Dasatinib in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00423735
First received: January 16, 2007
Last updated: December 18, 2014
Last verified: June 2014
Results First Received: June 19, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Recurrent Adult Brain Tumor
Intervention: Drug: dasatinib

  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
Stage 1: Dasatinib 200mg/Day Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity
Stage 1B: Dasatinib up to 400mg/Day Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
Stage 2: Dasatinib up to 400mg/Day Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.

Participant Flow:   Overall Study
    Stage 1: Dasatinib 200mg/Day     Stage 1B: Dasatinib up to 400mg/Day     Stage 2: Dasatinib up to 400mg/Day  
STARTED     29     35     0  
COMPLETED     21     29     0  
NOT COMPLETED     8     6     0  
Ineligible / No protocol treatment                 8                 6                 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.
Eligible patients who started protocol treatment.

Reporting Groups
  Description
Stage 1: Dasatinib 200mg/Day Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.
Stage 1B: Dasatinib up to 400mg/Day Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
Stage 2: Dasatinib up to 400mg/Day Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
Total Total of all reporting groups

Baseline Measures
    Stage 1: Dasatinib 200mg/Day     Stage 1B: Dasatinib up to 400mg/Day     Stage 2: Dasatinib up to 400mg/Day     Total  
Number of Participants  
[units: participants]
  21     29     0     50  
Age  
[units: years]
Median ( Full Range )
  51  
  ( 33 to 81 )  
  54  
  ( 26 to 75 )  
   
   
  54  
  ( 26 to 81 )  
Gender  
[units: participants]
       
Female     11     12         23  
Male     10     17         27  



  Outcome Measures
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1.  Primary:   Number of Patients Achieving 6-month Progression-free Survival (6mPFS)   [ Time Frame: 6 months ]

2.  Secondary:   Number of Patients Achieving Objective Response (Partial or Complete Response) OR 6-month Progression-free Survival (6mPFS)   [ Time Frame: 6 months ]

3.  Secondary:   Overall Survival Distribution   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Rates of Treatment Adverse Events   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Objective Response Rates [Complete Response (CR), Partial Response (PR), Stable Disease, Progression]   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   PFS Distribution   [ Time Frame: 6 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
Designed as a 2-stage study. The protocol was amended after Stage 1 to add Stage 1B allowing intra-patient escalation. Per protocol criteria, the study did not continue to Stage 2.


  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 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.
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: Wendy Seiferheld
Organization: Radiation Therapy Oncology Group (RTOG)
e-mail: wseiferheld@acr.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00423735     History of Changes
Other Study ID Numbers: NCI-2009-00744, NCI-2009-00744, CDR0000526070, RTOG 0627, RTOG-0627, U10CA021661
Study First Received: January 16, 2007
Results First Received: June 19, 2014
Last Updated: December 18, 2014
Health Authority: United States: Food and Drug Administration