Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer
Information source: Celgene Corporation
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Castrate-Resistant Prostate Cancer
Intervention: Lenalidomide (CC-5013) 10mg, 15mg, 20mg, 25mg and their respective matching placebo capsules for oral administration (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Celgene Corporation Official(s) and/or principal investigator(s):
Mark Jones, MD, Study Director, Affiliation: Celgene Corporation
Overall contact:
Brian A Tozzi, MS, Phone: +1-908-673-9550, Email: mainsail@celgene.com
Summary
The purpose of the study is to determine whether lenalidomide is safe and effective 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.
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Primary outcome: Overall Survival
Secondary outcome: Progression-Free Survival (PFS)Objective Response Rate Safety of lenalidomide in combination with docetaxel and prednisone
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
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. 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 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
Exclusion Criteria:
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 whole pelvic radiation therapy 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 corticosteroid or hormonal 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
Locations and Contacts
Brian A Tozzi, MS, Phone: +1-908-673-9550, Email: mainsail@celgene.com Additional Information
Starting date: November 2009
Ending date: October 2017
Last updated: October 1, 2009
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