Status:
COMPLETED
Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer
Lead Sponsor:
Celgene
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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-Resistan...
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 w...
Eligibility Criteria
Inclusion
- Must sign an Informed Consent Form (ICF)
- Males ≥ 18 years of age
- Able to adhere to the study visit schedule and requirements of the protocol
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Life expectancy of ≥ 12 weeks
- Willingness to participate in Patient-Reported Outcomes assessments
- Serum testosterone levels \< 50 ng/dL
- Confirmed metastatic adenocarcinoma of the prostate that is unresponsive or refractory to hormonal therapy
- Have documented disease progression while receiving or following hormonal therapy as determined by increasing Serum Prostate Specific Antigen (PSA) level, Radiological Progression, or ≥2 new bone lesions
- Subjects must agree to receive counseling related to pregnancy precautions, teratogenic and other risks of lenalidomide
- Refrain from donating blood or semen as defined by protocol
Exclusion
- A history of clinically significant disease that places subject at an unacceptable risk for study entry
- Prior Therapy with thalidomide, lenalidomide or pomalidomide
- Prior chemotherapy for prostate cancer
- Use of any other experimental drug or therapy within 28 days prior to randomization
- Prior radiation to ≥ 30% of bone marrow or any radiation therapy within 28 days prior to randomization
- Prior use of Strontium-89 at any time or Samarium-153 within 56 days prior to randomization
- Surgery within 28 days prior to randomization
- Concurrent anti-androgen therapy
- Abnormal serum chemistry or hematology laboratory values
- Significant active cardiac disease within the previous 6 months:
- Thrombotic or thromboembolic events within the past 6 months:
- History of peripheral neuropathy of ≥grade 2
- History of severe hypersensitivity reaction to drugs formulated with polysorbate 80
- Paraplegia
- History of Central nervous system (CNS) or brain metastases
- History of malignancies other than prostate cancer within the past 5 years, with the exception of treated basal cell/squamous cell carcinoma of the skin
- Concurrent use of alternative cancer therapies
Key Trial Info
Start Date :
November 11 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2016
Estimated Enrollment :
1059 Patients enrolled
Trial Details
Trial ID
NCT00988208
Start Date
November 11 2009
End Date
November 28 2016
Last Update
April 4 2018
Active Locations (210)
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1
Hematology Oncology Associates
Phoenix, Arizona, United States, 85012
2
Northern AZ Hematology and Oncology Assoc
Sedona, Arizona, United States, 86336
3
Arizona Oncology
Tucson, Arizona, United States, 85710
4
City of Hope Cancer Center
Duarte, California, United States, 91010-3000