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

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ClinicalTrials.gov Identifier: NCT00884715
Recruitment Status : Terminated (Program was terminated for business reasons)
First Posted : April 21, 2009
Last Update Posted : September 20, 2013
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Carcinoid Syndrome Drug: Octreotide Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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
Study Start Date : July 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : December 2011


Arm Intervention/treatment
Experimental: 1 implant
117 mg Octreotide implant
Drug: Octreotide
short acting octreotide

Experimental: 2 implants
234 mg Octreotide implant
Drug: Octreotide
short acting octreotide




Primary Outcome Measures :
  1. Assess the effects of 1 or 2 implants on carcinoid syndrome symptoms of flushing and diarrhea [ Time Frame: 9 months ]

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


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00884715     History of Changes
Other Study ID Numbers: IP107-002
First Posted: April 21, 2009    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Syndrome
Carcinoid Tumor
Malignant Carcinoid Syndrome
Serotonin Syndrome
Disease
Pathologic Processes
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Octreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents