CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,059 enrolled
Drug / intervention
Lenalidomide +3 moredrug
Likely dose
Lenalidomide 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00988208
NCT00988208Phase 3Completed
CompareCT.gov

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)

Celgene·interventional·Posted Oct 2, 2009·Updated Apr 4, 2018

In Brief

A Phase 3 clinical trial evaluating Lenalidomide, Docetaxel, and 2 other interventions for Prostate Cancer. Completed, enrolled 1,059 participants across 210 sites in 21 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesAustralia, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Mexico, Netherlands, Poland, Russia, South Africa, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2, 2009
Enrollment StartNov 11, 2009
Primary CompletionJan 13, 2012
Study CompletionNov 28, 2016
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 16.8 years ago

Interventions

Lenalidomidedrug

25 mg lenalidomide orally once each day on Days 1-14

Docetaxeldrug

75 mg/m2 intravenous docetaxel on Day 1

Prednisonedrug

5 mg prednisone orally twice daily on each day of the treatment cycle

Placebodrug

Oral placebo once each day on Days 1-14 of the treatment cycle