Overview

This trial is active, not recruiting.

Condition castration-resistant prostate cancer
Treatments enzalutamide, placebo
Phase phase 3
Target androgen receptor
Sponsor Medivation, Inc.
Collaborator Astellas Pharma Inc
Start date September 2009
End date November 2011
Trial size 1199 participants
Trial identifier NCT00974311, CRPC2

Summary

This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Formerly MDV3100
enzalutamide Formerly MDV3100
MDV3100, 160 mg orally per day
(Placebo Comparator)
placebo
Placebo comparator

Primary Outcomes

Measure
Overall Survival
time frame: During study period (up to 3 years)

Secondary Outcomes

Measure
Radiographic Progression-free Survival
time frame: During study period (up to 3 years)
Time to First Skeletal-related Event
time frame: During study period (up to 3 years)
Functional Assessment of Cancer Therapy - Prostate (FACT-P)
time frame: During study period (up to 3 years)
Time to Prostate-specific Antigen (PSA) Progression
time frame: Baseline and at every study visit from week 13 while on study drug (up to 3 years)
Percentage of Patients With Pain Palliation
time frame: During study period (up to 3 years)
Percentage of Patients With Prostate Specific Antigen (PSA) Response
time frame: During study period (up to 3 years)
Percentage of Patients With Soft-tissue Objective Response
time frame: During study period (up to 3 years)
European Quality of Life Five-Domain Scale (EQ-5D)
time frame: At Week 13 visit
Circulating Tumor Cell (CTC) Conversion Rate
time frame: During study period (up to 3 years)

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - Progressive prostate cancer - Medical or surgical castration with testosterone less than 50 ng/dl - One or two prior chemotherapy regimens. At least one chemotherapy regimen must have contained docetaxel - ECOG performance status 0-2 - Adequate bone marrow, hepatic, and renal function - Able to swallow the study drug and comply with study requirements - Informed consent Exclusion Criteria: - Metastases in the brain or active epidural disease - Another malignancy within the previous 5 years - Clinically significant cardiovascular disease - GI disorder affecting absorption

Additional Information

Official title AFFIRM: A Multinational Phase 3, Randomized, Double-Blind, Placebo-COntrolled Efficacy and Safety Study of Oral MDV3100 in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Medivation, Inc..