Nilotinib vs Imatinib in Adult Patients With Philadelphia (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) (ENEST)
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|ClinicalTrials.gov Identifier: NCT00519090|
Recruitment Status : Terminated (This study was terminated due to limited enrollment.)
First Posted : August 21, 2007
Results First Posted : May 10, 2011
Last Update Posted : November 7, 2011
|Condition or disease||Intervention/treatment||Phase|
|Myelogenous Leukemia||Drug: Imatinib Drug: Nilotinib (AMN107)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||October 2008|
|Experimental: Nilotinib (AMN107)||
Drug: Nilotinib (AMN107)
Administered orally as a single agent on a continuous daily schedule of 400 mg bid (2 x 200 mg twice daily) without food. Once cycle comprised of 28 days.
|Active Comparator: Imatinib||
Administered orally as a single agent on a continuous daily schedule given 400 mg bid (twice daily) with food. One cycle comprised of 28 days.
- Complete Cytogenetic Response Rate(CCyR) in Patients Who Had a Suboptimal Cytogenetic Response on Imatinib [ Time Frame: 12 months ]Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.
- Durable Complete Cytogenetic Response Rate [ Time Frame: 24 months ]Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00519090
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|