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 trial is active, not recruiting.
|Targets||HDAC, HIF-1a, VEGF|
|Start date||June 2013|
|End date||November 2018|
|Trial size||9 participants|
|Trial identifier||NCT01802879, 2012-005252-41, CLBH589B2402B|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Duarte, CA||City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(1)||no longer recruiting|
|Augusta, GA||Georgia Regents University SC-2||no longer recruiting|
|Boston, MA||Dana Farber Cancer Institute Reg. Ped||no longer recruiting|
|Salt Lake City, UT||University of Utah / Huntsman Cancer Institute SC-2||no longer recruiting|
|Jerusalem, Israel||Novartis Investigative Site||no longer recruiting|
|Leiden, Netherlands||Novartis Investigative Site||no longer recruiting|
|Salamanca, Spain||Novartis Investigative Site||no longer recruiting|
|Intervention model||single group assignment|
Number of patients receiving single agent panobinostat
time frame: 5 years
Number fo patients experiencing Serious Adverse Events (SAEs)
time frame: 5 years
All participants of any age.
- 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.
- 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
|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|
|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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