Trial of the Combination of Bevacizumab and Everolimus in Patients With Refractory, Progressive Intracranial Meningioma

This study has been terminated.
(Study terminated early due to slow accrual)
Sponsor:
Collaborators:
Genentech, Inc.
Novartis
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00972335
First received: September 2, 2009
Last updated: May 18, 2015
Last verified: May 2015
Results First Received: January 5, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Intracranial Meningioma
Interventions: Drug: Everolimus
Drug: Bevacizumab

  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
Combination Therapy

Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.

Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study


Participant Flow:   Overall Study
    Combination Therapy  
STARTED     17 [1]
COMPLETED     0 [2]
NOT COMPLETED     17  
[1] One patient was enrolled but showed no evidence of disease at study entry and was not treated
[2] Patients were on study until an event or condition occured which required them to come off study



  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.
All treated patients (one enrolled patient was not treated)

Reporting Groups
  Description
Combination Therapy

Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.

Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study


Baseline Measures
    Combination Therapy  
Number of Participants  
[units: participants]
  17  
Age  
[units: years]
Median (Full Range)
  59   (29 to 84)  
Gender  
[units: participants]
 
Female     9  
Male     8  
Region of Enrollment  
[units: participants]
 
United States     17  



  Outcome Measures
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1.  Primary:   Progression-free Survival (PFS), in the Treatment of Patients With Refractory Meningioma.   [ Time Frame: 18 months ]

2.  Secondary:   To Evaluate the Toxicity of Bevacizumab/Everolimus in Patients With Recurrent Meningioma.   [ Time Frame: 18 months ]

3.  Secondary:   To Correlate the Activity of This Treatment Regimen With Expression of Selected Intra-tumoral Biomarkers.   [ Time Frame: 18 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
Enrollment closed early due to slow accrual, leading to small number of subjects analyzed - biomarker analysis outcome measure not analyzed or reported


  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.


Results Point of Contact:  
Name/Title: John D Hainsworth, MD
Organization: Sarah Cannon Research Institute
phone: 1-877-691-7274
e-mail: asksarah@scresearch.net


No publications provided


Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00972335     History of Changes
Other Study ID Numbers: SCRI CNS 12
Study First Received: September 2, 2009
Results First Received: January 5, 2015
Last Updated: May 18, 2015
Health Authority: United States: Food and Drug Administration