Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies

Prostate Cancer Clinical Trial

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 Pasireotide Treatment

Status Completed

Clinical Trial Summary

The purpose of this study is to allow continued use of pasireotide in patients who are on pasireotide treatment in a Novartis-sponsored study and are benefiting from the treatment as judged by the investigator.

Clinical Trial Description

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 study and who are benefiting from treatment with pasireotide alone or in combination with another treatment for Cushing's Disease and Acromegaly . Eligible patients are to be consented and can then continue treatment with pasireotide alone or in combination with another treatment for Cushing's Disease and Acromegaly 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. ;

Related Conditions & MeSH terms

• Acromegaly
• ACTH-Secreting Pituitary Adenoma
• Cushing's Disease
• Dumping Syndrome
• Ectopic ACTH Secreting (EAS) Tumors
• Melanoma
• Melanoma Negative for bRAF
• Melanoma Negative for nRAS
• Neuroendocrine Tumors
• Pituitary ACTH Hypersecretion
• Pituitary Diseases
• Pituitary Neoplasms
• Pituitary Tumors
• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT01794793
• Study type: Interventional
• Source: RECORDATI GROUP
• Status: Completed
• Phase: Phase 4
• Start date: June 10, 2013
• Completion date: July 29, 2023