RAD001 and Bicalutamide for Androgen Independent Prostate Cancer

This study has been terminated.
(Low overall response rate)
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00630344
First received: February 28, 2008
Last updated: January 20, 2014
Last verified: January 2014
Results First Received: January 20, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: RAD001
Drug: Bicalutamide

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
RAD-001 in Combination With Bicalutamide

RAD001 will be administered orally as once daily dose of 10 mg (5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Bicalutamide will be administered orally as once daily dose of 50 mg (50 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.

RAD001: Taken orally once daily

Bicalutamide: Taken orally once daily


Participant Flow:   Overall Study
    RAD-001 in Combination With Bicalutamide  
STARTED     36  
COMPLETED     36  
NOT COMPLETED     0  



  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.
No text entered.

Reporting Groups
  Description
RAD-001 in Combination With Bicalutamide

RAD001 will be administered orally as once daily dose of 10 mg (5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Bicalutamide will be administered orally as once daily dose of 50 mg (50 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.

RAD001: Taken orally once daily

Bicalutamide: Taken orally once daily


Baseline Measures
    RAD-001 in Combination With Bicalutamide  
Number of Participants  
[units: participants]
  36  
Age  
[units: years]
Median ( Inter-Quartile Range )
  68  
  ( 60 to 72 )  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     13  
>=65 years     23  
Gender  
[units: participants]
 
Female     0  
Male     36  
Region of Enrollment  
[units: participants]
 
United States     36  



  Outcome Measures

1.  Primary:   To Determine the Best Overall Response and Duration of Response, Taking Into Consideration Measurable Disease, Bone Metastases and PSA.   [ Time Frame: 3 years ]

2.  Secondary:   To Characterize the Toxicity Profile of RAD001 in Combination With Standard Dose Bicalutamide in Patients With Androgen Independent Prostate Cancer.   [ Time Frame: 3 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  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 NOT 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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Mary-Ellen Taplin, MD
Organization: Dana-Farber Cancer Institute
phone: 617-582-8313
e-mail: mary_taplin@dfci.harvard.edu


No publications provided


Responsible Party: Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00630344     History of Changes
Other Study ID Numbers: 07-316
Study First Received: February 28, 2008
Results First Received: January 20, 2014
Last Updated: January 20, 2014
Health Authority: United States: Food and Drug Administration