The evaluation of lenalidomide, with or without Docetaxel plus Prednisone, in the treatment of prostate cancer, when the cancer does not respond to hormonal treatment
Phase 1
- Conditions
- Chemo-naïve metastatic prostate cancer subjects with documented rising Prostate Specific Antigen (PSA) or documented Progressive Disease (PD) following hormonal therapyMedDRA version: 16.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2008-007969-23-GB
- Lead Sponsor
- Celgene Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- 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