Pharmacokinetics, Efficacy and Safety of an Octreotide Implant in Patients With Carcinoid Syndrome - Full Text View

Sponsor:	Endo Pharmaceuticals
Information provided by:	Endo Pharmaceuticals
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:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Open Label 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:

Primary Outcome Measures:

Assess the effects of 1 or 2 implants on carcinoid syndrome symptoms of flushing and diarrhea [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

safety and tolerability of the implants [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	July 2009
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 implant 117 mg implant	Drug: octreotide acetate one or two 117 mg octreotide implants Drug: octreotide implant 117 mg 234 mg
Experimental: 2 implants 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 9 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 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

Contacts and Locations

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

Locations

United States, Iowa

Iowa, Iowa, United States, 52242
United States, Massachusetts

Boston, Massachusetts, United States, 02115

Burlington, Massachusetts, United States, 01805

Sponsors and Collaborators

Endo Pharmaceuticals

More Information

Additional Information:

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

No publications provided

Responsible Party:	Senior Director Clinical R&D, Endo Pharmaceuticals Solutions Inc
ClinicalTrials.gov Identifier:	NCT00884715 History of Changes
Other Study ID Numbers:	IP107-002
Study First Received:	April 20, 2009
Last Updated:	July 22, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Carcinoid Tumor
Malignant Carcinoid Syndrome
Serotonin Syndrome
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue
Drug Toxicity
Poisoning
Substance-Related Disorders
Octreotide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 09, 2012