Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064584
Status:
COMPLETED
Last Update Posted:
2009-03-24
First Post:
2003-07-09
Brief Title:
Safety and Tolerance Study of Oral Doses of CT53518 to Treat Patients With Acute Myelogenous Leukemia AML
Sponsor:
Millennium Pharmaceuticals Inc
Organization:
Millennium Pharmaceuticals Inc
Study Overview
Official Title:
Tolerability and PKPD of Multiple Oral Doses of CT53518 in Patients With Acute Myelogenous Leukemia
Status:
COMPLETED
Status Verified Date:
2009-03
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 the first study of the drug CT53518 when given to humans The purpose of this study is to determine the highest dose of CT53518 that can safely be given to patients with Acute Myelogenous Leukemia AML and to identify the side effects associated with taking the drug The study will evaluate how CT53518 is absorbed broken down and eliminated by the body Additionally the study will evaluate the effects of the drug on a specific type of cell in bone marrow and blood known as a blast
Detailed Description:
This is a Phase 1 open label dose escalating study at five clinical sites to determine dose limiting toxicity DLT maximum tolerated dose MTD pharmacokinetics and the effect on the peripheral and bone marrow blast count of an oral 28-day course of CT53518 in patients with Acute Myelogenous Leukemia AML and myelodysplastic syndrome This study will confirm the tolerability and assess the effects on the peripheral and bone marrow blast count of an oral 28-day course of CT53518 at or near the maximum tolerated dose in patients with AML displaying a specified mutation of the FLT-3 gene internal tandem duplication ITD
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