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

Novartis

Status and phase: Completed; Phase 3; Phase 2

Conditions: Leukemia, Myeloid, Chronic

Treatments: Drug: AMN107

Study type: Interventional

Funder types: Industry

Identifiers

NCT00264160

CAMN107AIL01

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

AMN107

Experimental group

Treatment:

Drug: AMN107