Overview

This trial is active, not recruiting.

Condition carcinoid syndrome
Treatments somatuline depot (lanreotide), placebo
Phase phase 3
Sponsor Ipsen
Start date March 2009
End date May 2013
Trial size 115 participants
Trial identifier NCT00774930, 2-55-52030-730, 2010-019066-92, TR321

Summary

The purpose of this study is to determine whether monthly injections of Somatuline Depot are effective and safe in controlling diarrhea and flushing in patients with carcinoid syndrome. In countries where Somatuline Depot is not approved, patients well controlled at the end of the open-label phase will be able to participate in a long-term open-label extension phase.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
somatuline depot (lanreotide) Somatuline Autogel
subcutaneous injection, 120 mg, q28d
(Placebo Comparator)
placebo
inactive substance

Primary Outcomes

Measure
Usage of subcutaneous octreotide to control symptoms associated with carcinoid syndrome, measured as the % of days that subcutaneous octreotide is used as rescue medication based on patient Interactive Voice Response System ( IVRS) diary records
time frame: 16 week double-blind phase of the study

Secondary Outcomes

Measure
Frequency of diarrhea events (per day) based on patient IVRS diary records.
time frame: 16-week double-blind phase
Frequency of flushing events (per day) based on patient IVRS diary records.
time frame: 16-week double-blind phase
Usage of other rescue medications for diarrhea and/or flushing events, measured as the percentage of days that the medications were used as rescue medication based on patient IVRS diary records.
time frame: 16-week double-blind phase
Proportion of patients who roll over into the open-label phase before completing the double-blind phase of the study.
time frame: Week 16
Changes from baseline in Quality of Life (QoL); assessed using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30-Carcinoid/NETs module: EORTC QLQ-G.I. NET 21
time frame: 16-week double-blind phase
Absolute changes from baseline in biochemical marker - plasma Chromogranin A (CgA).
time frame: 16-week double-blind phase
Absolute changes from baseline in biochemical marker - urinary 5-hydroxyindoleacetic acid (5-HIAA).
time frame: 16-week double-blind phase

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - histopathologically confirmed diagnosis of carcinoid tumor or a carcinoid tumor of unknown location with liver metastases - history of carcinoid syndrome (flushing and/or diarrhea) - either naive to treatment with a Somatostatin analog or responsive to conventional doses of LAR or subcutaneous octreotide - confirmation of positive somatostatin receptor status by somatostatin receptor scintigraphy - absence of tumor progression Exclusion Criteria: - history of carcinoid syndrome refractory to treatment with conventional doses of Somatostatin analogs - treatment with interferon, chemotherapy and/or radiotherapy, a radiolabelled Somatostatin analog and/or tumor debulking < 3 months prior to study entry - history of hepatic arterial embolization - short bowel syndrome - uncontrolled diabetes and/or hypertension - severe renal impairment and/or liver impairment - diagnosis of cardiac disease

Additional Information

Official title A Double-blind, Randomized Placebo-controlled Clinical Trial Investigating the Efficacy and Safety of Somatuline Depot (Lanreotide) Injection in the Treatment of Carcinoid Syndrome
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Ipsen.