Study to Allow Access to Single Agent Panobinostat for Patients Who Are on s.a. Panobinostat Treatment in a Novartis-sponsored Study and Are Benefiting From the Treatment as Judged by the Investigator



Status:Active, not recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:2/1/2019
Start Date:June 24, 2013
End Date:February 28, 2019

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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

The study allows continued use of single agent panobinostat in patients who are on single
agent panobinostat treatment in a Novartis-sponsored study which has met its endpoint and are
benefiting from the treatment as judged by the investigator.

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.

Inclusion Criteria:

- patient is currently enrolled in Novartis sponsored study, which has met its endpoint
and is receiving single agent oral panobinostat

- patient is currently benefiting from treatment with single agent oral panobinostat as
determined by the guidelines of the parent protocol and according to the
investigator's clinical judgment.

- patient has demonstated compliance

- patient has given written informed consent.

Exclusion Criteria:

- patient has been permanently discontinued from single agent oral panobinostat study
treatment in the parent study

- patient has participated in a Novartis sponsored combincation trial where panobinostat
was dispensed in combination with another study medication and is still receiving
combination therapy

- patient is pregnant or nursing at the time of entry

- women of child-bearing potential and male patients with sexual partners of
child-bearing potential unwilling to use highly effective methods of contraception
during dosing and for a specified duration after stopping study treatment

Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
5
sites
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from
Salt Lake City, UT
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Augusta, Georgia 30912
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from
Augusta, GA
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Boston, Massachusetts 02215
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mi
from
Boston, MA
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mi
from
Duarte, CA
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Jerusalem, 91120
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from
Jerusalem,
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