Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2026-01-02 @ 12:33 AM
Study NCT ID:
NCT00423735
Status:
COMPLETED
Last Update Posted:
2019-07-24
First Post:
2007-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dasatinib in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2009-00744 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CDR0000526070 | None | None | View | |
| RTOG 0627 | OTHER | NRG Oncology | View | |
| RTOG-0627 | OTHER | CTEP | View | |
| U10CA180868 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10CA021661 | NIH | None | https://reporter.nih.gov/quic… | View |