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

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.

Inclusion criteria

• 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 criteria

• 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