Dasatinib in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma
Adult Giant Cell Glioblastoma
Recurrent Adult Brain Neoplasm
Other: Pharmacological Study
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme|
- Number of Patients Achieving 6-month Progression-free Survival (6mPFS) [ Time Frame: 6 months ]This study utilized a two-stage phase II design (Stage 1B and 2). The primary endpoint of 6-month progression-free survival (6mPFS) would be assessed based on the patients combined from 1B and 2 if the study continued to Stage 2. Null hypothesis = 11%; alternative hypothesis = 25%. Simon's minmax 2-stage design was used with type I and type II error both set at 10%. If the first stage met its criteria (see secondary outcome measure), then accrual would continue, otherwise there would be no further accrual and the alternative hypothesis would be rejected. Following Stage 2 accrual completion and 6 months of follow-up, if 9 or more patients were alive without progression by 6 months, the null hypothesis would be rejected in favor of the alternative.
- Number of Patients Achieving Objective Response (Partial or Complete Response) OR 6-month Progression-free Survival (6mPFS) [ Time Frame: 6 months ]Study design and efficacy determination uses the hybrid endpoint of 6mPFS or complete/partial response of any duration prior to or at 6 months. Null hypothesis = 11%; alternative hypothesis = 25%. Simon's minmax 2-stage design was used with type I and type II error both set at 10%. Stage 1 and 1B: If 2 or fewer patients were alive and progression-free at 6 months or achieved complete/partial response, then there would be no further accrual and the alternative hypothesis would be rejected. Otherwise accrual would continue to a total of 50 analyzable patients to address the primary endpoint.
- Overall Survival Distribution [ Time Frame: 6 months ]The Kaplan-Meier method will be used.
- Rates of Treatment Adverse Events [ Time Frame: 6 months ]
- Objective Response Rates [Complete Response (CR), Partial Response (PR), Stable Disease, Progression] [ Time Frame: 6 months ]
- PFS Distribution [ Time Frame: 6 months ]The Kaplan-Meier method will be used.
|Study Start Date:||January 2007|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Experimental: Treatment (dasatinib)
Patients receive dasatinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.
Other Names:Other: Pharmacological Study
I. To determine the therapeutic efficacy of dasatinib in all patients (i.e., stages 1B and 2 combined) with recurrent/progressive glioblastoma (GBM) as measured by 6-month progression-free survival.
I. To determine the therapeutic efficacy of dasatinib for stage 1B patients with recurrent/progressive GBM as measured by a hybrid endpoint of 6-month progression-free survival OR objective response of (complete response [CR] or partial response [PR]) rate.
II. To determine patient overall survival. III. To determine the toxicity of dasatinib in the treatment of patients with GBM.
IV. To determine radiographic response rate to treatment. V. To determine patient progression-free survival. VI. To explore molecular correlates of clinical outcome. VII. To explore pharmacokinetic correlates of dosing, toxicity, and efficacy.
Patients receive dasatinib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.
After the completion of study treatment, patients are followed up periodically.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00423735
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|Principal Investigator:||Andrew Lassman||NRG Oncology|