Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00519090
Status:
TERMINATED
Last Update Posted:
2011-11-06
First Post:
2007-08-17
Brief Title:
Nilotinib vs Imatinib in Adult Patients With Philadelphia Ph Chronic Myelogenous Leukemia in Chronic Phase CML-CP
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase III Randomized Open- Label Multi-center Study of Nilotinib Versus Imatinib in Adult Patients With Ph Chronic Myelogenous Leukemia in Chronic Phase CML-CP Who Have a Suboptimal Cytogenetic Response CyR on Imatinib
Status:
TERMINATED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was terminated due to limited enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENEST
Brief Summary:
In this study the efficacy and safety of nilotinib 400 mg twice daily will be compared with imatinib 400 mg twice daily in patients with a suboptimal response to imatinib for their Philadelphia chromosome-positive Ph Chronic Myelogenous Leukemia in the chronic phase CML-CP
Detailed Description:
This trial was to evaluate the CCyR rate at 12 months of nilotinib therapy when compared to imatinib treatment in patients with suboptimal response to imatinib The patients were stratified by prior duration of initial imatinib treatment and were randomized to receive either 400 mgtwice daily of continuous nilotinib or imatinib treatment The first stratum patients were treated with imatinib 6 to 12 months and having at least a minimal cytogenetic but no partial cytogenetic response and the second stratum patients were treated with imatinib 12 months to 18 months and having partial cytogenetic response PCyR but no CCyR
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