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.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00988208
First received: October 1, 2009
Last updated: July 8, 2014
Last verified: July 2014

October 1, 2009
July 8, 2014
November 2009
January 2012   (final data collection date for primary outcome measure)
Overall Survival (OS) [ Time Frame: Randomization until death from any cause up to the cut-off date of 13 January 2012 ] [ Designated as safety issue: No ]
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.
Overall Survival [ Time Frame: Cycle 1 Day 1 until subject death ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00988208 on ClinicalTrials.gov Archive Site
  • Progression-free Survival (PFS) [ Time Frame: Randomization until disease progression or death from any cause up to cut-off date of 13 Jan 2012; maximum time on study approximately 26 months ] [ Designated as safety issue: No ]
    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 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
  • Objective Response Rate (ORR) of Measurable and/or Non-measurable Disease as Determined by Investigators According to RECIST Version 1.1 Criteria [ Time Frame: Day 1 to data cut-off 13 January 2012; maximum time on study approximately 26 months ] [ Designated as safety issue: No ]
    Objective response (OR) is defined as having complete response (CR) or partial response (PR) as best overall response. RECIST Criteria 1.1 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
  • Number of Participants With Treatment Emergent Adverse Events (AEs) [ Time Frame: The maximum duration on study drug was 93 weeks, which includes the time from the 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 ] [ Designated as safety issue: Yes ]
    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;
  • 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 ]
Not Provided
Not Provided
 
Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer
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)

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Prostate Cancer
  • 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.
  • Drug: Placebo
    Oral placebo once each day on Days 1-14 of the treatment cycle
  • 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
    Interventions:
    • Drug: Lenalidomide
    • Drug: Docetaxel
    • Drug: 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
    Interventions:
    • Drug: Docetaxel
    • Drug: Prednisone
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1059
November 2016
January 2012   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Mexico,   Netherlands,   Poland,   Russian Federation,   South Africa,   Spain,   Sweden,   United Kingdom
 
NCT00988208
CC-5013-PC-002, EudraCT Number 2008-007969-23
Yes
Celgene Corporation
Celgene Corporation
Not Provided
Study Director: Debora Barton, MD Celgene Corporation
Celgene Corporation
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP