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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00302016 |
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 |
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Chronic Myeloid Leukemia |
Drug: AMN107 |
Phase III |
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. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply
Study Chair: | Novartis | Novartis |
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 |
Chronic myeloid leukemia AMN 107 Imatinib resistant or intolerant nilotinib enact |
Imatinib Blast Crisis Leukemia Chronic myelogenous leukemia Hematologic Diseases |
Myeloproliferative Disorders Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Bone Marrow Diseases |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |