A study of patients with prostate cancer who have previously been treated with docetaxel-based chemotherapy, where patients receive either study drug or placebo
- Conditions
- Patients with progressive castration-resistant prostate cancer previously treated with docetaxel-based chemotherapyMedDRA version: 19.0Level: 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-DE
- Lead Sponsor
- Medivation, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 1199
-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.
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
-Metastases in the brain or active epidural disease;
-Another malignancy within the previous 5 years;
-Clinically significant cardiovascular disease;
-Gastrointestinal disorder affecting absorption.
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.