Efficacy and Safety of Oral AMN107 in Adults With Chronic Myelogenous Leukemia Resistant and/or Intolerant to Imatinib Mesylate Therapy
Phase 2/Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Leukemia, Myeloid, Chronic
Both
Leukemia, Myeloid, Chronic
Trial Information
Efficacy and Safety of Oral AMN107 in Adults With Chronic Myelogenous Leukemia Resistant and/or Intolerant to Imatinib Mesylate Therapy
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Cytogenetic response within 12 months
Outcome Time Frame:
Every 6 months for 12 months
Safety Issue:
Yes
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
Israel: Israeli Health Ministry Pharmaceutical Administration
Study ID:
CAMN107AIL01
NCT ID:
NCT00264160
Start Date:
May 2006
Completion Date:
August 2009
Related Keywords:
- Leukemia, Myeloid, Chronic
- AMN107
- CML
- Bcr Abl
- cytogenetic response
- Chronic Myelogenous Leukemia (CML)
- imatinib mesylate
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
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