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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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: February 26, 2013
Last updated: February 7, 2017
Last verified: February 2017
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.

Condition Intervention Phase
Hematologic Neoplasms
Drug: Panobinostat
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number of patients receiving single agent panobinostat [ Time Frame: 5 years ]
    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.

Secondary Outcome Measures:
  • Number fo patients experiencing Serious Adverse Events (SAEs) [ Time Frame: 5 years ]
    To collect long term data on SAEs

Enrollment: 9
Actual Study Start Date: June 24, 2013
Estimated Study Completion Date: November 9, 2018
Estimated Primary Completion Date: November 9, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Panobinostat
single agent panobinostat, starting with last assigned dose and regimen patient received in parent study
Drug: Panobinostat
single agent panobinostat starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications are at the discretion of the investigator based on guidance provided in the protocol and IB.

Detailed Description:
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.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT01802879

United States, California
City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(1)
Duarte, California, United States, 91010-3000
United States, Georgia
Georgia Regents University SC-2
Augusta, Georgia, United States, 30912
United States, Massachusetts
Dana Farber Cancer Institute Reg. Ped
Boston, Massachusetts, United States, 02215
United States, Utah
University of Utah / Huntsman Cancer Institute SC-2
Salt Lake City, Utah, United States, 84103
Novartis Investigative Site
Jerusalem, Israel, 9112001
Novartis Investigative Site
Leiden, Netherlands, 2300 RC
Novartis Investigative Site
Salamanca, Castilla y Leon, Spain, 37007
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01802879     History of Changes
Other Study ID Numbers: CLBH589B2402B
2012-005252-41 ( EudraCT Number )
Study First Received: February 26, 2013
Last Updated: February 7, 2017

Keywords provided by Novartis:
Hematologic Neoplasms, LBH589,

Additional relevant MeSH terms:
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 24, 2017