A Study to Determine Safety and Tolerability of Enzalutamide (MDV3100) in Combination With Abiraterone Acetate in Bone Metastatic Castration-Resistant Prostate Cancer Patients

Phase 2 Completed 60 enrolled Astellas Pharma Global Development, Inc. Medivation LLC, a wholly owned subsidiary of Pfizer Inc. · collab

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2012-07-09
Primary completion: 2018-01-04
Completion: 2018-01-04

Publications

Assi R, Temraz S, Shamseddine A, Mukherji D. New Compounds Targeting the Androgen Receptor for Treatment of Advanced Prostate Cancer. Curr Drug Targets. 2016;17(3):290-302. doi: 10.2174/1389450116666150907101044.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Enzalutamide	Other / unclassified	160 mg	Oral
Background	Abiraterone acetate	Small molecule	1000 mg	Oral
Background	Prednisone	Other / unclassified	5 mg	Oral

A Study to Determine Safety and Tolerability of Enzalutamide (MDV3100) in Combination With Abiraterone Acetate in Bone Metastatic Castration-Resistant Prostate Cancer Patients

Summary

Timeline

Publications

Drugs

Indications