NCT01650194

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

For the study duration, all subjects maintained androgen deprivation with a gonadotropin releasing hormone (GnRH) agonist or antagonist or orchiectomy. Study drug was administered until disease progression. Disease progression was defined as a composite endpoint consisting of either clinical deterioration, radiographic progression or prostate-specific antigen (PSA) progression according to the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria.

Conditions

• Metastatic Castration-Resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	enzalutamide	Participants received 160 mg of enzalutamide orally once daily (4 capsules, 40 mg each).
DRUG	abiraterone acetate	Participants received 1000 mg of abiraterone acetate orally once daily (4 tablets, 250 mg each).
DRUG	prednisone	Participants received 5 mg of prednisone orally twice daily (2 tablets, 5 mg each).

Timeline

• Start date: 2012-07-09
• Primary completion: 2018-01-04
• Completion: 2018-01-04
• First posted: 2012-07-26
• Last updated: 2024-12-10
• Results posted: 2019-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study