NCT00988208

Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,059 (actual)
• Sponsor: Celgene · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

In November 2011, the Data Monitoring Committee concluded it was unlikely that the study would meet its primary endpoint of overall survival (OS) and recommended that the study be stopped. The study was terminated in accordance with this recommendation. All sites were instructed to immediately discontinue all patients from experimental lenalidomide/placebo treatment administered either in combination with chemotherapy or as a single agent following chemotherapy discontinuation. Subsequently, Protocol Amendment 3 was issued to provide for the following: To continue to collect information on Second Primary Malignancies (SPMs) and additional treatments for Prostate Cancer in all randomized subjects during survival follow-up. To continue to provide docetaxel and prednisone for up to 10 cycles to subjects randomized at non-US sites who were ongoing in the CC-5013-PC-002 protocol when the decision was made to discontinue lenalidomide/placebo and who were experiencing benefit as per investigator discretion. For subjects who had exceeded 10 cycles of docetaxel and prednisone at the time of Protocol Amendment 3 approval, an additional two cycles were provided. All references to dosing and study procedures pertaining to the safety, efficacy, and exploratory endpoints of lenalidomide/placebo were discontinued as part of Protocol Amendment 3.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Lenalidomide	25 mg lenalidomide orally once each day on Days 1-14
DRUG	Docetaxel	75 mg/m2 intravenous docetaxel on Day 1
DRUG	Prednisone	5 mg prednisone orally twice daily on each day of the treatment cycle
DRUG	Placebo	Oral placebo once each day on Days 1-14 of the treatment cycle

Timeline

• Start date: 2009-11-11
• Primary completion: 2012-01-13
• Completion: 2016-11-28
• First posted: 2009-10-02
• Last updated: 2018-04-04
• Results posted: 2013-09-05

Locations

210 sites across 21 countries: United States, Australia, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Mexico, Netherlands, Poland, Russia, South Africa, Spain, Sweden, United Kingdom