Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer
Trial ID or NCT#
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.
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)
- 1. Must sign an Informed Consent Form (ICF) 2. Males ≥ 18 years of age 3. Able to adhere to the study visit schedule and requirements of the protocol 4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 5. Life expectancy of ≥ 12 weeks 6. Willingness to participate in Patient-Reported Outcomes assessments 7. Serum testosterone levels < 50 ng/dL 8. Confirmed metastatic adenocarcinoma of the prostate that is unresponsive or refractory to hormonal therapy 9. 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 10. Subjects must agree to receive counseling related to pregnancy precautions, teratogenic and other risks of lenalidomide 11. Refrain from donating blood or semen as defined by protocol
- 1. A history of clinically significant disease that places subject at an unacceptable risk for study entry 2. Prior Therapy with thalidomide, lenalidomide or pomalidomide 3. Prior chemotherapy for prostate cancer 4. Use of any other experimental drug or therapy within 28 days prior to randomization 5. Prior radiation to ≥ 30% of bone marrow or any radiation therapy within 28 days prior to randomization 6. Prior use of Strontium-89 at any time or Samarium-153 within 56 days prior to randomization 7. Surgery within 28 days prior to randomization 8. Concurrent anti-androgen therapy 9. Abnormal serum chemistry or hematology laboratory values 10. Significant active cardiac disease within the previous 6 months: 11. Thrombotic or thromboembolic events within the past 6 months: 12. History of peripheral neuropathy of ≥grade 2 13. History of severe hypersensitivity reaction to drugs formulated with polysorbate 80 14. Paraplegia 15. History of Central nervous system (CNS) or brain metastases 16. 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 17. Concurrent use of alternative cancer therapies
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