NCT00423735

Dasatinib in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma

Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well dasatinib works in treating patients with glioblastoma multiforme or gliosarcoma that has come back. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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. OUTLINE: 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.

Conditions

• Adult Giant Cell Glioblastoma
• Adult Glioblastoma
• Adult Gliosarcoma
• Recurrent Adult Brain Neoplasm

Interventions

Type	Name	Description
DRUG	Dasatinib	Given PO
OTHER	Pharmacological Study	Correlative studies

Timeline

• Start date: 2007-01-24
• Primary completion: 2011-03-09
• Completion: 2018-09-04
• First posted: 2007-01-18
• Last updated: 2019-07-24
• Results posted: 2015-01-06

Locations

188 sites across 3 countries: United States, Canada, Saudi Arabia