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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)

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ClinicalTrials.gov Identifier: NCT00988208
Recruitment Status : Completed
First Posted : October 2, 2009
Results First Posted : September 5, 2013
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Prostate Cancer Drug: Lenalidomide Drug: Docetaxel Drug: Prednisone Drug: Placebo Phase 3

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1059 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 (CRPC)
Actual Study Start Date : November 11, 2009
Actual Primary Completion Date : January 13, 2012
Actual Study Completion Date : November 28, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Docetaxel, Prednisone, Lenalidomide (DPL)
25 mg lenalidomide orally once each day on Days 1-14; 75 mg/m2 docetaxel intravenously on Day 1; 5 mg prednisone orally twice daily on each day of the treatment cycle
 Drug: Lenalidomide
25 mg lenalidomide orally once each day on Days 1-14
Other Names:
  • CC-5013
  • Revlimid

Drug: Docetaxel
75 mg/m2 intravenous docetaxel on Day 1
Other Name: Taxotere

Drug: Prednisone
5 mg prednisone orally twice daily on each day of the treatment cycle
Other Name: There are multiple brand names for prednisone.
Experimental: Docetaxel and Prednisone (DP)
Oral placebo once each day on Days 1-14 of the treatment cycle; 75 mg/m2 docetaxel intravenously on Day 1; 5 mg prednisone orally twice each day on each day of the treatment cycle
 Drug: Docetaxel
75 mg/m2 intravenous docetaxel on Day 1
Other Name: Taxotere

Drug: Prednisone
5 mg prednisone orally twice daily on each day of the treatment cycle
Other Name: There are multiple brand names for prednisone.

Drug: Placebo
Oral placebo once each day on Days 1-14 of the treatment cycle


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: From randomization until death from any cause up to the cut-off date of 13 January 2012; up to approximately 26 months ]
    Overall survival (OS) was the time from the date of randomization to the date of death from any cause. If no death was reported for a participant before the cut-off date for OS analysis, OS was censored at the last date at which the participant was alive. The median OS was calculated based on Kaplan-Meier estimates and corresponding 95% confidence interval (CI) was calculated using the method provided by Brookmeyer and Crowley.


Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: From randomization until disease progression or death from any cause; up to the cut-off date of 13 Jan 2012; maximum time on study was approximately 26 months ]
    PFS was the time from randomization to disease progression, or death, whatever occurred first. Progression criteria was met by analysis of target and non-target lesions as defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters while on study or the appearance of one or more new lesions; an increase of at least 5mm as a total sum. Lymph nodes identified as target lesions (≥ 15 mm diameter in short axis) will be followed and reported by changes in diameter of short axis; or the unequivocal progression of a non-target lesion defined as an increase in the overall disease burden based on the change in non-measurable disease that is comparable in scope to the increase required to declare PD for measurable disease; Two or more new bone lesions as detected by bone scan

  2. Percentage of Participants With an Objective Response According to Response Evaluation Criteria in Solid Tumors - RECIST Version 1.1 Criteria [ Time Frame: From day 1 to data cut-off 13 January 2012; maximum time on study was approximately 26 months ]
    Objective response (OR) is defined as having complete response (CR) or partial response (PR) as best overall response based on RECIST Criteria 1.1 and defines a CR = Disappearance of all target lesions except lymph nodes (LN); LN must have a decrease in the short axis to <10mm; PR = 30% decrease in sum of diameters of target lesions taking as reference the baseline sum diameters; Progressed Disease (PD) = 20% increase in sum of diameters of target lesions taking as a reference the smallest sum of diameters and an absolute increase of ≥5 mm; the appearance of ≥1 new lesions; Stable Disease (SD)= Neither shrinkage to qualify for PR nor increase to qualify for PD taking the smallest sum diameters on study as reference. For non-target lesions a CR = Disappearance of all non-target lesions and all LN must be non-pathological in size <10 mm; Non-CR/Non PD: persistence of one or more non-target lesions; PD = unequivocal progression of existing non-target lesions or appearance of new ones

  3. Number of Participants With Treatment Emergent Adverse Events (AEs) [ Time Frame: From the time from of first dose of study drug administration to 28 days after the last dose of study drug and up to the data cut off date of 13 January 2012; the maximum duration of study drug was 93 weeks for DP and 90.6 weeks for DPL ]
    A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. A TESAE is defined as any serious adverse event (SAE) occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;

  4. Percentage of Participants Who Received Post-Study Therapies [ Time Frame: The date when the first consent form was signed to the last date of AE data collection;up to 5 years; up to the date of the final data analysis date of 20 April 2017 ]
    Percentage of Participants Who Received Post-Study Therapies for advanced Prostate Cancer.

  5. Percentage of Participants With Secondary Primary Malignancies During the Course of the Trial [ Time Frame: The date when the first consent form was signed to the last date of AE data collection; up to the date of the final data analysis date of 30 November 2016; 7 years and 19 days ]
    Second primary malignancies were monitored as events of interest and reported as serious adverse events throughout the course of the trial.

  6. Time to Onset of Secondary Primary Malignancies [ Time Frame: The date when the first consent form was signed to the last date of AE data collection; up to the date of the final data analysis date of 30 November 2016; 7 years and 19 days ]
    Time of Onset of Secondary Primary Malignancies was considered an event of interest


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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. 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 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00988208


Locations
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Sponsors and Collaborators
Celgene
Investigators
Layout table for investigator information
Study Director: Debora Barton, MD Celgene Corporation
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT00988208    
Other Study ID Numbers: CC-5013-PC-002
EudraCT Number 2008-007969-23
First Posted: October 2, 2009    Key Record Dates
Results First Posted: September 5, 2013
Last Update Posted: April 4, 2018
Last Verified: March 2018
Keywords provided by Celgene:
Castrate-Resistant Prostate Cancer
Revlimid
Lenalidomide
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Prednisone
Docetaxel
Lenalidomide
Antineoplastic Agents
Tubulin Modulators
 Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Immunologic Factors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors