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

Overview

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

Full Title of Study: “Open Label Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Two Doses of an Octreotide Implant in Patients With Carcinoid Syndrome”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2011

Detailed Description

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.

Interventions

  • Drug: Octreotide
    • short acting octreotide

Arms, Groups and Cohorts

  • Experimental: 1 implant
    • 117 mg Octreotide implant
  • Experimental: 2 implants
    • 234 mg Octreotide implant

Clinical Trial Outcome Measures

Primary Measures

  • Assess the effects of 1 or 2 implants on carcinoid syndrome symptoms of flushing and diarrhea
    • Time Frame: 9 months

Secondary Measures

  • safety and tolerability of the implants
    • Time Frame: 9 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Endo Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor

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