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

Completed · Phase 3 · Has a placebo group

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00988208

Run by

Celgene

People needed

1059

Starts

2009-11-11

Expected to finish

2016-11-28

Last updated by the study team

2018-04-04

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Northern AZ Hematology and Oncology Assoc — Sedona, Arizona, United States
• Arizona Oncology — Tucson, Arizona, United States
• City of Hope Cancer Center — Duarte, California, United States
• Southwest Cancer Center - Escondido — Escondido, California, United States
• Scripps Cancer Center - Clinical Research — La Jolla, California, United States
• VA Long Beach Healthcare System — Long Beach, California, United States
• The Angeles Clinc and Research Institute — Los Angeles, California, United States
• University of Southern California — Los Angeles, California, United States
• Prostate Oncology Specialists — Marina del Rey, California, United States
• Stanford University Medical Center — Stanford, California, United States
• Rocky Mountain Cancer Centers-Colorado Springs Circle — Colorado Springs, Colorado, United States
• Washington Cancer Institute — Washington D.C., District of Columbia, United States
• Melbourne Internal Medicine Associates — Melbourne, Florida, United States
• Advanced Medical Specialties — Miami, Florida, United States
• Florida Cancer Institute - New Hope — New Port Richey, Florida, United States
• Ocala Oncology Center — Ocala, Florida, United States
• Cancer Centers of Florida, P.A.- West Gore Street — Orlando, Florida, United States
• South Florida Oncology - Hematology — Tamarac, Florida, United States
• Palm Beach Cancer Institute, LLC — West Palm Beach, Florida, United States
• Cancer Care and Hematology Specialists of Chicagoland — Niles, Illinois, United States
• Lutheran General Hospital — Park Ridge, Illinois, United States
• Indiana University Health — Indianapolis, Indiana, United States
• Hematology and Oncology Specialist, LLC — Metairie, Louisiana, United States
• Maryland Oncology Hematology PA — Columbia, Maryland, United States
• Hematology Oncology Associates — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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