Status:
NO_LONGER_AVAILABLE
Expanded Access Program of AMN107 in Imatinib-resistant or Intolerant Adult Patients With Chronic Myeloid Leukemia
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18+ years
Brief Summary
This study will further evaluate if AMN107 is safe in adults with chronic myeloid leukemia who are resistant or intolerant to imatinib and to provide patients access to this new drug until the drug be...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Imatinib-resistant or -intolerant Philadelphia chromosome-positive chronic myeloid leukemia in blast crisis, accelerated phase, or chronic phase.
- Chronic myeloid leukemia patients who have been treated with an investigational tyrosine kinase inhibitor.
- Laboratory values within normal limits.
- Exclusion criteria:
- Impaired cardiac function.
- Acute or chronic liver or renal disease considered unrelated to tumor.
- Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol.
- Patients who are currently receiving treatment with any of the medications that have the potential to prolong the QT interval or to inhibit the metabolism of AMN107 (CYP3A4/5 inhibitors).
- Patients with a history of another malignancy that is currently clinically significant or currently requires active intervention.
- Other protocol-defined inclusion/exclusion criteria may apply.
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00302016
Start Date
January 1 2006
Last Update
August 26 2011
Active Locations (270)
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1
University of South Alabama Cancer Research Institute
Mobile, Alabama, United States, 36693
2
Arizona Cancer Center
Tucson, Arizona, United States, 85724
3
City of Hope National Medical Center
Duarte, California, United States, 91010
4
Antelope Valley Cancer Center
Lancaster, California, United States, 93534