Clinical Trial: Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in a Novartis-sponsored Study.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: An Open Label, Multi-center Pasireotide Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Pasireotide Study and Are Judged by the Investigator to Benefit From Continued

Brief Summary: The purpose of this study is to allow continued use of pasireotide in patients who are on pasireotide treatment in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study and are benefiting from the treatment as judged by the investigator.

Detailed Summary:

This is a multi-center, open label, phase IV study to provide continued supply of pasireotide to patients being treated in a current Novartis-sponsored, Oncology CD&MA study and who are benefiting from treatment with pasireotide. Eligible patients are to be consented and can then continue treatment with pasireotide in this protocol. All patients at their scheduled visits will have drug dispensing information and reported adverse events and serious adverse events collected.

A patient will reach the end of study when pasireotide treatment is permanently discontinued and the end of treatment visit has been performed. All patients must be followed up for safety evaluations for 3 months following the last dose of pasireotide LAR treatment and for 1 month following the last dose of pasireotide s.c. treatment.

The study is expected to remain open for approximately 10 years or until such time that enrolled patients no longer need treatment with pasireotide or are able to obtain commercial supply according to local regulations for their medical condition.


Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Number of patients receiving pasireotide [ Time Frame: Approximately 10 years ]

The study is expected to remain open for approximately 10 years or until such time that enrolled patients no longer need treatment with pasireotide or are able to obtain commercial supply according to local regulations for their medical condition. A patient will reach the end of study when pasireotide treatment is permanently discontinued.


Original Primary Outcome: Same as current

Current Secondary Outcome: Frequency and nature of serious adverse events (SAEs) [ Time Frame: as necessary up to 10 years ]

Collect long term safety data, i.e. SAEs and 'AEs of special interest'. SAES will be reviewed and reported as part of the regular pharmacovigilance activities.


Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: February 15, 2013
Date Started: December 2012
Date Completion: July 2024
Last Updated: December 30, 2016
Last Verified: December 2016