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Bicalutamide With or Without Everolimus in Treating Patients With Recurrent or Metastatic Prostate Cancer (UCDCC#215)

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00814788
First received: December 24, 2008
Last updated: May 1, 2017
Last verified: May 2017
Results First Received: March 6, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: Bicalutamide
Drug: Everolimus

  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
Bicalutamide + Everolimus

Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Bicalutamide 50 mg oral daily

Everolimus: RAD001 10 mg oral capsule daily - continuously.


Participant Flow:   Overall Study
    Bicalutamide + Everolimus
STARTED   24 
COMPLETED   24 
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
Bicalutamide + Everolimus

Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

bicalutamide: Bicalutamide 50 mg oral daily

Everolimus: RAD001 10 mg oral capsule daily - continuously.


Baseline Measures
   Bicalutamide + Everolimus 
Overall Participants Analyzed 
[Units: Participants]
 24 
Age 
[Units: Years]
Mean (Full Range)
 71.1 
 (53 to 87) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      24 100.0% 
Region of Enrollment 
[Units: Participants]
 
United States   24 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   PSA Response Rate   [ Time Frame: Up to 2 years ]

2.  Secondary:   Progression-free Survival   [ Time Frame: Up to 2 years ]

3.  Secondary:   Overall Survival   [ Time Frame: Up to 3 years ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Analyst
Organization: University of California Davis
phone: 916 734 0294
e-mail: pkaujla@ucdavis.edu


Publications:

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00814788     History of Changes
Other Study ID Numbers: UCDCC#215
Novartis ( Other Grant/Funding Number: CRAD001CUS53T )
Study First Received: December 24, 2008
Results First Received: March 6, 2017
Last Updated: May 1, 2017