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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
First received: March 9, 2006
Last updated: August 25, 2011
Last verified: August 2011
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)

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

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

  Show 272 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

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

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

ClinicalTrials.gov processed this record on April 27, 2016