Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003359
Status:
COMPLETED
Last Update Posted:
2013-06-25
First Post:
1999-11-01
Brief Title:
T138067 Sodium in Treating Patients With Advanced Refractory Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
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:
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-G98-1443 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066341 | REGISTRY | None | None |
| TULA-T9801 | None | None | None |