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Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer (Mainsail)
This study is ongoing, but not recruiting participants.

First Received on October 1, 2009.   Last Updated on May 14, 2012   History of Changes
Sponsor: Celgene Corporation
Information provided by (Responsible Party): Celgene Corporation
ClinicalTrials.gov Identifier: NCT00988208
  Purpose

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.


Condition Intervention Phase
Castrate-Resistant Prostate Cancer
Drug: Lenalidomide (CC-5013) 10mg, 15mg, 20mg, 25mg and their respective matching placebo capsules for oral administration
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Cycle 1 Day 1 until subject death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: Cycle 1 day 1 until disease progression ] [ Designated as safety issue: No ]
  • Objective Response Rate [ Time Frame: Cycle 1 day 1 until best measurable response ] [ Designated as safety issue: No ]
  • Safety of lenalidomide in combination with docetaxel and prednisone [ Time Frame: baseline until 28 days after last study dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1015
Study Start Date: November 2009
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DPL treatment arm
25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel IV on Day 1; 5 mg prednisone orally twice each day (BID) on each day of the treatment cycle
Drug: Lenalidomide (CC-5013) 10mg, 15mg, 20mg, 25mg and their respective matching placebo capsules for oral administration

DP treatment arm: Oral placebo once each day (QD) on Days 1-14 of the treatment cycle; 75 mg/m^2 docetaxel IV on Day 1; 5 mg prednisone orally twice each day (BID) on each day of the treatment cycle

DPL treatment arm: 25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel IV on Day 1; 5 mg prednisone orally twice each day (BID) on each day of the treatment cycle

Other Names:
  • Lenalidomide: Revlimid
  • Docetaxel: Taxotere
  • Prednisone: there are multiple brand names for prednisone
Experimental: DP treatment arm
Oral placebo once each day (QD) on Days 1-14 of the treatment cycle; 75 mg/m^2 docetaxel IV on Day 1; 5 mg prednisone orally twice each day (BID) on each day of the treatment cycle
Drug: Lenalidomide (CC-5013) 10mg, 15mg, 20mg, 25mg and their respective matching placebo capsules for oral administration

DP treatment arm: Oral placebo once each day (QD) on Days 1-14 of the treatment cycle; 75 mg/m^2 docetaxel IV on Day 1; 5 mg prednisone orally twice each day (BID) on each day of the treatment cycle

DPL treatment arm: 25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel IV on Day 1; 5 mg prednisone orally twice each day (BID) on each day of the treatment cycle

Other Names:
  • Lenalidomide: Revlimid
  • Docetaxel: Taxotere
  • Prednisone: there are multiple brand names for prednisone

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00988208

  Show 198 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Debora Barton, MD Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00988208     History of Changes
Other Study ID Numbers: CC-5013-PC-002, EudraCT Number 2008-007969-23
Study First Received: October 1, 2009
Last Updated: May 14, 2012
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Denmark: Danish Medicines Agency
France: Afssaps - French Health Products Safety Agency
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Czech Republic: State Institute for Drug Control
Russia: Ministry of Health and Social Development of the Russian Federation
South Africa: Medicines Control Council
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Brazil: National Health Surveillance Agency
Mexico: Federal Commission for Sanitary Risks Protection
Greece: National Organization of Medicines
Sweden: Medical Products Agency

Keywords provided by Celgene Corporation:
Castrate-Resistant Prostate Cancer
Revlimid
Lenalidomide

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Prednisone
Docetaxel
Lenalidomide
Thalidomide
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on May 23, 2012