Study to Allow Access to Single Agent Panobinostat for Patients Who Are on s.a. Panobinostat Treatment in a Novartis-sponsored Study and Continue to Benefit From the Treatment as Judged by the Investigator

Hematologic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01802879
• Other study ID #: CLBH589B2402B
• Secondary ID: 2012-005252-41
• Status: Completed
• Phase: Phase 2
• Start date: June 24, 2013
• Est. completion date: November 19, 2018

Study information

• Verified date: November 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study allowed continued use of single agent panobinostat in patients who were on single agent panobinostat treatment in a Novartis-sponsored study which had met its endpoint and were benefiting from the treatment as judged by the investigator.

Description:

This was a multi-center open label study to provide continued use of single agent oral panobinostat to patients treated in a Novartis-sponsored study (parent study) which had met its endpoint and were benefiting from continuation of the treatment with single-agent panobinostat as judged by the investigator. Patients from multiple parent studies were transferred over to this protocol and continued to receive single agent panobinostat at the last assigned dose and regimen of the parent protocol. There was no screening period, and patients had to visit the study center at least on a quarterly basis. During these visits limited information on study treatment and occurrence of SAEs was collected for the clinical database. SAEs were only reported to the Novartis safety database. Other assessments and possibly more frequent visits occurred as per standard of care at the site. Patients continued treatment until they were no longer benefiting from panobinostat treatment, developed unacceptable toxicities, withdrew consent, were non-compliant with the protocol, the investigator believed it was no longer in the best interest to continue, the patient died, or for other administrative reasons. An end of treatment visit and a safety follow-up for 30 days after the last dose was performed. The study was expected to remain open for 5 years or until such time that enrolled patients no longer needed treatment with panobinostat, whichever came earlier.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: November 19, 2018
• Est. primary completion date: November 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patient had been enrolled in a Novartis-sponsored, Oncology OGD&GMA study receiving s.a. oral panobinostat and had fulfilled all their requirements in the parent study

• patient had been benefiting from the treatment with s.a. oral panobinostat as determined by the guidelines of the parent protocol and according to the Investigator's clinical judgment

• patient had demonstated compliance

• patient had given written informed consent.

Exclusion Criteria:

• patient had been permanently discontinued from s.a. oral panobinostat study treatment in the parent study due to unacceptable toxicity, withdrawal of consent, non-compliance to study procedures or any other reason (including progression of disease).

• patient had participated in a Novartis sponsored combincation trial where panobinostat was dispensed in combination with another study medication and was still receiving combination therapy

• patient was pregnant or nursing at the time of entry

• women of child-bearing potential and male patients with sexual partners of child-bearing potential who were unwilling to use highly effective methods of contraception during dosing and for a specified duration after stopping study treatment

Related Conditions & MeSH terms

• Hematologic Neoplasms

Intervention

Drug:
• Panobinostat
Panobinostat was provided as 5, 10 and 20 mg hard gelatin capsules to be taken orally. Patients started on dose from parent protocol and dose modifications were at the discretion of the investigator based on guidance provided in the protocol and IB.

Locations

Country	Name	City	State
Israel	Novartis Investigative Site	Jerusalem
Netherlands	Novartis Investigative Site	Leiden
Spain	Novartis Investigative Site	Salamanca	Castilla Y Leon
United States	Georgia Regents University SC-2	Augusta	Georgia
United States	Dana Farber Cancer Institute Reg. Ped	Boston	Massachusetts
United States	City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(1)	Duarte	California
United States	University of Utah / Huntsman Cancer Institute SC-2	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Israel,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overview of Adverse Events (Safety Set)	Adverse events were collected from baseline up to 30 days post treatment at scheduled visits. Severity of adverse events was assessed according to the current version of Common Terminology Criteria for Adverse Events (CTCAE). If CTCAE grading did not exist for an adverse event, the severity of mild, moderate, severe, and life-threatening, corresponding to Grades 1 - 4, was used	Baseline up to approximately 60 months
Secondary	Percentage of Patients With Clinical Benefit as Assessed by the Investigator.	Patients were assessed by investigators at scheduled visits to determine if patient continued to benefit from panobinostat therapy.	baseline up to approximate 5 years