Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Treatment of Refractory Metastatic Renal Cell Carcinoma With Bevacizumab and RAD001 (Everolimus)

This study has been terminated.
(slow accrual)
Sponsor:
Collaborators:
Genentech, Inc.
Novartis
Information provided by (Responsible Party):
Sandy Srinivas, Stanford University
ClinicalTrials.gov Identifier:
NCT00651482
First received: March 28, 2008
Last updated: June 30, 2014
Last verified: June 2014
Results First Received: June 30, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Kidney Neoplasms
Kidney (Renal Cell) Cancer
Interventions: Drug: Everolimus
Drug: Bevacizumab

  Participant Flow
  Hide 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
Bevacizumab + RAD001 (Everolimus)

Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles

Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)

Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)

Everolimus

Bevacizumab


Participant Flow:   Overall Study
    Bevacizumab + RAD001 (Everolimus)  
STARTED     10  
COMPLETED     10  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide 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
Bevacizumab + RAD001 (Everolimus)

Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles

Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)

Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)

Everolimus

Bevacizumab


Baseline Measures
    Bevacizumab + RAD001 (Everolimus)  
Number of Participants  
[units: participants]
  10  
Age  
[units: years]
Median ( Full Range )
  55  
  ( 41 to 77 )  
Gender  
[units: participants]
 
Female     1  
Male     9  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     1  
White     6  
More than one race     0  
Unknown or Not Reported     2  
Region of Enrollment  
[units: participants]
 
United States     10  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: 24 months ]

2.  Secondary:   Objective Response (OR)   [ Time Frame: 24 months ]

3.  Secondary:   Objective Response (OR) Duration   [ Time Frame: 24 months ]

4.  Secondary:   Time-to-Treatment Failure (TTF)   [ Time Frame: 24 months ]

5.  Secondary:   Overall Survival (OS)   [ Time Frame: 44 months ]

6.  Secondary:   Number of Subjects With Drug-related SAEs   [ Time Frame: 24 months ]

7.  Secondary:   Total Number of Drug-related SAEs   [ Time Frame: 24 months ]

8.  Secondary:   Treatment Discontinuation Due to Toxicity   [ Time Frame: 24 months ]

9.  Secondary:   Treatment Discontinuation Due to Disease Progression   [ Time Frame: 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide 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: Associate Professor of Medicine (Oncology)
Organization: Stanford University Medical Center
phone: 650-725-2078
e-mail: sandysri@stanford.edu


Publications:

Responsible Party: Sandy Srinivas, Stanford University
ClinicalTrials.gov Identifier: NCT00651482     History of Changes
Other Study ID Numbers: IRB-11789, RENAL0016, 98593, AVF4304s, 41839
Study First Received: March 28, 2008
Results First Received: June 30, 2014
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board