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

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Disease Information

Descriptive Information
Brief Title † Pharmacokinetics, Efficacy and Safety of an Octreotide Implant in Patients With Carcinoid Syndrome
Official Title † Open Label Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Two Doses of an Octreotide Implant in Patients With Carcinoid Syndrome
Brief Summary Evaluate the pharmacokinetics, safety and efficacy of an octreotide implant for the treatment of the symptoms of carcinoid syndrome.
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.
Study Phase Phase 1/Phase 2
Study Type † Interventional
Study Design † Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † Assess the effects of 1 or 2 implants on carcinoid syndrome symptoms of flushing and diarrhea
Secondary Outcome Measure † safety and tolerability of the implants
Condition † Carcinoid Syndrome
Intervention † DrugOctreotide
Study Arms / Comparison Groups 1 implant 117 mg Octreotide implant 2 implants 234 mg Octreotide implant
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 10
Start Date † July 2009
Completion Date December 2011
Primary Completion Date November 2011
Eligibility Criteria † 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 Both
Ages 18 Years - 80 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT00884715
Organization ID IP107-002
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Endo Pharmaceuticals
Collaborators ††
Investigators † : ,
Information Provided By
Verification Date September 2013
First Received Date † April 20, 2009
Last Updated Date September 17, 2013
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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