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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene
ClinicalTrials.gov Identifier:
NCT00988208
First received: October 1, 2009
Last updated: April 4, 2017
Last verified: April 2017
Results First Received: June 27, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: Lenalidomide
Drug: Docetaxel
Drug: Prednisone
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Following a safety and efficacy data review by the Data Monitoring Committee( DMC), the trial was stopped for futility. At that time, 1059 participants had been randomized and 1046 treated with either lenalidomide plus docetaxel and prednisone or placebo plus docetaxel and prednisone. A data cutoff date of 13 January 2012 was established.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who had started a treatment cycle at the time of termination request were allowed to complete the cycle and have their discontinuation visit at the next cycle (21 days later). The safety follow-up of 28 days was also added to ensure all adverse events were followed.

Reporting Groups
  Description
Docetaxel/Prednisone/Placebo (DP) The 21-day treatment regimen consisted of: identical matching oral placebo once each day (QD) on Days 1-14; 75 mg/m^2 Docetaxel Intravenous (IV) on Day 1 and 5 mg Prednisone orally twice each day (BID) of the treatment cycle, Days 1-21 (21 days).
Docetaxel/Prednisone/Lenalidomide (DPL) The 21-day treatment regimen consisted of: 25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel (IV) on Day 1 and 5 mg prednisone orally twice each day (BID) each day of the treatment cycle, Days 1-21 (21 days).

Participant Flow:   Overall Study
    Docetaxel/Prednisone/Placebo (DP)   Docetaxel/Prednisone/Lenalidomide (DPL)
STARTED   526   533 
Treated   521   525 
COMPLETED   95 [1]   95 [2] 
NOT COMPLETED   431   438 
Adverse Event                71                122 
Disease Progression                103                89 
Withdrawal by Subject                50                57 
Death                9                15 
Lost to Follow-up                2                3 
Protocol Violation                9                2 
Sponsor Decision                102                78 
Clinical Progression                17                16 
Biochemical Progression                21                7 
Clinical Deterioration                7                14 
Subject decision/investigator discretion                32                32 
Unspecified                8                3 
[1] DP Completed = kept on treatment with docetaxel/prednisone; Placebo was discontinued in DP arm
[2] DPL Completed = kept on treatment with docetaxel/prednisone; Lenalidomide discontinued in DPL arm



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Includes those from the Intent to Treat population (ITT). The ITT Population is defined as all subjects who are randomized, independent of whether they received study treatment or not.

Reporting Groups
  Description
Oral Placebo + Docetaxel IV Day 1 + Prednisone (DP) The 21-day treatment regimen consisted of: identical matching oral placebo once each day (QD) on Days 1-14; 75 mg/m^2 Docetaxel Intravenous (IV) on Day 1 and 5 mg Prednisone orally twice each day (BID) of the treatment cycle, Days 1-21 (21 days).
Docetaxel + Prednisone + Lenalidomide (DPL) The 21-day treatment regimen consisted of: 25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel (IV) on Day 1 and 5 mg prednisone orally twice each day (BID) each day of the treatment cycle, Days 1-21 (21 days).
Total Total of all reporting groups

Baseline Measures
   Oral Placebo + Docetaxel IV Day 1 + Prednisone (DP)   Docetaxel + Prednisone + Lenalidomide (DPL)   Total 
Overall Participants Analyzed 
[Units: Participants]
 526   533   1059 
Age 
[Units: Years]
Mean (Standard Deviation)
 68.4  (7.79)   68.9  (7.98)   68.7  (7.89) 
Age, Customized 
[Units: Participants]
     
<65   171   163   334 
> = to 65 years and < = 75years   246   244   490 
>75   109   126   235 
Sex/Gender, Customized 
[Units: Male participants]
 526   533   1059 
Region of Enrollment [1] 
[Units: Participants]
     
US or Canada   136   140   276 
EU or Australia   329   330   659 
Rest of World (Includes 4 additional countries)   61   63   124 
[1] Rest of World includes Israel, Russia, Mexico and South Africa
Race, Customized 
[Units: Participants]
     
White   433   436   869 
Other or no answer   55   67   122 
Black or African American   25   21   46 
Asian   8   6   14 
American Indian or Alaska Native   5   3   8 
Weight 
[Units: Kilograms]
Mean (Standard Deviation)
 86.4  (16.18)   86  (15.70)   86.2  (15.93) 
Height 
[Units: Centimeters]
Mean (Standard Deviation)
 174.0  (7.81)   174.4  (7.38)   174.2  (7.60) 
Body Mass Index [1] 
[Units: (kg/m^2)]
Mean (Standard Deviation)
 28.6  (5.02)   28.3  (4.60)   28.4  (4.81) 
[1] BMI or body mass index is a statistical benchmark that compares an individual’s height and weight.
Body Mass Index, Categorical 
[Units: (kg/m^2)]
     
<25   134   138   272 
25-30   221   243   464 
>30   171   152   323 
ECOG Performance Status [1] 
[Units: Participants]
     
0 (Fully Active)   257   252   509 
1 (Restrictive but ambulatory)   247   256   503 
2 (Ambulatory but unable to work)   21   24   45 
3 (Limited self-care)   1   0   1 
Not specified   0   1   1 
[1] Eastern Cooperative Oncology Group (ECOG) Performance Status is used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living activities of the patient and determine appropriate treatment and prognosis.
Type of disease progression [1] 
[Units: Participants]
     
Rising PSA only   146   159   305 
Radiographic progression   380   374   754 
[1] Categories of specific indicators of disease progression type
Prior radiotherapy [1] 
[Units: Participants]
     
Yes   308   312   620 
No   218   221   439 
[1] Participants who had been treated with prior radiation therapy
Prior cancer surgery [1] 
[Units: Participants]
     
Yes   335   358   693 
No   191   175   366 
[1] Participants who had undergone a surgical procedure associated with their prostate cancer diagnosis prior to study participation
Other prior anti-cancer therapy [1] 
[Units: Participants]
     
Yes   79   71   150 
No   447   462   909 
[1] Participants who were treated with other types of anti-cancer therapies prior to participation in study
Baseline PSA (Prostate Specific Antigen) levels [1] 
[Units: (ng/ml)]
Mean (Standard Deviation)
 290.359  (659.1583)   316.501  (776.1133)   303.542  (720.2895) 
[1] Prostate-specific antigen (PSA) is a substance produced by the prostate gland. Elevated PSA levels may indicate prostate cancer or a noncancerous condition such as prostatitis or an enlarged prostate.
Metastatic sites of disease outside of prostate [1] 
[Units: Participants]
     
Bone only   157   169   326 
Soft tissues only   94   104   198 
Both bone and Soft tissues   273   259   532 
None   2   1   3 
[1] Specific sites of the body that have advanced spread of the prostate cancer.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival (OS)   [ Time Frame: Randomization until death from any cause up to the cut-off date of 13 January 2012 ]

2.  Secondary:   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 ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The independent DMC concluded that it was unlikely the trial would achieve its primary endpoint of improved overall survival. The sponsor agreed and the experimental lenalidomide/placebo treatment arm of the study was discontinued.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Manager , Clinical Trials Disclosure
Organization: Celgene Corporation
phone: 1-888-260-1599
e-mail: clinicaltrialdisclosure@celgene.com


Publications of Results:

Responsible Party: Celgene
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
Results First Received: June 27, 2013
Last Updated: April 4, 2017