Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054262
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2003-02-05
Brief Title:
T900607 in Treating Patients With Unresectable Liver 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 Chemotherapy-Naive Unresectable Hepatocellular 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 use 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 unresectable liver cancer
PURPOSE Phase II trial to study the effectiveness of T900607 in treating patients who have unresectable liver cancer
Detailed Description:
OBJECTIVES
Determine the complete and partial response rates of patients with chemotherapy-naïve unresectable hepatocellular carcinoma treated with T900607
Determine the efficacy of this drug in terms of duration of response and time to disease progression in these patients
Determine the pharmacokinetics of this drug in these patients
Determine the safety profile of this drug in these patients
OUTLINE This is a 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 complete and partial response rates of patients with chemotherapy-naïve unresectable hepatocellular carcinoma treated with T900607
Determine the efficacy of this drug in terms of duration of response and time to disease progression in these patients
Determine the pharmacokinetics of this drug in these patients
Determine the safety profile of this drug in these patients
OUTLINE This is a 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-T-607-004 | Registry Identifier | PDQ Physician Data Query | None |
| CWRU-100211 | None | None | None |
| CDR0000270198 | REGISTRY | None | None |