Efficacy and Safety of Oral AMN107 in Adults With Chronic Myelogenous Leukemia Resistant and/or Intolerant to Imatinib Mesylate Therapy

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This open-label, multicenter trial will evaluate the efficacy and safety of treatment with AMN107 in chronic myelogenous leukemia (CML) patients that are resistant and/or intolerant to imatinib mesylate therapy.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Imatinib Mesylate

Criteria

Inclusion Criteria:

• Imatinib - resistant or - intolerant Philadelphia chromosome-positive CML in blast crisis, accelerated or chronic phase

• Males or females ≥ 18 years of age

Exclusion Criteria:

• Impaired cardiac function

• Acute or chronic liver or renal disease

• Use of therapeutic coumadin

• Central nervous system (CNS) infiltration

Additional protocol-defined inclusion/exclusion criteria may apply.