Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017212
Status:
COMPLETED
Last Update Posted:
2012-05-16
First Post:
2001-06-06
Brief Title:
DX-8951f in Treating Patients With Metastatic Stomach Cancer
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
A Phase II Study Of Intravenous Exatecan Mesylate DX-891F Administered Daily For Five Days Every Three Weeks To Patients With Previously Untreated Metastatic Gastric Cancer
Status:
COMPLETED
Status Verified Date:
2012-05
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 exatecan mesylate in treating patients who have metastatic stomach cancer
PURPOSE Phase II trial to study the effectiveness of exatecan mesylate in treating patients who have metastatic stomach cancer
Detailed Description:
OBJECTIVES
Determine the objective response rate of patients with previously untreated metastatic gastric cancer treated with exatecan mesylate DX-8951f
Determine the time to tumor progression in this patient population when treated with this drug
Determine the survival at 6 and 12 months in this patient population when treated with this drug
Determine the quantitative and qualitative toxic effects of this drug in this patient population
Determine the pharmacokinetics of this drug in the plasma of these patients
OUTLINE This is a multicenter study
Patients receive exatecan mesylate DX-8951f IV over 30 minutes on days 1-5 Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 12 months
Determine the objective response rate of patients with previously untreated metastatic gastric cancer treated with exatecan mesylate DX-8951f
Determine the time to tumor progression in this patient population when treated with this drug
Determine the survival at 6 and 12 months in this patient population when treated with this drug
Determine the quantitative and qualitative toxic effects of this drug in this patient population
Determine the pharmacokinetics of this drug in the plasma of these patients
OUTLINE This is a multicenter study
Patients receive exatecan mesylate DX-8951f IV over 30 minutes on days 1-5 Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 12 months
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 |
|---|---|---|---|
| DAIICHI-8951A-PRT028 | None | None | None |
| SACI-IDD-00-27 | None | None | None |
| UTHSC-0015011134 | None | None | None |