Status:
COMPLETED
Efficacy and Safety of Oral AMN107 in Adults With Chronic Myelogenous Leukemia Resistant and/or Intolerant to Imatinib Mesylate Therapy
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Leukemia, Myeloid, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 mesyla...
Eligibility Criteria
Inclusion
- Imatinib - resistant or - intolerant Philadelphia chromosome-positive CML in blast crisis, accelerated or chronic phase
- Males or females ≥ 18 years of age
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00264160
Start Date
May 1 2006
End Date
August 1 2009
Last Update
March 6 2017
Active Locations (4)
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1
Novartis Investigative Site
Haifa, Israel
2
Novartis Investigative Site
Jerusalem, Israel
3
Novartis Investigative Site
Petah Tikva, Israel
4
Novartis Investigative Site
Tel Litwinsky, Israel