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

Phase 1

Terminated

• Conditions: Carcinoid Syndrome
• Interventions: Drug: Octreotide

• Registration Number: NCT00884715
• Lead Sponsor: Endo Pharmaceuticals

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 Timeline

• Study First Submitted: 2009-04-20
• Study First Submitted QC: 2009-04-20
• Study First Posted: 2009-04-21
• Study Start: 2009-07
• Primary Completion: 2011-11
• Study Completion: 2011-12
• Status Verified: 2013-09
• Disposition First Submitted: 2013-09-09
• Disposition First Submitted QC: 2013-09-09
• Last Update Submitted: 2013-09-17
• Disposition First Posted: 2013-09-20
• Last Update Posted: 2013-09-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 implant	Octreotide	117 mg Octreotide implant
2 implants	Octreotide	234 mg Octreotide implant

Primary Outcome Measures

Name	Time	Method
Assess the effects of 1 or 2 implants on carcinoid syndrome symptoms of flushing and diarrhea	9 months

Secondary Outcome Measures

Name	Time	Method
safety and tolerability of the implants	9 months