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

This study has been completed.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00264160

Purpose

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	Intervention	Phase
Leukemia, Myeloid, Chronic	Drug: AMN107	Phase II Phase III

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Imatinib Imatinib mesylate 4-Methyl-N-(3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-pyridin-3-ylpyrimidin-2-yl)amino)benzamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Oral AMN107 in Adults With Chronic Myelogenous Leukemia Resistant and/or Intolerant to Imatinib Mesylate Therapy

Further study details as provided by Novartis:

Primary Outcome Measures:

Cytogenetic response within 12 months

Secondary Outcome Measures:

To determine the rate of hematologic response at 12 months
To determine the rate of molecular response at 12 months
To evaluate the time to cytogenetic and molecular response

Estimated Enrollment:	20
Study Start Date:	June 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264160

Locations

Israel

Haifa, Israel

Jerusalem, Israel

TelHashomer, Israel

Petach Tikva, Israel

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Study ID Numbers:	CAMN107AIL01
Study First Received:	December 9, 2005
Last Updated:	May 1, 2008
ClinicalTrials.gov Identifier:	NCT00264160
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Novartis:

AMN107
CML
Bcr Abl
cytogenetic response
Chronic Myelogenous Leukemia (CML) patients resistant or intolerant to imatinib mesylate therapy

Study placed in the following topic categories:

Imatinib
Leukemia
Chronic myelogenous leukemia
Hematologic Diseases

Myeloproliferative Disorders
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009