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


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Imatinib

Gleevec; imatinib mesylate

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

This study is not yet open for patient recruitment.
Verified by Novartis December 2005

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 CML patients that are resistant and/or intolerant to imatinib mesylate therapy.
Condition Intervention Phase
Chronic Mylogenous Leukemia (CML) Patients Resistant or Intolerant to Imatinib Mesylate Therapy
  Drug: AMN107
 Phase II
Phase III

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Novartis:

Study start: March 2006

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
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

Additional protocol-defined inclusion/exclusion criteria may apply

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00264160

Novartis      +41 61 324 1111 
Novartis      +97239201137 

Israel
      Haifa,  Israel

      Jerusalem,  Israel

      TelHashomer,  Israel

      Petach Tikva,  Israel

Study chairs or principal investigators

Novartis,  Study Chair,  Novartis   

More Information

Study ID Numbers:  CAMN107AIL01
Last Updated:  December 22, 2005
Record first received:  December 9, 2005
ClinicalTrials.gov Identifier:  NCT00264160
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
ClinicalTrials.gov processed this record on 2006-01-10


Source: ClinicalTrials.gov
Cache Date: January 11, 2006


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Page Updated: September 6, 2005
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