Status:
COMPLETED
A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Hematologic Malignancies
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Myelogenous Leukemia
Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this trial is to assess the efficacy, safety, tolerability, biologic activity, and pharmacokinetics of AMN107 in six groups of patients with one of the following conditions: Relapsed/r...
Eligibility Criteria
Inclusion
- Main inclusion criteria include:
- Patients with CML in blast crisis, CML in accelerated phase defined as never in blast crisis phase, or CML in chronic phase defined as never been in blast crisis phase or accelerated phase who have: \*developed progressive disease during therapy with at least 600 mg of imatinib per day, -OR- \*patients with CML on imatinib therapy, at any dose, developing progressive disease and the presence of a genetic mutation likely to result in imatinib resistance -OR- \*have developed an intolerance to imatinib
- Relapsed or refractory Ph+ ALL
- Hypereosinophilic syndrome/chronic eosinophilic leukemia.
- Systemic mastocytosis who have a clinical indication for treatment.
- Prior imatinib therapy for patients with Ph+ ALL, HES/CEL and SM is permitted but is not required
- CML patients who have been treated with an investigational tyrosine kinase inhibitor who otherwise meet the definition of imatinib-resistance or intolerance are eligible
- Written informed consent prior to any study procedures being performed
Exclusion
- Impaired cardiac function
- Patients with severe/chronic or uncontrolled medical conditions (including but not limited to diabetes, infections, GI impairment, CNS infiltration, liver and kidney disease)
- Prior and concomitant use of certain medications (including but not limited to warfarin, chemotherapy, hematopoietic colony-stimulating growth factors, medications that can affect electrocardiogram test results, other investigational drugs )
- Women who are pregnant or breastfeeding
- Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention.
- Patients unwilling to comply with the protocol.
- Known diagnosis of human immunodeficiency virus (HIV) infection
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
507 Patients enrolled
Trial Details
Trial ID
NCT00109707
Start Date
April 1 2005
End Date
September 1 2012
Last Update
June 29 2021
Active Locations (101)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
Stanford University Medical Center
Stanford, California, United States, 94305-5750
3
University of Colorado Hospital
Aurora, Colorado, United States, 80045
4
H. Lee Moffitt Cancer Center & Research Institute Dept.of H. Lee Moffitt
Tampa, Florida, United States, 33612