Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00397787
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2006-11-09
Brief Title:
Sunitinib in Treating Patients With Metastatic Pancreatic Cancer That Progressed After First-Line Therapy With Gemcitabine
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Sunitinib Malate SU11248 NSC 736511 IND 74019 in Patients With Previously Treated Pancreatic Adenocarcinoma With Measurable Metastatic Disease Following Progression on Front-Line Gemcitabine-Based Therapy
Status:
COMPLETED
Status Verified Date:
2013-06
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 is studying how well sunitinib works in treating patients with metastatic pancreatic cancer that progressed after first-line therapy with gemcitabine Sunitinib may stop the growth of pancreatic cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To determine the response rate to sunitinib malate in patients with previously treated metastatic pancreatic adenocarcinoma
SECONDARY OBJECTIVES
I To determine the duration of response progression-free survival and overall survival of sunitinib malate in patients with previously treated metastatic pancreatic adenocarcinoma
II To determine the safety of sunitinib malate in patients with previously treated metastatic pancreatic adenocarcinoma
OUTLINE This is a multicenter nonrandomized study
Patients receive oral sunitinib malate daily on days 1-28 Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
After completion of study patients are followed every 3 months until 2 years from study entry or until disease progression
I To determine the response rate to sunitinib malate in patients with previously treated metastatic pancreatic adenocarcinoma
SECONDARY OBJECTIVES
I To determine the duration of response progression-free survival and overall survival of sunitinib malate in patients with previously treated metastatic pancreatic adenocarcinoma
II To determine the safety of sunitinib malate in patients with previously treated metastatic pancreatic adenocarcinoma
OUTLINE This is a multicenter nonrandomized study
Patients receive oral sunitinib malate daily on days 1-28 Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
After completion of study patients are followed every 3 months until 2 years from study entry or until disease progression
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 |
|---|---|---|---|
| U10CA031946 | NIH | None | httpsreporternihgovquickSearchU10CA031946 |
| CALGB-80603 | None | None | None |