Know Cancer

forgot password

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.

Phase 3
18 Years
Not Enrolling
Chronic Myeloid Leukemia

Thank you

Trial Information

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.

Inclusion 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.

Type of Study:

Expanded Access

Study Design:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

January 2006

Completion Date:

Related Keywords:

  • Chronic Myeloid Leukemia
  • Chronic myeloid leukemia
  • AMN 107
  • Imatinib resistant or intolerant
  • nilotinib
  • enact
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive



Wake Forest University Winston-Salem, North Carolina  27103
Arizona Cancer Center Tucson, Arizona  85724
University of Michigan Ann Arbor, Michigan  48109-0624
Memorial Sloan Kettering Cancer Center New York, New York  10021
Roswell Park Cancer Institute Buffalo, New York  14263
Loyola University Medical Center Maywood, Illinois  60153
Stanford University Stanford, California  94305
Swedish Cancer Institute Seattle, Washington  98104
Rush University Medical Center Chicago, Illinois  60612-3824
University of Rochester Medical Center Rochester, New York  14642
Hackensack University Medical Center Hackensack, New Jersey  07601
Florida Hospital Cancer Institute Orlando, Florida  32804
St. John Hospital and Medical Center Detroit, Michigan  48236
University of Illinois at Chicago Chicago, Illinois  60612
Mount Sinai Medical Center New York, New York  10029
Rocky Mountain Cancer Center Denver, Colorado  80218
City of Hope National Medical Center Los Angeles, California  91010
University of South Alabama Cancer Research Institute Mobile, Alabama  36604
University of Colorado Denver, Colorado  80217
Western Pennsylvania Cancer Institute Pittsburgh, Pennsylvania  15224
Vanderbilt University Medical Center Nashville, Tennessee  37232-2516
Washington Cancer Institute Washington, District of Columbia  20010
Medical College of Georgia Augusta, Georgia  30912
Duke University Durham, North Carolina  27710
Cancer Care Associates Tulsa, Oklahoma  74136
Oregon Health Sciences University Portland, Oregon  
Wayne State University Detroit, Michigan  48202
Weill Cornell Medical Center New York, New York  10021
Charleston Hematology Oncology Charleston, South Carolina  29403
Utah Cancer Specialists Salt Lake City, Utah  84106
LSU Health Sciences Center Shreveport, Louisiana  71130-3932
Cancer Center of the Carolinas Greenville, South Carolina  29615
The Jones Clinic Germantown, Tennessee  38138
Nevada Cancer Institute Las Vegas, Nevada  89135
Ut Southwestern Medical Center Dallas, Texas  75390
Cancer Center of Kansas Wichita, Kansas  67214
Southeast Nebraska Cancer Center Lincoln, Nebraska  68510
Antelope Valley Cancer Center Lancaster, California  93534
University of Chicago Hospital Chicago, Illinois  60637-1470
St. Agnes Hospital Baltimore, Maryland  21229
MUSC Hollings Cancer Center Charleston, South Carolina  29425
Advanced Medical Specialties Miami, Florida  33176
Cancer Institute of New Mexico Santa Fe, New Mexico  87505
Georgetown University Medical Center-Lombardi Cancer Center Washington, District of Columbia  20007-2113
Osler Medical Inc./Osler Clinical Research Melbourne, Florida  32901
Integrated Community Orange Park, Florida  32073
MD Anderson Cancer Center Orlando, Florida  32806
Hematology Oncology Assoc. Pensacola, Florida  32501
Emory University Cancer Institute Atlanta, Georgia  30322
Stroger Cook County Hospital Chicago, Illinois  60612
St. Francis Hospital & Health Centers Beech Grove, Indiana  46107
University of Iowa Hospitals & Clinics Iowa City, Iowa  52242
Louisville Oncology Research Louisville, Kentucky  40202
Mayo Clinic Hospital Rochester, Minnesota  55905
Nebraska Methodist Cancer Center Omaha, Nebraska  68114
University of New Mexico Health Sciences Center Albuquerque, New Mexico  87131
Winthrop Hematology/Oncology Mineola, New York  11501
Three Medical Park Columbia, South Carolina  29203