Trial Information

An Open-label Multi-center Single Agent Panobinostat Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Panobinostat Study and Are Judged by the Investigator to Benefit From Continued Single Agent Panobinostat Treatment

This is a multi-center open label study to provide continued use of single agent oral
panobinostat to patients currently treated in a Novartis-sponsored study (parent study)
which has met its endpoint and are benefiting from continuation of the treatment with
single-agent panobinostat as judged by the investigator. Patients from multiple parent
studies will be transferred over to this protocol and will be continuing to receive single
agent panobinostat at the last assigned dose and regimen of the parent protocol. There will
be no screening period, and patients will have to visit the study center at least on a
quarterly basis. During these visits limited information on study treatment and occurrence
of SAEs will be collected for the clinical database. SAEs will be only reported to the
Novartis safety database.Other assessments and possibly more frequent visits will occur as
per standard of care at the site. Patients will continue treatment until they are no longer
benefiting from panobinostat treatment develop unacceptable toxicities, withdraw consent,
are non-compliant to the protocol, the investigator feels it is no longer in the best
interest to continue, the patient dies, or for other administrative reasons. An end of
treatment visit and a safety follow-up for 30 days after the last dose will be performed.
The study is expected to remain open for 5 years or until such time that enrolled patients
no longer need treatment with panobinostat, whichever comes earlier.