drugset / Trial / NCT02272777
A Study of Imatinib and Nilotinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The extension study followed the core study CAMN107ECN02 (NCT01275196). which is an open-label, two armed study. All patients enrolled in this extension study were able to benefit from the treatment given in CAMN107ECN02 per investigator's evaluation. Therefore, in this extension study patient continued treatment of the drug (imatinib or nilotinib) which they were taking at the end of CAMN107ECN02. Treatment arms in CAMN107ECN02 were retained. As long as EC approval and agreement from investigators were obtained, the selected sites for CAMN107ECN02 were applied in this extension study.
Timeline
- Start
- 2014-07-17
- Primary completion
- 2017-01-30
- Completion
- 2017-01-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Imatinib | Small molecule | 300 mg | — |
| Comparator | Imatinib | Small molecule | 400 mg | — |
| Comparator | Imatinib | Small molecule | 600 mg | — |
| Subject | Nilotinib | Small molecule | 300 mg | Oral |
| Subject | Nilotinib | Small molecule | 400 mg | Oral |