatic Castration-Resistant Prostate Cancer. Completed, enrolled 60 participants across 1 site.

Detailed Summary

The purpose of this study was to explore the safety and tolerability of enzalutamide in combination with abiraterone acetate plus prednisone. Subjects diagnosed with cancer of the prostate that was getting worse and spreading to the bone despite receiving hormone treatment were enrolled and received study treatment until disease progression.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Castration-Resistant Prostate Cancer
CountriesUnited States
CollaboratorsMedivation LLC, a wholly owned subsidiary of Pfizer Inc.

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 26, 2012
Enrollment StartJul 9, 2012
Primary CompletionJan 4, 2018
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 13.9 years ago

Interventions

enzalutamidedrug

Participants received 160 mg of enzalutamide orally once daily (4 capsules, 40 mg each).

abiraterone acetatedrug

Participants received 1000 mg of abiraterone acetate orally once daily (4 tablets, 250 mg each).

prednisonedrug

Participants received 5 mg of prednisone orally twice daily (2 tablets, 5 mg each).