Expanded Access Program of AMN107 in Imatinib-resistant or Intolerant Adult Patients With Chronic Myeloid Leukemia

NO_LONGER_AVAILABLE

Conditions studied: Chronic Myeloid Leukemia

In brief

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 becomes commercially available.

Key facts

Study ID

NCT00302016

Run by

Novartis Pharmaceuticals

Starts

2006-01-01

Last updated by the study team

2011-08-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Arizona Cancer Center — Tucson, Arizona, United States
• City of Hope National Medical Center — Duarte, California, United States
• Antelope Valley Cancer Center — Lancaster, California, United States
• Stanford University — Palo Alto, California, United States
• University of Colorado — Aurora, Colorado, United States
• Rocky Mountain Cancer Center — Denver, Colorado, United States
• Georgetown University Medical Center-Lombardi Cancer Center — Washington D.C., District of Columbia, United States
• Washington Cancer Institute — Washington D.C., District of Columbia, United States
• Osler Medical Inc./Osler Clinical Research — Melbourne, Florida, United States
• Advanced Medical Specialties — Miami, Florida, United States
• Integrated Community — Orange Park, Florida, United States
• Florida Hospital Cancer Institute — Orlando, Florida, United States
• MD Anderson Cancer Center — Orlando, Florida, United States
• Hematology Oncology Assoc. — Pensacola, Florida, United States
• Emory University Cancer Institute — Atlanta, Georgia, United States
• Medical College of Georgia — Augusta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Stroger Cook County Hospital — Chicago, Illinois, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• University of Chicago Hospital — Chicago, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• St. Francis Hospital & Health Centers — Beech Grove, Indiana, United States
• University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
• Cancer Center of Kansas — Wichita, Kansas, United States
• University of South Alabama Cancer Research Institute — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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