We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

RAD001 and Bicalutamide for Androgen Independent Prostate Cancer

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: NCT00630344
Recruitment Status : Completed
First Posted : March 7, 2008
Results First Posted : March 3, 2014
Last Update Posted : December 8, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: RAD001
Drug: Bicalutamide

  Participant Flow

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
RAD001 + Bicalutamide

RAD001: once daily dose of 10 mg (5 mg tablets)

Bicalutamide: once daily dose of 50 mg (50 mg tablets)

1 cycle=28 days

Both agents are administered continuously until progression of disease or unacceptable toxicity.


Participant Flow:   Overall Study
    RAD001 + Bicalutamide
STARTED   36 
COMPLETED   0 
NOT COMPLETED   36 
Adverse Event                5 
Progressive Disease                19 
Physician Decision                9 
Withdrawal by Subject                1 
Intercurrent Illness                1 
Other                1 



  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.
No text entered.

Reporting Groups
  Description
RAD-001 in Combination With Bicalutamide

RAD001: once daily dose of 10 mg (5 mg tablets)

Bicalutamide: once daily dose of 50 mg (50 mg tablets)

1 cycle=28 days

Both agents are administered continuously until progression of disease or unacceptable toxicity.


Baseline Measures
   RAD-001 in Combination With Bicalutamide 
Overall Participants Analyzed 
[Units: Participants]
 36 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      13  36.1% 
>=65 years      23  63.9% 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 68 
 (60 to 72) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      36 100.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   36 


  Outcome Measures

1.  Primary:   Overall Response Rate   [ Time Frame: PSA was measured monthly and measurable disease on imaging assessed every 2 cycles in first 8 weeks and every 3 cycles thereafter. In this study cohort, patients were followed on treatment up to approximately 1 year. ]

2.  Secondary:   Incidence of Grade 4 Treatment-Related Toxicity   [ Time Frame: Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort. ]

3.  Secondary:   Incidence of Grade 1-3 Treatment-Related Mucositis Toxicity   [ Time Frame: Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort. ]

4.  Secondary:   Incidence of Grade 1-3 Treatment-Related Rash Toxicity   [ Time Frame: Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort. ]

5.  Secondary:   Incidence of Grade 1-3 Treatment-Related Fatigue Toxicity   [ Time Frame: Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort. ]

6.  Secondary:   Time to Progression (TTP)   [ Time Frame: PSA was measured monthly and measurable disease on imaging assessed every 2 cycles in first 8 weeks and every 3 cycles thereafter. In this study cohort, patients were followed on treatment up to approximately 1 year. ]


  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
No text entered.


  More Information

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.


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


Publications of Results:

Responsible Party: Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00630344     History of Changes
Other Study ID Numbers: 07-316
First Submitted: February 28, 2008
First Posted: March 7, 2008
Results First Submitted: January 20, 2014
Results First Posted: March 3, 2014
Last Update Posted: December 8, 2017