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Dasatinib in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00423735
First Posted: January 18, 2007
Last Update Posted: May 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
Results First Submitted: June 19, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Recurrent Adult Brain Neoplasm
Interventions: Drug: Dasatinib
Other: Pharmacological Study

  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
Per protocol criteria, the study did not continue to Stage 2 and therefore no patients were accrued to this arm.

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 
Overall Participants Analyzed 
[Units: Participants]
 21   29   0   50 
Age 
[Units: Years]
Median (Full Range)
 51 
 (33 to 81) 
 54 
 (26 to 75) 
    54 
 (26 to 81) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      11  52.4%      12  41.4%         23  46.0% 
Male      10  47.6%      17  58.6%         27  54.0% 


  Outcome Measures
  Show All Outcome Measures

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

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

3.  Secondary:   Overall Survival   [ Time Frame: Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.) ]

4.  Secondary:   Treatment Response Rates at Six Months   [ Time Frame: From registration to 6 months ]

5.  Secondary:   Progression-free Survival   [ Time Frame: Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.) ]

6.  Secondary:   Rate of Adverse Events   [ Time Frame: Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.) ]

7.  Secondary:   Correlation of Molecular Markers and Tumor Response   [ Time Frame: From registration to 6 months ]

8.  Secondary:   Correlation of Pharmacokinetic Data With Dosing, Toxicity, and Efficacy   [ Time Frame: Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.) ]


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00423735     History of Changes
Other Study ID Numbers: NCI-2009-00744
NCI-2009-00744 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000526070
RTOG 0627 ( Other Identifier: NRG Oncology )
RTOG-0627 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA021661 ( U.S. NIH Grant/Contract )
First Submitted: January 16, 2007
First Posted: January 18, 2007
Results First Submitted: June 19, 2014
Results First Posted: January 6, 2015
Last Update Posted: May 23, 2017