Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments enzalutamide, abiraterone, placebo for enzalutamide, prednisone
Phase phase 4
Target androgen receptor
Sponsor Medivation, Inc.
Collaborator Astellas Pharma Inc
Start date November 2013
End date December 2016
Trial size 509 participants
Trial identifier NCT01995513, MDV3100-10

Summary

The purpose of this study is to determine if continued treatment with Enzalutamide is effective in patients with metastatic prostate cancer.

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, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with abiraterone (1000 mg) administered as four 250-mg tablets by mouth once daily and prednisone (10 mg) administered as one 5-mg tablet by mouth twice daily
enzalutamide MDV3100
160 mg by mouth once daily
abiraterone Abiraterone acetate
1000 mg by mouth once daily
prednisone prednisolone
5 mg by mouth twice daily
(Active Comparator)
Enzalutamide placebo (placebo) capsules (identical in appearance to enzalutamide) administered as 4 capsules by mouth once daily in combination with abiraterone (1000 mg) administered as four 250-mg tablets by mouth once daily and prednisone (10 mg) administered as one 5-mg tablet by mouth twice daily.
abiraterone Abiraterone acetate
1000 mg by mouth once daily
placebo for enzalutamide
Sugar pill manufactured to mimic Enzalutamide 40 mg capsule
prednisone prednisolone
5 mg by mouth twice daily

Primary Outcomes

Measure
Progression Free Survival (PFS)
time frame: Every two months following randomization for up to 50 months

Secondary Outcomes

Measure
Time to PSA Progression
time frame: Every two months following randomization for up to 50 months
PSA Response
time frame: Every two months following randomization for up to 50 months
Objective Response Rate (ORR)
time frame: Every two months following randomization for up to 50 months
Rate of pain progression
time frame: Every two months following randomization for up to 50 months
Time to first use of subsequent antineoplastic therapy for prostate cancer
time frame: Every two months following randomization for up to 50 months
Quality of life as assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P)
time frame: Every two months following randomization for up to 50 months
Safety as assessed by percentage of patients with any Adverse Event (AE), AE leading to Study Drug Discontinuation, AE leading to death, Serious Adverse Event (SAE), AE related to study drug, SAE related to study drug
time frame: Every two months following randomization for up to 50 months

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - Men with metastatic castration-resistant prostate cancer - Progressive disease on androgen deprivation therapy - Patients must agree to continue androgen deprivation therapy with a GnRH agonist/antagonist throughout the study or have had a prior bilateral orchiectomy - ECOG performance score ≤ 1 - Estimated life expectancy of ≥ 12 months Exclusion Criteria: - Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone, or enzalutamide for the treatment of prostate cancer - Prior participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless the treatment was placebo) - History of brain metastasis, active leptomeningeal disease or seizure - Severe cardiovascular or hepatic disease - Pituitary or adrenal dysfunction

Additional Information

Official title A Phase 4, Randomized, Double-Blind, Placebo-Controlled Study of Continued Enzalutamide Treatment Beyond Progression in Patients With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Medivation, Inc..