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

NCT ID: NCT00884715

Last Updated: 2013-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Carcinoid Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1 implant

117 mg Octreotide implant

Group Type EXPERIMENTAL

Octreotide

Intervention Type DRUG

short acting octreotide

2 implants

234 mg Octreotide implant

Group Type EXPERIMENTAL

Octreotide

Intervention Type DRUG

short acting octreotide

Interventions

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Octreotide

short acting octreotide

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Endo Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Iowa City, Iowa, United States

Site Status

Boston, Massachusetts, United States

Site Status

Burlington, Massachusetts, United States

Site Status

Countries

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United States

Related Links

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http://www.endo.com/

Click here for more information about this study

Other Identifiers

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IP107-002

Identifier Type: -

Identifier Source: org_study_id