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| Sponsor: | Celgene Corporation |
|---|---|
| Information provided by (Responsible Party): | Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT00988208 |
Purpose
The purpose of the study is to determine whether lenalidomide is safe and effective for use in combination with docetaxel and prednisone for the treatment of subjects with metastatic Castrate-Resistant Prostate Cancer.
The addition of lenalidomide to docetaxel and prednisone is proposed to increase the life expectancy of these subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Castrate-Resistant Prostate Cancer |
Drug: Lenalidomide (CC-5013) 10mg, 15mg, 20mg, 25mg and their respective matching placebo capsules for oral administration |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
| Estimated Enrollment: | 1015 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | October 2017 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: DPL treatment arm
25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel IV on Day 1; 5 mg prednisone orally twice each day (BID) on each day of the treatment cycle
|
Drug: Lenalidomide (CC-5013) 10mg, 15mg, 20mg, 25mg and their respective matching placebo capsules for oral administration
DP treatment arm: Oral placebo once each day (QD) on Days 1-14 of the treatment cycle; 75 mg/m^2 docetaxel IV on Day 1; 5 mg prednisone orally twice each day (BID) on each day of the treatment cycle DPL treatment arm: 25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel IV on Day 1; 5 mg prednisone orally twice each day (BID) on each day of the treatment cycle Other Names:
|
|
Experimental: DP treatment arm
Oral placebo once each day (QD) on Days 1-14 of the treatment cycle; 75 mg/m^2 docetaxel IV on Day 1; 5 mg prednisone orally twice each day (BID) on each day of the treatment cycle
|
Drug: Lenalidomide (CC-5013) 10mg, 15mg, 20mg, 25mg and their respective matching placebo capsules for oral administration
DP treatment arm: Oral placebo once each day (QD) on Days 1-14 of the treatment cycle; 75 mg/m^2 docetaxel IV on Day 1; 5 mg prednisone orally twice each day (BID) on each day of the treatment cycle DPL treatment arm: 25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel IV on Day 1; 5 mg prednisone orally twice each day (BID) on each day of the treatment cycle Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 198 Study Locations| Study Director: | Debora Barton, MD | Celgene Corporation |
More Information
| Responsible Party: | Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT00988208 History of Changes |
| Other Study ID Numbers: | CC-5013-PC-002, EudraCT Number 2008-007969-23 |
| Study First Received: | October 1, 2009 |
| Last Updated: | May 14, 2012 |
| Health Authority: | United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration Austria: Federal Office for Safety in Health Care Belgium: Federal Agency for Medicinal Products and Health Products Canada: Health Canada Denmark: Danish Medicines Agency France: Afssaps - French Health Products Safety Agency Germany: Federal Institute for Drugs and Medical Devices Italy: The Italian Medicines Agency Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products United Kingdom: Medicines and Healthcare Products Regulatory Agency Hungary: National Institute of Pharmacy Israel: Ministry of Health Czech Republic: State Institute for Drug Control Russia: Ministry of Health and Social Development of the Russian Federation South Africa: Medicines Control Council Spain: Agencia Española de Medicamentos y Productos Sanitarios Brazil: National Health Surveillance Agency Mexico: Federal Commission for Sanitary Risks Protection Greece: National Organization of Medicines Sweden: Medical Products Agency |
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Castrate-Resistant Prostate Cancer Revlimid Lenalidomide |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Prednisone Docetaxel Lenalidomide Thalidomide Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anti-Inflammatory Agents Immunosuppressive Agents Immunologic Factors Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |