A Phase 3 Study to Evaluate the Efficacy and Safety of Docetaxel and Prednisone with or without Lenalidomide in Subjects with Castrate-Resistant Prostate Cancer (CRPC)
Phase 1
- Conditions
- Chemo-naive metastatic prostate cancer subjects with documented rising Prostate Specific Antigen (PSA) or documented Progressive Disease (PD) following hormonal therapy.MedDRA version: 14.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2008-007969-23-IT
- Lead Sponsor
- Celgene Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 1059
Inclusion Criteria
Screening and recruitment was completed under protocol amendment 2
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 317
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 742
Exclusion Criteria
Screening and recruitment was completed under protocol amendment 2
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method