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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


Phase 2
N/A
N/A
Not Enrolling
Both
Hematologic Neoplasms

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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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of patients receiving single agent panobinostat

Outcome Description:

To allow continued use of single agenet panobinostat to patients receiving oral panobinostat in Novartis-sponsored study (parent study) which has reached its objectives and who are benefiting from treatment with oral panobinostat.

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLBH589B2402B

NCT ID:

NCT01802879

Start Date:

April 2013

Completion Date:

July 2018

Related Keywords:

  • Hematologic Neoplasms
  • Hematologic Neoplasms, LBH589,
  • Panobinostat,
  • Neoplasms
  • Hematologic Neoplasms

Name

Location

City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(1)Duarte, California  91010-3000
Georgia Regents University SC-2Augusta, Georgia  30912
Dana Farber Cancer Institute SC-8Boston, Massachusetts  02115