CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 337 enrolled
Drug / intervention
Pasireotide +2 moredrug
Likely dose
Pasireotide 0.3mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01794793
NCT01794793Phase 4Completed
CompareCT.gov

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

RECORDATI GROUP·interventional·Posted Feb 20, 2013·Updated Oct 1, 2024

In Brief

A Phase 4 clinical trial evaluating Pasireotide, Cabergoline, and 1 other intervention for Cushing's Disease and 8 related conditions. Completed, enrolled 337 participants across 94 sites in 28 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCushing's Disease, Acromegaly, Neuroendocrine Tumors, Pituitary Tumors, Ectopic ACTH Secreting (EAS) Tumors, Dumping Syndrome, Prostate Cancer, Melanoma Negative for bRAF, Melanoma Negative for nRAS
CountriesArgentina, 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), United States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 20, 2013
Enrollment StartJun 10, 2013
Primary CompletionJul 25, 2023
TodayJul 2, 2026
Enrollment to primary: 10.1 yearsPosted 13.4 years ago

Interventions

Pasireotidedrug

Administered subcutaneously in strengths 0.3mg, 0.6mg and 0.9mg. Doses to be taken BID or TID, dependent on parent study guidelines.

Cabergolinedrug

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.

Pasireotide LARdrug

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.