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

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

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00884715

Enrollment

Registered

2009-04-21

Start date

2009-07-31

Completion date

2011-12-31

Last updated

2013-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

DRUGOctreotide

short acting octreotide

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
safety and tolerability of the implants	9 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026