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

This study is not yet open for participant recruitment.

Verified by Endo Pharmaceuticals Solutions Inc., April 2009

First Received: April 20, 2009 No Changes Posted

Sponsored by:	Endo Pharmaceuticals Solutions Inc.
Information provided by:	Endo Pharmaceuticals Solutions Inc.
ClinicalTrials.gov Identifier:	NCT00884715

Purpose

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

Condition	Intervention	Phase
Carcinoid Syndrome	Drug: octreotide acetate Drug: octreotide implant	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Pharmacokinetics Study
Official Title:	Open Label, Randomized Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Two Doses of an Octreotide Implant in Patients With Carcinoid Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Carcinoid Tumors

Drug Information available for: Octreotide acetate Octreotide

U.S. FDA Resources

Further study details as provided by Endo Pharmaceuticals Solutions Inc.:

Primary Outcome Measures:

Assess the effects of 1 or 2 implants on carcinoid syndrome symptoms of flushing and diarrhea [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

safety and tolerability of the implants [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	June 2009
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 implant: Experimental 117 mg implant	Drug: octreotide acetate one or two 117 mg octreotide implants Drug: octreotide implant 117 mg 234 mg
2 implants: Experimental 234 mg	Drug: octreotide acetate one or two 117 mg octreotide implants Drug: octreotide implant 117 mg 234 mg

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 6 months.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 on 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884715

Contacts

Contact: Mark Roessel

roessel.mark@endo.com

Locations

United States, Massachusetts

Burlington, Massachusetts, United States, 01805

Sponsors and Collaborators

Endo Pharmaceuticals Solutions Inc.

More Information

Additional Information:

Click here for more information about this study This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Lahey Clinic ( Keith Stuart )
Study ID Numbers:	IP107-002
Study First Received:	April 20, 2009
Last Updated:	April 20, 2009
ClinicalTrials.gov Identifier:	NCT00884715 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Carcinoid Syndrome
Antineoplastic Agents, Hormonal
Serotonin Syndrome
Poisoning
Octreotide
Disorders of Environmental Origin
Malignant Carcinoid Syndrome
Neuroendocrine Tumors

Carcinoma
Neuroectodermal Tumors
Drug Toxicity
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Carcinoid Tumor
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Disease
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Neoplasms, Nerve Tissue
Gastrointestinal Agents
Poisoning
Serotonin Syndrome
Octreotide
Disorders of Environmental Origin
Malignant Carcinoid Syndrome
Pharmacologic Actions

Neuroendocrine Tumors
Carcinoma
Neuroectodermal Tumors
Neoplasms
Pathologic Processes
Drug Toxicity
Therapeutic Uses
Syndrome
Neoplasms, Germ Cell and Embryonal
Carcinoid Tumor
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on August 24, 2009