Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129948
Status:
TERMINATED
Last Update Posted:
2006-11-03
First Post:
2005-08-10
Brief Title:
Study for Patients With Relapsed or Refractory Acute Myeloid Leukemia AML
Sponsor:
SGX Pharmaceuticals Inc
Organization:
SGX Pharmaceuticals Inc
Study Overview
Official Title:
An Open-Label Single-Arm Multi-Center Phase II Study of Troxatyl Troxacitabine Administered by Continuous Infusion in Patients With Acute Myeloid Leukemia AML in Second Salvage
Status:
TERMINATED
Status Verified Date:
2006-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase 2 single-arm open-label multi-center study to establish the safety and efficacy of Troxatyl troxacitabine administered as a continuous infusion for 5 days to subjects with AML
Detailed Description:
This is a phase 2 single-arm open-label multi-center study to establish the safety and efficacy of Troxatyl troxacitabine administered as a continuous infusion for 5 days to subjects with AML The study will primarily assess the complete response CR rate of a 5-day continuous infusion of troxacitabine at 12 mgm2day given as second salvage therapy in adult patients with AML with secondary objectives to determine the overall relapse-free and event-free survival and remission duration to determine the duration of response to determine the complete response with incomplete platelet recovery CRp rate to evaluate the tolerability and safety of 5-day continuous intravenous IV infusion of troxacitabine and to determine the relationship between troxacitabine plasma concentrations anti-leukemic activity and adverse events Additional cycles of treatment may be given at the investigators discretion provided that the subject does not have progressive disease or experience a dose limiting toxicity Bone marrow transplantation in responding subjects will be allowed
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