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

This study has been terminated.
(Program was terminated for business reasons)
Information provided by (Responsible Party):
Endo Pharmaceuticals Identifier:
First received: April 20, 2009
Last updated: September 17, 2013
Last verified: September 2013
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 Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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:

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 ]

Secondary Outcome Measures:
  • safety and tolerability of the implants [ Time Frame: 9 months ]

Enrollment: 10
Study Start Date: July 2009
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 implant
117 mg Octreotide implant
Drug: Octreotide
short acting octreotide
Experimental: 2 implants
234 mg Octreotide implant
Drug: Octreotide
short acting octreotide

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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00884715

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:
Responsible Party: Endo Pharmaceuticals Identifier: NCT00884715     History of Changes
Other Study ID Numbers: IP107-002
Study First Received: April 20, 2009
Last Updated: September 17, 2013

Additional relevant MeSH terms:
Malignant Carcinoid Syndrome
Serotonin Syndrome
Carcinoid Tumor
Pathologic Processes
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents processed this record on September 21, 2017