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A Study of Avastin (Bevacizumab) And Fotemustine in Patients With Recurrent Glioblastoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01474239
First received: November 8, 2011
Last updated: February 16, 2016
Last verified: September 2015
Results First Received: July 9, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Glioblastoma Multiforme
Interventions: Drug: bevacizumab [Avastin]
Drug: fotemustine

  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
Study included 28-day screening period. Participants were randomized according to a 2:1 ratio to one of the 2 treatment groups. A total of 99 participants were screened, of which 91 were randomized.

Reporting Groups
  Description
Bevacizumab Participants received bevacizumab 10 milligrams per kilogram (mg/kg) via intravenous (IV) infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
Fotemustine Participants received fotemustine 75 milligrams per square meter (mg/m^2) via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.

Participant Flow:   Overall Study
    Bevacizumab     Fotemustine  
STARTED     59     32  
COMPLETED     0     0  
NOT COMPLETED     59     32  
Disease Progression                 37                 25  
Adverse Event                 12                 3  
Withdrawal by Subject                 1                 2  
Death                 1                 1  
Clinical Disease Progression                 7                 1  
Withdrawal for Economic Reason                 1                 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.
Safety population included all randomized participants with at least one administration of the study drug and at least one safety assessment.

Reporting Groups
  Description
Bevacizumab Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
Fotemustine Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
Total Total of all reporting groups

Baseline Measures
    Bevacizumab     Fotemustine     Total  
Number of Participants  
[units: participants]
  59     32     91  
Age  
[units: years]
Mean (Standard Deviation)
  56.86  (9.40)     55.63  (10.64)     56.43  (9.81)  
Gender  
[units: participants]
     
Female     20     9     29  
Male     39     23     62  



  Outcome Measures
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1.  Primary:   Percentage of Participants Alive 6 Months After Start of Treatment   [ Time Frame: 6 months ]

2.  Primary:   Overall Survival (OS)   [ Time Frame: Baseline until death (up to 691 days) ]

3.  Secondary:   Percentage of Participants Who Were Alive and Progression Free 6 Months After Start of Treatment   [ Time Frame: 6 months ]

4.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Baseline until disease progression or death (baseline, 46 days after first administration of study drug, and thereafter every 56 days up to 691 days) ]

5.  Secondary:   Percentage of Participants Alive 9 Months After Start of Treatment   [ Time Frame: 9 months ]

6.  Secondary:   Percentage of Participants Alive 12 Months After Start of Treatment   [ Time Frame: 12 months ]

7.  Secondary:   Percentage of Participants Alive 30 Days After Last Dose of Study Drug   [ Time Frame: 30 days after last dose of study drug (up to Day 600) ]

8.  Secondary:   Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR)   [ Time Frame: Baseline until disease progression or death (baseline, 46 days after first administration of study drug, and thereafter every 56 days up to 691 days) ]

9.  Secondary:   Change From Screening in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores at Weeks 8, 16, 24, 32, 40, 48, 56, 64, and 72   [ Time Frame: Screening, Weeks 8, 16, 24, 32, 40, 48, 56, 64, and 72 ]

10.  Secondary:   Percentage of Participants With Corticosteroid Initiation During the Study Period   [ Time Frame: Baseline until recurrence (up to 691 days) ]

11.  Secondary:   Time to Corticosteroid Initiation   [ Time Frame: Baseline until recurrence (up to 691 days) ]

12.  Secondary:   Percentage of Participants in Each Class of Corticosteroid Use   [ Time Frame: Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, post-treatment follow-up (up to Day 691) ]

13.  Secondary:   Percentage of Participants With Karnofsky Performance Status (KPS) Deterioration   [ Time Frame: Baseline until KPS deterioration (up to 691 days) ]

14.  Secondary:   Time to Karnofsky Performance Status (KPS) Deterioration   [ Time Frame: Baseline until KPS deterioration (up to 691 days) ]

15.  Secondary:   Percentage of Participants With World Health Organization (WHO) Performance Status (PS) Deterioration   [ Time Frame: Baseline until WHO PS deterioration (Up to 691 days) ]

16.  Secondary:   Time to WHO PS Deterioration   [ Time Frame: Baseline until WHO PS deterioration (Up to 691 days) ]


  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:  
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: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01474239     History of Changes
Other Study ID Numbers: ML25739
Study First Received: November 8, 2011
Results First Received: July 9, 2015
Last Updated: February 16, 2016
Health Authority: Italy: Ministry of Health