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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

Phase 3
18 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

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

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:

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

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 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

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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Description:

Number of participants who survive

Outcome Time Frame:

Cycle 1 Day 1 until subject death

Safety Issue:


Principal Investigator

Debora Barton, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation


United States: Food and Drug Administration

Study ID:




Start Date:

November 2009

Completion Date:

November 2016

Related Keywords:

  • Prostate Cancer
  • Castrate-Resistant Prostate Cancer
  • Revlimid
  • Lenalidomide
  • Prostatic Neoplasms



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