Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017043
Status:
COMPLETED
Last Update Posted:
2013-04-05
First Post:
2001-06-06
Brief Title:
BMS-247550 in Treating Patients With Metastatic Stomach Cancer Previously Treated With Chemotherapy
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
A Phase II Study of Epothilone Analog BMS-247550 in Patients With Metastatic Gastric Adenocarcinoma Previously Treated With a Taxane
Status:
COMPLETED
Status Verified Date:
2013-04
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of BMS-247550 in treating patients who have metastatic stomach cancer previously treated with chemotherapy
PURPOSE Phase II trial to study the effectiveness of BMS-247550 in treating patients who have metastatic stomach cancer previously treated with chemotherapy
Detailed Description:
OBJECTIVES
Determine the clinical activity of BMS-247550 in terms of response rate in patients with previously treated metastatic gastric adenocarcinoma
Determine the safety of this drug in these patients
Assess the response duration time to progression and survival of patients treated with this drug
OUTLINE This is a multicenter study
Patients receive BMS-247550 IV over 1 hour on day 1 Treatment repeats every 21 days for 2-18 courses in the absence of disease progression or unacceptable toxicity Patients with a complete response CR receive 4 additional courses after confirmation of CR
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 21-58 patients will be accrued for this study within 1 year
Determine the clinical activity of BMS-247550 in terms of response rate in patients with previously treated metastatic gastric adenocarcinoma
Determine the safety of this drug in these patients
Assess the response duration time to progression and survival of patients treated with this drug
OUTLINE This is a multicenter study
Patients receive BMS-247550 IV over 1 hour on day 1 Treatment repeats every 21 days for 2-18 courses in the absence of disease progression or unacceptable toxicity Patients with a complete response CR receive 4 additional courses after confirmation of CR
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 21-58 patients will be accrued for this study within 1 year
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-G01-1949 | None | None | None |
| BMS-MSKCC-01011 | None | None | None |
| MSKCC-01011 | None | None | None |