drugset / Trial / NCT00905593

Nilotinib in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

NCT00905593

Expanded access Approved for marketing Novartis Pharmaceuticals

Summary

Multi-center, open-label, non-randomized trial to evaluate long-term safety and efficacy of nilotinib. Approximately 20 patients will be enrolled in this trial at 3 centers in Mexico, which means all ongoing patients participating on \[CAMN107A2109\] excluding discontinued patients. During this study, patients will receive nilotinib orally, at a dose of 400 mg b.i.d. Patients will normally receive nilotinib on an outpatient basis. This trial will have a maximum of 24 months of follow-up time.

Timeline

Start
2008-09
Primary completion
2011-04
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Nilotinib Small molecule 400 mg Oral