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

  • STATUS
    Not Recruiting
  • End date
    Jun 9, 2023
  • participants needed
    500
  • sponsor
    Novartis Pharmaceuticals
Updated on 26 January 2021
combination therapy
cabergoline
pasireotide
cushing's syndrome
cushing

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.

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.

Details
Condition Malignant neoplasm of prostate, Cushing's disease, Neuroendocrine Tumor, Neuroectodermal Tumor, Pituitary Disease, Acromegaly, Prostatic disorder, Pituitary Adenoma, Dumping Syndrome, Prostate Disorders, Prostate Cancer, Early, Recurrent, Ectopic ACTH Secreting (EAS) Tumors, Melanoma Negative for bRAF, Melanoma Negative for nRAS, Neurectoderma, Ectopic ACTH Secreting (EAS) Tumors, Ectopic ACTH Secreting (EAS) Tumors, Ectopic ACTH Secreting (EAS) Tumors, Ectopic ACTH Secreting (EAS) Tumors, Ectopic ACTH Secreting (EAS) Tumors, Ectopic ACTH Secreting (EAS) Tumors, Ectopic ACTH Secreting (EAS) Tumors, Prostate Cancer, Pituitary Disorders, Ectopic ACTH Secreting (EAS) Tumors, Ectopic ACTH Secreting (EAS) Tumors, Ectopic ACTH Secreting (EAS) Tumors, Ectopic ACTH Secreting (EAS) Tumors, Ectopic ACTH Secreting (EAS) Tumors, Ectopic ACTH Secreting (EAS) Tumors, Ectopic ACTH Secreting (EAS) Tumors, Ectopic ACTH Secreting (EAS) Tumors, Ectopic ACTH Secreting (EAS) Tumors, Ectopic ACTH Secreting (EAS) Tumors
Treatment Pasireotide, Cabergoline
Clinical Study IdentifierNCT01794793
SponsorNovartis Pharmaceuticals
Last Modified on26 January 2021

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