- Having participated in Novartis study CAMN107A2109, and
- Written signed and dated informed consent prior to any study procedures being performed.
- Impaired cardiac function,
- Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon) up to the day before study drug administration; Other concurrent severe and/or uncontrolled medical conditions,
- Patients who are currently receiving treatment with any of the medications that have the potential to prolong the QT interval,
- patients who have undergone a major surgery and have not recovered from side effects of such therapy within 15 days,
- Patients who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control, OR
- Patients unwilling or unable to comply with the protocol.
Other protocol -defined inclusion/exclusion criteria may apply
Expanded Access program information for companies listed in the Expanded Access Company Directory is pulled daily from ClinicalTrials.gov, a resource provided by the National Institutes of Health in cooperation with the U.S. Food and Drug Administration. Click here for more information about ClinicalTrials.gov.