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Trial record 7 of 1320 for:    Hematologic neoplasm

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01802879
Recruitment Status : Completed
First Posted : March 4, 2013
Last Update Posted : August 16, 2019
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment Phase
Hematologic Neoplasms Drug: Panobinostat Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : June 24, 2013
Actual Primary Completion Date : November 19, 2018
Actual Study Completion Date : November 19, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 :
  1. Number fo patients experiencing Serious Adverse Events (SAEs) [ Time Frame: 5 years ]
    To collect long term data on SAEs

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01802879

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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, 91120
Novartis Investigative Site
Leiden, Netherlands, 2300 RC
Novartis Investigative Site
Salamanca, Castilla Y Leon, Spain, 37007
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01802879     History of Changes
Other Study ID Numbers: CLBH589B2402B
2012-005252-41 ( EudraCT Number )
First Posted: March 4, 2013    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Hematologic Neoplasms, LBH589,
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action