Study of Everolimus (RAD001) in Patients With Recurrent Glioblastoma Multiforme (GBM)

This study has been terminated.
(Early termination due to slow enrollment and protocol-defined stopping rule.)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00515086
First received: August 10, 2007
Last updated: September 20, 2011
Last verified: September 2011
Results First Received: December 15, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Glioblastoma Multiforme
Interventions: Drug: Everolimus
Procedure: Surgery

  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
Eligible participants were separated into 2 Groups: Group 1 (Surgery Group) patients were scheduled for salvage surgery and randomly assigned to one of 3 pre-surgery treatment groups: 0, 5 or 10 mg/day Everolimus for 7 days. Group 2 (No Surgery Group) patients were not scheduled for salvage surgery and received 10 mg/day Everolimus.

Reporting Groups
  Description
No Surgery (Everolimus 10 mg) Participants with recurrent Glioblastoma Multiforme (GBM) not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity.
Everolimus 10 mg + Surgery Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
Everolimus 5 mg + Surgery Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
Everolimus 0 mg + Surgery Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.

Participant Flow:   Overall Study
    No Surgery (Everolimus 10 mg)     Everolimus 10 mg + Surgery     Everolimus 5 mg + Surgery     Everolimus 0 mg + Surgery  
STARTED     24     6     5     6  
COMPLETED     0     0     0     0  
NOT COMPLETED     24     6     5     6  
Adverse Event                 1                 1                 2                 3  
Administrative                 1                 1                 0                 0  
Withdrawal by Subject                 1                 0                 0                 1  
Unsatisfactory therapeutic effect                 18                 3                 3                 2  
Lost to Follow-up                 1                 0                 0                 0  
Study drug no longer required                 0                 1                 0                 0  
Death                 2                 0                 0                 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
No Surgery (Everolimus 10 mg) Participants with recurrent Glioblastoma Multiforme (GBM) not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity.
Everolimus 10 mg + Surgery Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
Everolimus 5 mg + Surgery Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
Everolimus 0 mg + Surgery Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
Total Total of all reporting groups

Baseline Measures
    No Surgery (Everolimus 10 mg)     Everolimus 10 mg + Surgery     Everolimus 5 mg + Surgery     Everolimus 0 mg + Surgery     Total  
Number of Participants  
[units: participants]
  24     6     5     6     41  
Age  
[units: Participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     14     5     5     5     29  
>=65 years     10     1     0     1     12  
Gender  
[units: participants]
         
Female     5     4     0     4     13  
Male     19     2     5     2     28  



  Outcome Measures
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1.  Primary:   Surgery Group: Percentage Change From the Baseline in S6 Kinase Levels   [ Time Frame: Baseline and Day 7-9 (during salvage surgery) ]

2.  Primary:   No Surgery Group: Best Overall Tumor Response   [ Time Frame: First day of treatment to study discontinuation (up to 60 weeks) ]

3.  Secondary:   Surgery Group: Blood and Brain Tissue Levels of Everolimus (RAD001)   [ Time Frame: Baseline and Day 7-9 (Blood samples were collected one day prior to surgery and tissue samples were collected during surgery.) ]

4.  Secondary:   Surgery Group: Progression-free Survival   [ Time Frame: After surgery (within 96 hours), Weeks 4 and 8 and then every 8 weeks after restarting treatment until study discontinuation (Up to 28 weeks) ]

5.  Secondary:   Surgery Group: Biomarkers Phosphatase and Tensin Homolog (PTEN) and Epidermal Growth Factor Receptor (EGFR)   [ Time Frame: After surgery, week 4, week 8 and every 8 weeks thereafter ]

6.  Secondary:   No Surgery Group: Progression Free Survival   [ Time Frame: First day of treatment to study discontinuation (up to 60 weeks) ]

7.  Secondary:   Surgery Group: Number of Participants With Adverse Events   [ Time Frame: First day of treatment to study discontinuation (Up to 28 weeks) ]


  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
Due to the early termination of this study, the analysis of some of the planned objectives is not included in this clinical study report.


  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: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00515086     History of Changes
Other Study ID Numbers: CRAD001C2410
Study First Received: August 10, 2007
Results First Received: December 15, 2010
Last Updated: September 20, 2011
Health Authority: United States: Food and Drug Administration