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BIBF 1120 for Recurrent High-Grade Gliomas

This study has been completed.
Sponsor:
Collaborators:
Boehringer Ingelheim
Wake Forest Baptist Health
University of Virginia
Massachusetts General Hospital
The Cleveland Clinic
Information provided by (Responsible Party):
Patrick Y. Wen, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01380782
First received: June 21, 2011
Last updated: August 15, 2014
Last verified: August 2014
Results First Received: July 14, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Glioblastoma
Gliosarcoma
Anaplastic Astrocytoma
Anaplastic Oligodendroglioma
Anaplastic Oligoastrocytoma
Intervention: Drug: BIBF 1120

  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
Study activated at Dana-Farber Cancer Institute in May 2012 and was eventually activated at Massachusetts General Hospital, Cleveland Clinic, and University of Virginia. The bevacizumab-treated arm closed to accrual in December 2012 and the bevacizumab-naive arm closed in March 2013, both due to futility.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
N/A

Reporting Groups
  Description
Arm A (Bevacizumab-naive) - GBM Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was glioblastoma (GBM).
Arm A (Bevacizumab-naive) - AG Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was anaplastic glioma (AG).
Arm B (Bevacizumab Treated) - GBM Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was glioblastoma (GBM).
Arm B (Bevacizumab Treated) - AG Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was anaplastic glioma (AG).

Participant Flow:   Overall Study
    Arm A (Bevacizumab-naive) - GBM     Arm A (Bevacizumab-naive) - AG     Arm B (Bevacizumab Treated) - GBM     Arm B (Bevacizumab Treated) - AG  
STARTED     12     10     11     4  
COMPLETED     0     0     0     0  
NOT COMPLETED     12     10     11     4  
Adverse Event                 0                 1                 0                 0  
Death                 1                 0                 0                 0  
Lack of Efficacy                 10                 9                 10                 3  
Physician Decision                 1                 0                 0                 0  
Withdrawal by Subject                 0                 0                 1                 1  



  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.
One participant from Arm B (GBM) was removed from analysis, aside from the review of adverse events, due to later determining she did not meet eligibility requirements as a result of prior stereotatic radiosurgery received prior to starting the study.

Reporting Groups
  Description
Arm A Bevacizumab-naive Bevacizumab-naive participants
Arm B Bevacizumab-treated Bevacizumab-treated participants
Total Total of all reporting groups

Baseline Measures
    Arm A Bevacizumab-naive     Arm B Bevacizumab-treated     Total  
Number of Participants  
[units: participants]
  22     14     36  
Age  
[units: years]
Median ( Full Range )
  54  
  ( 28 to 75 )  
  52  
  ( 32 to 70 )  
  52  
  ( 28 to 75 )  
Gender  
[units: participants]
     
Female     15     3     18  
Male     7     11     18  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     1     0     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     19     11     30  
More than one race     1     0     1  
Unknown or Not Reported     1     3     4  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     1     1  
Not Hispanic or Latino     21     12     33  
Unknown or Not Reported     1     1     2  
Karnofsky Performance Status [1]
[units: Units on a scale]
Median ( Full Range )
  90  
  ( 60 to 100 )  
  90  
  ( 60 to 100 )  
  90  
  ( 60 to 100 )  
[1] Karnofsky Performance Status ranges from 0 (Dead) to 100 (Normal, no complaints, no evidence of disease) in increments of 10. This was measured at baseline, prior to any treatment on study.



  Outcome Measures
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1.  Primary:   6-Month Progression Free Survival   [ Time Frame: Six months ]

2.  Primary:   3-Month Progression Free Survival   [ Time Frame: 3 months ]

3.  Secondary:   Proportion of Participants Experiencing Stable Disease (SD) as Their Best Radiographic Response   [ Time Frame: 2 years ]

4.  Secondary:   Overall Survival   [ Time Frame: 2 years ]

5.  Secondary:   Time-to-tumor Progression   [ Time Frame: 2 years ]

6.  Secondary:   Safety Profile as Summarized With Descriptive Statistics (Using Toxicity Data Gathered on Trial)   [ Time Frame: 2 years ]

7.  Other Pre-specified:   Exploratory Objective #1: Progression-free Survival at 3- and 6-months for Participants With Recurrent Anaplastic Gliomas (AG)   [ Time Frame: Arm A - 6 months; Arm B - 3 months ]

8.  Other Pre-specified:   Exploratory Objective #2: Determination if Any Correlation Exists Between Patient Outcomes (Survival, PFS3, PFS6) and Tumor Genotype and/or Expression Profile   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Other Pre-specified:   Exploratory Objective #3: Determination if Any Correlation Exists Between Patient Outcomes (Survival, PFS3, PFS6) and Serum Angiogenic Peptides, Circulating Endothelial Cells, and/or Circulating Progenitor Cells   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Other Pre-specified:   Exploratory Objective #4: Determination if Any Correlation Exists Between Patient Outcomes (Survival, PFS3, PFS6) and Perfusion MRI, Diffusion MRI   [ Time Frame: 2 years ]
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
The trial intended to enroll 14 participants onto Arm A GBM, but only 10 enrolled due to futility. In addition, 10 AG participants were to be enrolled onto each Arm as exploratory cohorts, but again due to futility only 4 enrolled onto Arm B.


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Patrick Y. Wen, MD
Organization: Dana-Farber Cancer Institute
phone: 6176322166
e-mail: pwen@partners.org


No publications provided


Responsible Party: Patrick Y. Wen, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01380782     History of Changes
Other Study ID Numbers: 11-055, BIBF 1199.94
Study First Received: June 21, 2011
Results First Received: July 14, 2014
Last Updated: August 15, 2014
Health Authority: United States: Food and Drug Administration