Pharmacokinetics, Efficacy and Safety of an Octreotide Implant in Patients With Carcinoid Syndrome

Phase 2TerminatedNCT00884715

Endo Pharmaceuticals10 enrolled

Overview

Evaluate the pharmacokinetics, safety and efficacy of an octreotide implant for the treatment of the symptoms of carcinoid syndrome.

This study will evaluate a longer acting octreotide formulation. A subcutaneous implant at 2 doses will be evaluated for pharmacodynamics, efficacy and safety for a period of 9 months.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoid Syndrome

Interventions

OctreotideDRUG

short acting octreotide

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * histologically confirmed tumor * documented evidence of carcinoid syndrome * life expectancy of at least 6 months * previous positive octreotide scan * received stable doses of octreotide injections * performance status of 0-2 on the ECOG performance scale Exclusion Criteria: * poorly differentiated or high grade neuroendocrine tumor * significant cv, hepatic, renal or other disease

Locations (3)

Unnamed facility

Iowa City, Iowa, United States

Unnamed facility

Boston, Massachusetts, United States

Unnamed facility

Burlington, Massachusetts, United States

Outcomes

Primary Outcomes

Assess the effects of 1 or 2 implants on carcinoid syndrome symptoms of flushing and diarrhea

Time frame: 9 months

Secondary Outcomes

safety and tolerability of the implants

Time frame: 9 months

Data from ClinicalTrials.gov

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