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

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ClinicalTrials.gov Identifier: NCT00264160
Recruitment Status : Completed
First Posted : December 12, 2005
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( 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.

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Chronic Drug: AMN107 Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
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 2006
Actual Primary Completion Date : November 2008
Actual Study Completion Date : August 2009


Arm Intervention/treatment
Experimental: AMN107 Drug: AMN107



Primary Outcome Measures :
  1. Cytogenetic response within 12 months [ Time Frame: Every 6 months for 12 months ]

Secondary Outcome Measures :
  1. To determine the rate of hematologic response at 12 months [ Time Frame: Every Visit for 12 months ]
  2. To determine the rate of molecular response at 12 months [ Time Frame: Every 3 months for 12 months ]
  3. To evaluate the time to cytogenetic and molecular response [ Time Frame: At 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications of Results:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00264160     History of Changes
Other Study ID Numbers: CAMN107AIL01
First Posted: December 12, 2005    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: August 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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 Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action