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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00264160

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Myeloid, Chronic	Drug: AMN107	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2006

Actual Primary Completion Date :

Nov 1, 2008

Actual Study Completion Date :

Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AMN107	Drug: AMN107

Arm

Intervention/Treatment

Experimental: AMN107

Drug: AMN107

Outcome Measures

Primary Outcome Measures

Cytogenetic response within 12 months [Every 6 months for 12 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country
1	Novartis Investigative Site	Haifa	Israel
2	Novartis Investigative Site	Jerusalem	Israel
3	Novartis Investigative Site	Petach Tikva	Israel
4	Novartis Investigative Site	Tel Hashomer	Israel