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

Primary Purpose

Carcinoid Syndrome

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Octreotide
Sponsored by
Endo Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoid Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1 implant

2 implants

Arm Description

117 mg Octreotide implant

234 mg Octreotide implant

Outcomes

Primary Outcome Measures

Assess the effects of 1 or 2 implants on carcinoid syndrome symptoms of flushing and diarrhea

Secondary Outcome Measures

safety and tolerability of the implants

Full Information

First Posted
April 20, 2009
Last Updated
September 17, 2013
Sponsor
Endo Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00884715
Brief Title
Pharmacokinetics, Efficacy and Safety of an Octreotide Implant in Patients With Carcinoid Syndrome
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 Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Why Stopped
Program was terminated for business reasons
Study Start Date
July 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endo Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoid Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 implant
Arm Type
Experimental
Arm Description
117 mg Octreotide implant
Arm Title
2 implants
Arm Type
Experimental
Arm Description
234 mg Octreotide implant
Intervention Type
Drug
Intervention Name(s)
Octreotide
Intervention Description
short acting octreotide
Primary Outcome Measure Information:
Title
Assess the effects of 1 or 2 implants on carcinoid syndrome symptoms of flushing and diarrhea
Time Frame
9 months
Secondary Outcome Measure Information:
Title
safety and tolerability of the implants
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Iowa
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.endo.com/
Description
Click here for more information about this study

Learn more about this trial

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

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