Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068380
Status:
COMPLETED
Last Update Posted:
2018-07-11
First Post:
2003-09-10
Brief Title:
A Phase II Trial of STI571 in the Treatment of Metastatic Gastric Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of STI571 in the Treatment of Metastatic Gastric Cancer
Status:
COMPLETED
Status Verified Date:
2018-06
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:
Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth This phase II trial is studying how well imatinib mesylate works in treating patients with refractory metastatic andor unresectable stomach or gastroesophageal junction cancer
Detailed Description:
PRIMARY OBJECTIVES
I To determine the response rate time to tumor progression and overall survival in patients with metastatic gastric cancer treated with STI571 who have failed one chemotherapy regimen for metastatic disease
II To assess the toxicities of STI571 in these patients III To obtain preliminary data on molecular correlates to determine clinical efficacy and toxicity
OUTLINE This is a multicenter study Patients are stratified according to risk good risk chemonaïve vs poor risk 1 prior chemotherapy regimen
Patients receive oral imatinib mesylate twice daily on days 1-28 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed for 30 days
PROJECTED ACCRUAL A total of 21-41 patients will be accrued for this study within 1-15 years
I To determine the response rate time to tumor progression and overall survival in patients with metastatic gastric cancer treated with STI571 who have failed one chemotherapy regimen for metastatic disease
II To assess the toxicities of STI571 in these patients III To obtain preliminary data on molecular correlates to determine clinical efficacy and toxicity
OUTLINE This is a multicenter study Patients are stratified according to risk good risk chemonaïve vs poor risk 1 prior chemotherapy regimen
Patients receive oral imatinib mesylate twice daily on days 1-28 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed for 30 days
PROJECTED ACCRUAL A total of 21-41 patients will be accrued for this study within 1-15 years
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 | None | httpsreporternihgovquickSearchN01CM62209 |
| 5734 | None | None | None |