Clinical Trial: 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
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
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 F
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.
Detailed Summary: 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.
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: Number of patients receiving single agent panobinostat [ Time Frame: 5 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Number fo patients experiencing Serious Adverse Events (SAEs) [ Time Frame: 5 years ]
Original Secondary Outcome: Same as current
Information By: Novartis
Dates:
Date Received: February 26, 2013
Date Started: June 24, 2013
Date Completion: November 9, 2018
Last Updated: February 7, 2017
Last Verified: February 2017