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

Novartis

Status

Conditions: Chronic Myeloid Leukemia

Treatments: Drug: AMN107

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT00302016

CAMN107A2109

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.