Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459108
Status:
TERMINATED
Last Update Posted:
2018-04-19
First Post:
2007-04-09
Brief Title:
Dasatinib in Treating Patients With Advanced Liver Cancer That Cannot Be Removed by Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Dasatinib BMS-354825 in Advanced Hepatocellular Carcinoma
Status:
TERMINATED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Halted early for futility
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 is studying how well dasatinib works in treating patients with advanced liver cancer that cannot be removed by surgery Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I Determine the progression-free survival PFS rate and response rate complete and partial response at 4 months in patients with unresectable advanced hepatocellular carcinoma treated with dasatinib
SECONDARY OBJECTIVES
I Determine the median PFS and overall survival of patients treated with this drug
II Assess the toxicity and tolerability of this drug in these patients
OUTLINE This is a multicenter study
Patients receive oral dasatinib twice daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 4 weeks and then every 3-6 months thereafter
I Determine the progression-free survival PFS rate and response rate complete and partial response at 4 months in patients with unresectable advanced hepatocellular carcinoma treated with dasatinib
SECONDARY OBJECTIVES
I Determine the median PFS and overall survival of patients treated with this drug
II Assess the toxicity and tolerability of this drug in these patients
OUTLINE This is a multicenter study
Patients receive oral dasatinib twice daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 4 weeks and then every 3-6 months thereafter
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 |
|---|---|---|---|
| N01CM62209 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62209 |
| NCI-2009-00224 | REGISTRY | None | None |
| CDR0000538220 | None | None | None |
| PHII-83 | None | None | None |
| PHII-83 | OTHER | None | None |
| 7792 | OTHER | None | None |
| N01CM62201 | NIH | None | None |