Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2025-12-26 @ 10:04 AM
Study NCT ID:
NCT00003359
Status:
COMPLETED
Last Update Posted:
2013-06-25
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
T138067 Sodium in Treating Patients With Advanced Refractory Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Study Overview
Official Title:
Phase I Dose Escalation Study to Evaluate the Safety of T138067-Sodium in Patients With Advanced Refractory Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of T138067 sodium in treating patients with advanced refractory cancer.
PURPOSE: Phase I trial to study the effectiveness of T138067 sodium in treating patients with advanced refractory cancer.
Detailed Description:
OBJECTIVES: I. Determine the maximum tolerated dose of T138067 sodium that can be given to patients with advanced refractory cancer on a 28-day schedule and establish a dose for further study. II. Evaluate the safety and dose limiting toxicity of T138067 sodium in these patients. III. Determine the pharmacokinetic parameters after a single intravenous dose of this agent in these patients. IV. Obtain safety data and preliminary efficacy information after repetition of single doses of T138067 sodium in these patients.
OUTLINE: This is an open label, dose escalation study. Patients receive T138067 sodium by IV over 3 hours. Patients may be retreated every 4 weeks for up to 6 courses (6 months total) in the absence of disease progression or dose limiting toxicity (DLT). At least 3 patients are treated at each dose level in the absence of DLT. The maximum tolerated dose is defined as the dose level where 2 of 3-6 patients experience DLT.
PROJECTED ACCRUAL: Approximately 3-24 patients will be accrued into this study.
OUTLINE: This is an open label, dose escalation study. Patients receive T138067 sodium by IV over 3 hours. Patients may be retreated every 4 weeks for up to 6 courses (6 months total) in the absence of disease progression or dose limiting toxicity (DLT). At least 3 patients are treated at each dose level in the absence of DLT. The maximum tolerated dose is defined as the dose level where 2 of 3-6 patients experience DLT.
PROJECTED ACCRUAL: Approximately 3-24 patients will be accrued into 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?: