Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054249
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2003-02-05
Brief Title:
T900607 in Treating Patients With Gastroesophageal Junction Cancer
Sponsor:
University Hospitals Seidman Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study Of Intravenous T900607-Sodium In Subjects With Previously Treated Gastric Carcinoma
Status:
COMPLETED
Status Verified Date:
2010-09
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 work in different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of T900607 in treating patients who have gastroesophageal junction cancer
PURPOSE Phase II trial to study the effectiveness of T900607 in treating patients who have gastroesophageal junction cancer
Detailed Description:
OBJECTIVES
Determine the response rate complete and partial in patients with previously treated gastric or gastroesophageal junction carcinoma treated with T900607 Gastric carcinoma closed to accrual as of 0204
Determine the duration of response and time to disease progression in patients treated with this drug
Determine the pharmacokinetics of this drug in these patients
Determine the safety profile of this drug in these patients
OUTLINE This is an open-label multicenter study
Patients receive T900607 IV over 1 hour once weekly Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 20-35 patients will be accrued for this study
Determine the response rate complete and partial in patients with previously treated gastric or gastroesophageal junction carcinoma treated with T900607 Gastric carcinoma closed to accrual as of 0204
Determine the duration of response and time to disease progression in patients treated with this drug
Determine the pharmacokinetics of this drug in these patients
Determine the safety profile of this drug in these patients
OUTLINE This is an open-label multicenter study
Patients receive T900607 IV over 1 hour once weekly Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 20-35 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TULA-TULI-1202 | Registry Identifier | PDQ Physician Data Query | None |
| CWRU-060214M | None | None | None |
| CDR0000269917 | REGISTRY | None | None |