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Bosutinib in Adult Patients With Recurrent Glioblastoma

This study has been completed.
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Pfizer
Information provided by (Responsible Party):
Tracy T. Batchelor, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01331291
First received: March 28, 2011
Last updated: June 23, 2016
Last verified: June 2016
Results First Received: June 9, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Glioblastoma
Intervention: Drug: bosutinib

  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
Arm A

Patients who are surgical candidates

bosutinib: Taken orally

Arm B

Patients that are not surgical candidates

bosutinib: Taken orally


Participant Flow:   Overall Study
    Arm A   Arm B
STARTED   2   9 
COMPLETED   0   0 
NOT COMPLETED   2   9 
Lack of Efficacy                2                8 
Death                0                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.
No text entered.

Reporting Groups
  Description
Arm A

Patients who are surgical candidates

bosutinib: Taken orally

Arm B

Patients that are not surgical candidates

bosutinib: Taken orally

Total Total of all reporting groups

Baseline Measures
   Arm A   Arm B   Total 
Overall Participants Analyzed 
[Units: Participants]
 2   9   11 
Age 
[Units: Years]
Median (Full Range)
 60 
 (58 to 62) 
 44 
 (36 to 62) 
 52 
 (36 to 62) 
Gender 
[Units: Participants]
     
Female   0   4   4 
Male   2   5   7 
Prior Surgery [1] 
[Units: Participants]
     
Gross Total Resection   1   6   7 
Sub total Resection   0   3   3 
No prior surgery   1   0   1 
[1] Surgery done at time of diagnosis with glioblastoma
Karnofsky Performance Status (KPS) [1] 
[Units: Units on a scale]
Median (Full Range)
 80 
 (70 to 90) 
 90 
 (70 to 90) 
 90 
 (70 to 90) 
[1] A standard way of measuring the ability of cancer patients to perform ordinary tasks. The Karnofsky Performance Status scores range from 0 to 100. A higher score means the patient is better able to carry out daily activities. (0 being 'Dead' and 100 being 'Normal, no complaints; no evidence of disease'.)
Prior chemoradiation [1] 
[Units: Participants]
 2   9   11 
[1] Number of patients who previously received standard, initial therapy with temozolomide and radiation at diagnosis


  Outcome Measures
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1.  Primary:   Progression-Free Survival   [ Time Frame: 2 years ]

2.  Secondary:   Intratumoral Concentration   [ Time Frame: 2 years ]

3.  Secondary:   Safety Profile   [ Time Frame: 2 years ]

4.  Secondary:   Anti-tumor Response   [ Time Frame: 2 years ]


  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
This study met pre-specified criteria for early closure, as all 9 patients enrolled on Arm B demonstrated disease progression within 6 months.


  More Information
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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: Tracy T. Batchelor, MD
Organization: Massachusetts General Hospital
phone: 617-643-1938
e-mail: tbatchelor@mgh.harvard.edu


Publications:

Responsible Party: Tracy T. Batchelor, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01331291     History of Changes
Other Study ID Numbers: 10-190
Study First Received: March 28, 2011
Results First Received: June 9, 2016
Last Updated: June 23, 2016
Health Authority: United States: Food and Drug Administration