Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00124748
Status:
TERMINATED
Last Update Posted:
2012-02-03
First Post:
2005-07-27
Brief Title:
Efficacy of 400 Mg Versus 800 Mg Imatinib in Chronic Myeloid Leukemia in Chronic Phase Patients - TOPS Tyrosine Kinase Inhibitor Optimization and Selectivity
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Randomized Open-label Study of 400 mg Versus 800 mg of Imatinib Mesylate in Patients With Newly Diagnosed Previously Untreated Chronic Myeloid Leukemia in Chronic Phase CML-CP Using Molecular Endpoints
Status:
TERMINATED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was prematurely discontinued because no improvement was observed in the 800mg dose compared to 400mg dose
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TOPS
Brief Summary:
This study investigated the safety and efficacy of 400mg Versus 800mg imatinib in patients with newly diagnosed previously untreated chronic myeloid leukemia in chronic phase CML-CP using molecular endpoints
Detailed Description:
None
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