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: March 17, 2014
Last verified: March 2014
Results First Received: June 27, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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  
Number of Participants  
[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  
Gender, Customized  
[units: male┬áparticipants]
  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  
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 [2]
[units: (kg/m^2)]
Mean ± Standard Deviation
  28.6  ± 5.02     28.3  ± 4.60     28.4  ± 4.81  
Body Mass Index, Categorical  
[units: (kg/m^2)]
     
<25     134     138     272  
25-30     221     243     464  
>30     171     152     323  
ECOG Performance Status [3]
[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  
Type of disease progression [4]
[units: participants]
     
Rising PSA only     146     159     305  
Radiographic progression     380     374     754  
Prior radiotherapy [5]
[units: participants]
     
Yes     308     312     620  
No     218     221     439  
Prior cancer surgery [6]
[units: participants]
     
Yes     335     358     693  
No     191     175     366  
Other prior anti-cancer therapy [7]
[units: participants]
     
Yes     79     71     150  
No     447     462     909  
Baseline PSA (Prostate Specific Antigen) levels [8]
[units: (ng/ml)]
Mean ± Standard Deviation
  290.359  ± 659.1583     316.501  ± 776.1133     303.542  ± 720.2895  
Metastatic sites of disease outside of prostate [9]
[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] Rest of World includes Israel, Russia, Mexico and South Africa
[2] BMI or body mass index is a statistical benchmark that compares an individual’s height and weight.
[3] 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.
[4] Categories of specific indicators of disease progression type
[5] Participants who had been treated with prior radiation therapy
[6] Participants who had undergone a surgical procedure associated with their prostate cancer diagnosis prior to study participation
[7] Participants who were treated with other types of anti-cancer therapies prior to participation in study
[8] 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.
[9] 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


  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.


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.  


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


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
Results First Received: June 27, 2013
Last Updated: March 17, 2014
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: Agence Nationale de Sécurité du Médicament et des produits de santé
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 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