An Open-label, Multicenter, Phase II Study Evaluating the Safety and Efficacy of Twice Daily Dosing of SOM230 in Patients With Metastatic Carcinoid Tumors

Novartis Pharmaceuticals4 sites in 1 country45 target enrollmentJanuary 2004

ConditionsCarcinoid Tumors

InterventionsPasireotide (SOM230)

DrugsPasireotide (SOM230)

Overview

Phase: Phase 2
Intervention: Pasireotide (SOM230)
Conditions: Carcinoid Tumors
Sponsor: Novartis Pharmaceuticals
Enrollment: 45
Locations: 4
Primary Endpoint: Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Study evaluating SOM230 in patients with metastatic carcinoid tumors

Registry

clinicaltrials.gov

Start Date

January 2004

End Date

July 2008

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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
•Patients who had received radiotherapy for any reason within the last 4 weeks must have recovered from any side effects of radiotherapy
•Patients who have congestive heart failure unstable angina, cardiac arrhythmia or a history of acute myocardial infarction within the three months preceding enrollment
•Patients with chronic liver disease
•Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method for birth control.
•History of immunocompromise, including a positive HIV test result
•Patients who have a history of alcohol or drug abuse in the 6 month period prior to receiving SOM230

Arms & Interventions

Pasireotide

Intervention: Pasireotide (SOM230)

Outcomes

Primary Outcomes

Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary

Time Frame: 15 days

Complete Symptom Control: an average of ≤ 3 bowel movements per day for at least 15 consecutive days, with no more than 3 episodes on any given day, and no episodes of flushing over the time interval being studied. Partial Symptom Control: an average of \< 4 bowel movements per day for at least 15 consecutive days, with no more than 6 episodes per given day, and an average of fewer than 2 daily flushing episodes over the same given time interval. Treatment failure: Failure to obtain partial or complete treatment success over a consecutive 15-day period at a constant dose level.

Secondary Outcomes

Duration of Complete Symptom Control (Days) by Dose Class(15 days)
Duration of Partial Symptom Control (Days) by Dose Class(up to 15 days)
The Number of Patients (Participants) With Overall Tumor Response(At least 15 days)
The Overall Safety and Tolerability of Pasireotide(At least 15 days)