Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00474812
Status:
COMPLETED
Last Update Posted:
2015-05-05
First Post:
2007-05-16
Brief Title:
Dasatinib in Treating Patients With Metastatic Pancreatic Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Dasatinib BMS-354825 in Patients With Metastatic Adenocarcinoma of the Pancreas
Status:
COMPLETED
Status Verified Date:
2013-11
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:
Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth This phase II trial is studying how well dasatinib works in treating patients with metastatic pancreatic cancer
Detailed Description:
PRIMARY OBJECTIVE
I Determine the overall survival including median survival of patients with metastatic adenocarcinoma of the pancreas treated with dasatinib
SECONDARY OBJECTIVES
I Determine the effects of this drug on quantities of circulating tumor cells in these patients
II Determine the time to progression in patients treated with this drug III Determine pre- and post-drug fat-free mass and gait speed in patients treated with this drug
IV Evaluate the toxicity of this drug in these patients V Evaluate objective response rate in patients treated with this drug
OUTLINE This is an open-label multicenter study
Patients receive oral dasatinib twice daily on days 1-28 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Patients undergo blood collection at baseline and during days 25-31 Samples are analyzed for quantification of circulating tumor cells Patients also undergo analysis of fat-free mass and gait speed at baseline and at 1 2 and 6 months
After completion of study treatment patients are followed periodically
I Determine the overall survival including median survival of patients with metastatic adenocarcinoma of the pancreas treated with dasatinib
SECONDARY OBJECTIVES
I Determine the effects of this drug on quantities of circulating tumor cells in these patients
II Determine the time to progression in patients treated with this drug III Determine pre- and post-drug fat-free mass and gait speed in patients treated with this drug
IV Evaluate the toxicity of this drug in these patients V Evaluate objective response rate in patients treated with this drug
OUTLINE This is an open-label multicenter study
Patients receive oral dasatinib twice daily on days 1-28 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Patients undergo blood collection at baseline and during days 25-31 Samples are analyzed for quantification of circulating tumor cells Patients also undergo analysis of fat-free mass and gait speed at baseline and at 1 2 and 6 months
After completion of study treatment patients are followed 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 |
|---|---|---|---|
| NCI-2009-00228 | REGISTRY | None | None |
| CDR0000546554 | None | None | None |
| CASE 5206 | None | None | None |
| CASE 5206 | OTHER | None | None |
| 7828 | OTHER | None | None |
| U01CA062502 | NIH | CTEP | httpsreporternihgovquickSearchU01CA062502 |