A study of patients with prostate cancer who have previously beentreated with docetaxel-based chemotherapy, where patients receiveeither study drug or placebo

Phase 1

• Conditions: Patients with progressive castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy; MedDRA version: 16.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-013174-41-AT
• Lead Sponsor: Medivation, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-03
• Last Update Posted: 29 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 1199

Inclusion Criteria

-Progressive prostate cancer;
-One or two prior chemotherapy regimens. At least one chemotherapy regimen must have contained docetaxel;
-Medical or surgical castration with a testosterone level < 1.7 nmol/L (50 ng/dL);
-ECOG performance status of 0-2;
-Adequate bone marrow, hepatic, and renal function;
-Able to swallow the study drug and comply with study requirements;
-Willing and able to give informed consent.
Open-Label Extension Criteria for Patients Randomized to the Placebo
Arm Patients randomized to the placebo arm of the blinded portion of
the study must meet the following inclusion criteria:
-Willing and able to give informed consent;
-No more than a total of two prior chemotherapy regimens;
-ECOG performance status of 0–2;
-Able to swallow the study drug and comply with study requirements;
Open-Label Extension Eligibility Criteria for Patients Continuing
MDV3100 Patients continuing MDV3100 must meet the following
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eligibility criterion:
-Willing and able to give informed consent for open-label extension
period.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 359
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 840

Exclusion Criteria

-Metastases in the brain or active epidural disease;
-Another malignancy within the previous 5 years;
-Clinically significant cardiovascular disease;
-Gastrointestinal disorder affecting absorption.
Open-Label Extension Criteria for Patients Randomized to the Placebo
Arm
Patients randomized to the placebo arm of the blinded portion of the
study must NOT meet any of the following exclusion criteria:
-Known or suspected brain metastasis;
-Clinically significant cardiovascular disease including

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • To determine the benefit of MDV3100 as compared to placebo as assessed by overall survival.;Secondary Objective: Not Applicable.;Primary end point(s): The primary efficacy outcome is a comparison of overall survival between the MDV3100-treated and the placebo groups.;Timepoint(s) of evaluation of this end point: When the required number of deaths have occurred as specified in the protocol.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable.