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 currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01802879
First received: February 26, 2013
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    To collect long term data on SAEs


Estimated Enrollment: 9
Study Start Date: June 2013
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01802879

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

Locations
United States, California
City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(1) Recruiting
Duarte, California, United States, 91010-3000
Contact: Jeanett Chen       jeanchen@coh.org   
Principal Investigator: Leslie Popplewell         
United States, Georgia
Georgia Regents University SC-2 Recruiting
Augusta, Georgia, United States, 30912
Contact: Carol Terry    706-721-4430    cterry@mcg.edu   
Principal Investigator: Jeremy Pantin         
United States, Massachusetts
Dana Farber Cancer Institute SC-8 Recruiting
Boston, Massachusetts, United States, 02115
Contact: Virginia Dalton    617-632-3655    Kathleen_Colson@dhci.harvard.edu   
Principal Investigator: Paul G. Richardson         
United States, Utah
University of Utah / Huntsman Cancer Institute SC-2 Not yet recruiting
Salt Lake City, Utah, United States, 84103
Contact: Rian Davis       Rian.davis@hci.utah.edu   
Principal Investigator: Sunil Sharma         
France
Novartis Investigative Site Withdrawn
Dijon, France, 21034
Israel
Novartis Investigative Site Active, not recruiting
Jerusalem, Israel, 91120
Spain
Novartis Investigative Site Active, not recruiting
Salamanca, Castilla y Leon, Spain, 37007
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01802879     History of Changes
Other Study ID Numbers: CLBH589B2402B, 2012-005252-41
Study First Received: February 26, 2013
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration
France: Ministry of Health
Israel: Ministry of Health
Spain: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
European Union: European Medicines Agency

Keywords provided by Novartis:
Hematologic Neoplasms, LBH589,
Panobinostat,

Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases
Panobinostat
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014