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

NCT00988208 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1059

Last updated 2018-04-04

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Debora Barton, MD · Celgene Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-11
Primary Completion
2012-01-13
Completion
2016-11-28

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

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00988208 on ClinicalTrials.gov