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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