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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.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00264160
First received: December 9, 2005
Last updated: August 6, 2012
Last verified: August 2012
History of Changes
  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 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Cytogenetic response within 12 months [ Time Frame: Every 6 months for 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the rate of hematologic response at 12 months [ Time Frame: Every Visit for 12 months ] [ Designated as safety issue: Yes ]
  • To determine the rate of molecular response at 12 months [ Time Frame: Every 3 months for 12 months ] [ Designated as safety issue: Yes ]
  • To evaluate the time to cytogenetic and molecular response [ Time Frame: At 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: May 2006
Study Completion Date: August 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMN107 Drug: AMN107

  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
Novartis Investigative Site
Haifa, Israel
Novartis Investigative Site
Jerusalem, Israel
Novartis Investigative Site
Petach Tikva, Israel
Novartis Investigative Site
Tel Hashomer, Israel
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00264160     History of Changes
Other Study ID Numbers: CAMN107AIL01
Study First Received: December 9, 2005
Last Updated: August 6, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Novartis:
AMN107
CML
Bcr Abl
 cytogenetic response
Chronic Myelogenous Leukemia (CML)
imatinib mesylate

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
 Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013