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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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 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

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) Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
Docetaxel/Prednisone/Lenalidomide (DPL) Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.

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 
Other                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

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 participants who were randomized, independent of whether they received study treatment or not.

Reporting Groups
  Description
Docetaxel/Prednisone/Placebo (DP) Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
Docetaxel/Prednisone/Lenalidomide (DPL) Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
Total Total of all reporting groups

Baseline Measures
   Docetaxel/Prednisone/Placebo (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]
Count of Participants
     
<65 years      171  32.5%      163  30.6%      334  31.5% 
> = to 65 years and < = 75years      246  46.8%      244  45.8%      490  46.3% 
>75 years      109  20.7%      126  23.6%      235  22.2% 
Sex/Gender, Customized 
[Units: Participants]
     
male   526   533   1059 
female   0   0   0 
Region of Enrollment [1] 
[Units: Participants]
Count of Participants
     
US or Canada      136  25.9%      140  26.3%      276  26.1% 
EU or Australia      329  62.5%      330  61.9%      659  62.2% 
Rest of World (Includes 4 additional countries)      61  11.6%      63  11.8%      124  11.7% 
[1] Rest of World includes Israel, Russia, Mexico and South Africa
Race, Customized 
[Units: Participants]
Count of Participants
     
White      433  82.3%      436  81.8%      869  82.1% 
Other or no answer      55  10.5%      67  12.6%      122  11.5% 
Black or African American      25   4.8%      21   3.9%      46   4.3% 
Asian      8   1.5%      6   1.1%      14   1.3% 
American Indian or Alaska Native      5   1.0%      3   0.6%      8   0.8% 
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: Participants]
Count of Participants
     
<25 kg/m^2      134  25.5%      138  25.9%      272  25.7% 
25-30 kg/m^2      221  42.0%      243  45.6%      464  43.8% 
>30 kg/m^2      171  32.5%      152  28.5%      323  30.5% 
ECOG Performance Status [1] 
[Units: Participants]
Count of Participants
     
0 (Fully Active)      257  48.9%      252  47.3%      509  48.1% 
1 (Restrictive but ambulatory)      247  47.0%      256  48.0%      503  47.5% 
2 (Ambulatory but unable to work)      21   4.0%      24   4.5%      45   4.2% 
3 (Limited self-care)      1   0.2%      0   0.0%      1   0.1% 
Not specified      0   0.0%      1   0.2%      1   0.1% 
[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]
Count of Participants
     
Rising PSA only      146  27.8%      159  29.8%      305  28.8% 
Radiographic progression      380  72.2%      374  70.2%      754  71.2% 
[1] Categories of specific indicators of disease progression type
Prior Radiotherapy [1] 
[Units: Participants]
Count of Participants
     
Yes      308  58.6%      312  58.5%      620  58.5% 
No      218  41.4%      221  41.5%      439  41.5% 
[1] Participants who had been treated with prior radiation therapy
Prior Cancer Surgery [1] 
[Units: Participants]
Count of Participants
     
Yes      335  63.7%      358  67.2%      693  65.4% 
No      191  36.3%      175  32.8%      366  34.6% 
[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]
Count of Participants
     
Yes      79  15.0%      71  13.3%      150  14.2% 
No      447  85.0%      462  86.7%      909  85.8% 
[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]
Count of Participants
     
Bone only      157  29.8%      169  31.7%      326  30.8% 
Soft tissues only      94  17.9%      104  19.5%      198  18.7% 
Both bone and Soft tissues      273  51.9%      259  48.6%      532  50.2% 
None      2   0.4%      1   0.2%      3   0.3% 
[1] Specific sites of the body that have advanced spread of the prostate cancer.


  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   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 ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]

5.  Secondary:   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 ]

6.  Secondary:   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 ]

7.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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:
Other Publications:

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT00988208     History of Changes
Other Study ID Numbers: CC-5013-PC-002
EudraCT Number 2008-007969-23
First Submitted: October 1, 2009
First Posted: October 2, 2009
Results First Submitted: June 27, 2013
Results First Posted: September 5, 2013
Last Update Posted: April 4, 2018