Completed
An Open-label, Multicenter, Phase II Study Evaluating the Safety and Efficacy of Twice Daily Dosing of SOM230 in Patients With Metastatic Carcinoid Tumors
What is being tested
Pasireotide (SOM230)
Drug
Who is being recruted
Adenocarcinoma+10
+ Carcinoid Tumor
+ Carcinoma
From 18 to 80 Years
+16 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: January 2004
Summary
Principal SponsorNovartis Pharmaceuticals
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2004
Actual date on which the first participant was enrolled.Study evaluating SOM230 in patients with metastatic carcinoid tumors
Official TitleAn Open-label, Multicenter, Phase II Study Evaluating the Safety and Efficacy of Twice Daily Dosing of SOM230 in Patients With Metastatic Carcinoid Tumors
Principal SponsorNovartis Pharmaceuticals
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
45 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
AdenocarcinomaCarcinoid TumorCarcinomaNeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroectodermal TumorsNeuroendocrine TumorsSerotonin SyndromeChemically-Induced DisordersDrug-Related Side Effects and Adverse Reactions
Criteria
3 inclusion criteria required to participate
Patients with biopsy-proven metastatic carcinoid tumors
Patients with at least one measurable lesion (excluding bone)
Patients must be considered inadequately controlled while on Sandostatin LAR therapy based on the symptoms of carcinoid syndrome (diarrhea and/or flushing) as defined as experiencing a minimum average of at least four bowel movements per day or a minimum average of at least two episodes of flushing per day
13 exclusion criteria prevent from participating
Patients who have been previously treated with certain medications may be required to be without certain medications prior to entering the study
Patients who have undergone major recent surgery / surgical therapy for any cause within 1 month
Patients on any cytotoxic chemotherapy or interferon therapy within the last 2 months
Patients with uncontrolled diabetes mellitus
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 4 locations
Suspended
Cedars-Sinai Medical Center
Los Angeles, United StatesOpen Cedars-Sinai Medical Center in Google MapsSuspended
H. Lee Moffitt Cancer Center and Research Institute
Tampa, United StatesSuspended
Univ. Of Iowa Holden Cancer Center
Iowa City, United StatesSuspended
Louisiana State University Medical Center
New Orleans, United StatesCompleted4 Study Centers