NCT01794793

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

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 337 (actual)
• Sponsor: RECORDATI GROUP · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Pasireotide	Administered subcutaneously in strengths 0.3mg, 0.6mg and 0.9mg. Doses to be taken BID or TID, dependent on parent study guidelines.
DRUG	Cabergoline	Cabergoline tablet 0.5mg or 1.0mg taken by mouth once daily may be combined with subcutaneous formulation of pasireotide for Cushing's Disease or Acromegaly. Dose is dependent on parent study guidelines.
DRUG	Pasireotide LAR	Long Acting Release is administered by a single intramuscular (i.m.) monthly injection. The strengths are 10mg, 20mg, 40mg and 60mg. All doses to be taken q28days. Strength is dependent on parent study guidelines.

Timeline

• Start date: 2013-06-10
• Primary completion: 2023-07-25
• Completion: 2023-07-25
• First posted: 2013-02-20
• Last updated: 2024-10-01
• Results posted: 2024-08-28

Locations

94 sites across 28 countries: United States, Argentina, Belgium, Brazil, Bulgaria, Canada, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Peru, Poland, Portugal, Romania, Russia, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study