Expanded Access Program of AMN107 in Imatinib-resistant or Intolerant Adult Patients With Chronic Myeloid Leukemia
An Open-label, Multicenter, Expanded Access Study of Oral AMN107 in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase, or Chronic Phase.
1 other identifier
expanded_access
N/A
33 countries
265
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 becomes commercially available.
Trial Health
Trial Health Score
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265 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 9, 2006
CompletedFirst Posted
Study publicly available on registry
March 13, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedAugust 26, 2011
August 1, 2011
2.8 years
March 9, 2006
August 25, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (270)
University of South Alabama Cancer Research Institute
Mobile, Alabama, 36693, United States
Arizona Cancer Center
Tucson, Arizona, 85724, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
Antelope Valley Cancer Center
Lancaster, California, 93534, United States
Stanford University
Palo Alto, California, 94304, United States
University of Colorado
Aurora, Colorado, 80010, United States
Rocky Mountain Cancer Center
Denver, Colorado, 80218, United States
Georgetown University Medical Center-Lombardi Cancer Center
Washington D.C., District of Columbia, 20007-2113, United States
Washington Cancer Institute
Washington D.C., District of Columbia, 20010, United States
Osler Medical Inc./Osler Clinical Research
Melbourne, Florida, 32901, United States
Advanced Medical Specialties
Miami, Florida, 33176, United States
Integrated Community
Orange Park, Florida, 32073, United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804, United States
MD Anderson Cancer Center
Orlando, Florida, 32806, United States
Hematology Oncology Assoc.
Pensacola, Florida, 32501, United States
Emory University Cancer Institute
Atlanta, Georgia, 30322, United States
Medical College of Georgia
Augusta, Georgia, 30912, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Stroger Cook County Hospital
Chicago, Illinois, 60612, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
University of Chicago Hospital
Chicago, Illinois, 60637, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
St. Francis Hospital & Health Centers
Beech Grove, Indiana, 46107, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
Louisville Oncology Research
Louisville, Kentucky, 40202, United States
LSU Health Sciences Center
Shreveport, Louisiana, 71103, United States
St. Agnes Hospital
Baltimore, Maryland, 21229, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Wayne State University
Detroit, Michigan, 48201, United States
St. John Hospital and Medical Center
Grosse Pointe, Michigan, 48236, United States
Mayo Clinic Hospital
Rochester, Minnesota, 55905, United States
Southeast Nebraska Cancer Center
Lincoln, Nebraska, 68516, United States
Nebraska Methodist Cancer Center
Omaha, Nebraska, 68114, United States
Nevada Cancer Institute
Las Vegas, Nevada, 89135, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131, United States
Cancer Institute of New Mexico
Santa Fe, New Mexico, 87505, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Winthrop Hematology/Oncology
Mineola, New York, 11501, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10017, United States
Weill Cornell Medical Center
New York, New York, 10021, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Duke University
Durham, North Carolina, 27710, United States
Wake Forest University
Winston-Salem, North Carolina, 27157, United States
Cancer Care Associates
Oklahoma City, Oklahoma, 734112, United States
Cancer Care Associates
Tulsa, Oklahoma, 74136, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, 15224, United States
Charleston Hematology Oncology
Charleston, South Carolina, 29403, United States
MUSC Hollings Cancer Center
Charleston, South Carolina, 29425, United States
Three Medical Park
Columbia, South Carolina, 29203, United States
Cancer Center of the Carolinas
Greenville, South Carolina, 29615, United States
The Jones Clinic
Germantown, Tennessee, 38138, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
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Samsun, Turkey (Türkiye)
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Related Publications (1)
Zhou L, Meng F, Yin O, Wang J, Wang Y, Wei Y, Hu P, Shen Z. Nilotinib for imatinib-resistant or -intolerant chronic myeloid leukemia in chronic phase, accelerated phase, or blast crisis: a single- and multiple-dose, open-label pharmacokinetic study in Chinese patients. Clin Ther. 2009 Jul;31(7):1568-75. doi: 10.1016/j.clinthera.2009.07.016.
PMID: 19695406DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2006
First Posted
March 13, 2006
Study Start
January 1, 2006
Primary Completion
November 1, 2008
Last Updated
August 26, 2011
Record last verified: 2011-08