Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088231
Status:
COMPLETED
Last Update Posted:
2012-01-20
First Post:
2004-07-22
Brief Title:
PTK 787 and Gleevec in Patients With AML AMM and CML-BP
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Ph III Study of PTK 787 Vatalanib and Gleevec Imatinib in Patients With Refractory Acute Myelogenous Leukemia AML Agnogenic Myeloid Metaplasia AMM and Chronic Myelogenous Leukemia- Blastic Phase CML-BP
Status:
COMPLETED
Status Verified Date:
2012-01
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:
The goal of this clinical research study is to find the highest safe doses of PTK 787 vatalanib and Gleevec imatinib mesylate that can be given to treat Chronic Myelogenous Leukemia-Blastic Phase CML-BP Refractory Acute Myelogenous Leukemia AML or Agnogenic Myeloid Metaplasia AMM Another goal is to see how effective this combination treatment is
Detailed Description:
Rationale The purpose of this study is to combine PTK-787 a potent orally vascular endothelial growth factor VEGF receptor inhibitor in disorders where VEGF is known to be involved in the pathophysiology with Imatinib mesylate IM a protein-tyrosine kinase inhibitor of abl Bcr-Abl platelet derived growth factor PDGF and c-Kit in same disorders where these kinases are believed to be important The potential synergy between oral agents that inhibit these kinases in disorders where each of the two agents have some but inadequate single agent activity is being studied in this protocol We will also have an opportunity to assess if there is any correlation between response and individual kinase mutations eg c-Kit in patients with AML If improved outcomes are observed further studies will be indicated to investigate which if either agent is predominantly responsible for such a benefit - these studies will be facilitated by the availability of more potent eg AMN107 as an abl inhibitor Bevacizumab AG013736 as VEGF inhibitors agents which will help to define the relative importance of the various inhibitory activities
Objectives To determine the maximum tolerated doses MTD and pharmacokinetics PK of PTK 787 and imatinib mesylate when given in combination to patients with refractory acute myelogenous leukemia AML agnogenic myeloid metaplasia AMM and chronic myelogenous leukemia in blastic phase CML-BP
To determine the efficacy response rate survival time to progression time to treatment failure duration of response of the MTD in these study populations
Objectives To determine the maximum tolerated doses MTD and pharmacokinetics PK of PTK 787 and imatinib mesylate when given in combination to patients with refractory acute myelogenous leukemia AML agnogenic myeloid metaplasia AMM and chronic myelogenous leukemia in blastic phase CML-BP
To determine the efficacy response rate survival time to progression time to treatment failure duration of response of the MTD in these study populations
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