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

Phase 2

Completed

• Conditions: Leukemia, Myeloid, Chronic
• Interventions: Drug: AMN107

• Registration Number: NCT00264160
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-12-09
• Study First Submitted QC: 2005-12-09
• Study First Posted: 2005-12-12
• Study Start: 2006-05
• Primary Completion: 2008-11
• Study Completion: 2009-08
• Status Verified: 2012-08
• Last Update Submitted: 2017-03-02
• Last Update Posted: 2017-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AMN107	AMN107	-

Primary Outcome Measures

Name	Time	Method
Cytogenetic response within 12 months	Every 6 months for 12 months

Secondary Outcome Measures

Name	Time	Method
To determine the rate of hematologic response at 12 months	Every Visit for 12 months
To determine the rate of molecular response at 12 months	Every 3 months for 12 months
To evaluate the time to cytogenetic and molecular response	At 12 months

Trial Locations

Locations (1)

Novartis Investigative Site; 🇮🇱 Tel Hashomer, Israel