Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00423735
Status:
COMPLETED
Last Update Posted:
2019-07-24
First Post:
2007-01-16
Brief Title:
Dasatinib in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
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 ie stages 1B and 2 combined with recurrentprogressive 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 recurrentprogressive 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 ie stages 1B and 2 combined with recurrentprogressive 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 recurrentprogressive 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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA021661 | NIH | CTEP | httpsreporternihgovquickSearchU10CA021661 |
| NCI-2009-00744 | REGISTRY | None | None |
| CDR0000526070 | None | None | None |
| RTOG 0627 | OTHER | None | None |
| RTOG-0627 | OTHER | None | None |
| U10CA180868 | NIH | None | None |