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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)
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00884715
First received: April 20, 2009
Last updated: August 16, 2012
Last verified: August 2012
History of Changes
  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 1
Phase 2

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
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
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 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: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00884715     History of Changes
Other Study ID Numbers: IP107-002
Study First Received: April 20, 2009
Last Updated: August 16, 2012
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 May 22, 2013