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

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00302016
First received: March 9, 2006
Last updated: August 25, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Chronic Myeloid Leukemia
Drug: AMN107
Phase 3

Study Type: Expanded Access     What is Expanded Access?
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Novartis:

Study Start Date: January 2006
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00302016

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Locations
United States, Alabama
University of South Alabama Cancer Research Institute
Mobile, Alabama, United States, 36693
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
Antelope Valley Cancer Center
Lancaster, California, United States, 93534
Stanford University
Palo Alto, California, United States, 94304
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80010
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
United States, District of Columbia
Georgetown University Medical Center-Lombardi Cancer Center
Washington, District of Columbia, United States, 20007-2113
Washington Cancer Institute
Washington, District of Columbia, United States, 20010
United States, Florida
Osler Medical Inc./Osler Clinical Research
Melbourne, Florida, United States, 32901
Advanced Medical Specialties
Miami, Florida, United States, 33176
Integrated Community
Orange Park, Florida, United States, 32073
MD Anderson Cancer Center
Orlando, Florida, United States, 32806
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
Hematology Oncology Assoc.
Pensacola, Florida, United States, 32501
United States, Georgia
Emory University Cancer Institute
Atlanta, Georgia, United States, 30322
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Illinois
University of Chicago Hospital
Chicago, Illinois, United States, 60637
Stroger Cook County Hospital
Chicago, Illinois, United States, 60612
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Loyola University Medical Center
Maywood, Illinois, United States, 60153
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St. Francis Hospital & Health Centers
Beech Grove, Indiana, United States, 46107
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University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
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Cancer Center of Kansas
Wichita, Kansas, United States, 67214
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Louisville Oncology Research
Louisville, Kentucky, United States, 40202
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LSU Health Sciences Center
Shreveport, Louisiana, United States, 71103
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St. Agnes Hospital
Baltimore, Maryland, United States, 21229
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University of Michigan
Ann Arbor, Michigan, United States, 48109
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Detroit, Michigan, United States, 48201
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Grosse Pointe, Michigan, United States, 48236
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Rochester, Minnesota, United States, 55905
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Lincoln, Nebraska, United States, 68516
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Omaha, Nebraska, United States, 68114
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Las Vegas, Nevada, United States, 89135
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Hackensack, New Jersey, United States, 07601
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Albuquerque, New Mexico, United States, 87131
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Santa Fe, New Mexico, United States, 87505
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Buffalo, New York, United States, 14263
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Mineola, New York, United States, 11501
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New York, New York, United States, 10021
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Rochester, New York, United States, 14642
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Durham, North Carolina, United States, 27710
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Winston Salem, North Carolina, United States, 27157
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Tulsa, Oklahoma, United States, 74136
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Portland, Oregon, United States, 97239
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Pittsburgh, Pennsylvania, United States, 15224
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Charleston, South Carolina, United States, 29425
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Columbia, South Carolina, United States, 29203
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Greenville, South Carolina, United States, 29615
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Germantown, Tennessee, United States, 38138
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Nashville, Tennessee, United States, 37232
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Dallas, Texas, United States, 75390
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Salt Lake City, Utah, United States, 84106
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Seattle, Washington, United States, 98104
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00302016     History of Changes
Obsolete Identifiers: NCT00532649
Other Study ID Numbers: CAMN107A2109
Study First Received: March 9, 2006
Last Updated: August 25, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Chronic myeloid leukemia
AMN 107
Imatinib resistant or intolerant
nilotinib
enact

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2014