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

This study is ongoing, but not recruiting participants.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00302016

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 III

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Imatinib Imatinib mesylate 4-Methyl-N-(3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-pyridin-3-ylpyrimidin-2-yl)amino)benzamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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.

Further study details as provided by Novartis:

Primary Outcome Measures:

Evaluate safety profile
Provide patients with expanded access

Secondary Outcome Measures:

No secondary outcomes/objectives planned

Estimated Enrollment:	2000
Study Start Date:	January 2006

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

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

Show 273 Study Locations

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Study ID Numbers:	CAMN107A2109
Study First Received:	March 9, 2006
Last Updated:	December 18, 2007
ClinicalTrials.gov Identifier:	NCT00302016
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Chronic myeloid leukemia
AMN 107
Imatinib resistant or intolerant
nilotinib
enact

Study placed in the following topic categories:

Imatinib
Blast Crisis
Leukemia
Chronic myelogenous leukemia
Hematologic Diseases

Myeloproliferative Disorders
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009