Overview

This trial is active, not recruiting.

Condition hematologic neoplasms
Treatment panobinostat
Phase phase 2
Targets HDAC, HIF-1a, VEGF
Sponsor Novartis Pharmaceuticals
Start date June 2013
End date October 2018
Trial size 9 participants
Trial identifier NCT01802879, 2012-005252-41, CLBH589B2402B

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
single agent panobinostat, starting with last assigned dose and regimen patient received in parent study
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 Outcomes

Measure
Number of patients receiving single agent panobinostat
time frame: 5 years

Secondary Outcomes

Measure
Number fo patients experiencing Serious Adverse Events (SAEs)
time frame: 5 years

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Novartis.