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 Pasireotide Treatment
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.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of patients receiving pasireotide
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.
Approximately 10 years
Yes
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CSOM230B2412
NCT01794793
May 2013
April 2023
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