NCT00884715

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2009

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 21, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

September 20, 2013

Status Verified

September 1, 2013

Enrollment Period

2.3 years

First QC Date

April 20, 2009

Last Update Submit

September 17, 2013

Conditions

Carcinoid Syndrome

Outcome Measures

Primary Outcomes (1)

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

    9 months

Secondary Outcomes (1)

  • safety and tolerability of the implants

    9 months

Study Arms (2)

1 implant

EXPERIMENTAL

117 mg Octreotide implant

Drug: Octreotide

2 implants

EXPERIMENTAL

234 mg Octreotide implant

Drug: Octreotide

Interventions

OctreotideDRUG

short acting octreotide

1 implant2 implants

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • poorly differentiated or high grade neuroendocrine tumor
  • significant cv, hepatic, renal or other disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Iowa City, Iowa, 52242, United States

Location

Unknown Facility

Boston, Massachusetts, 02115, United States

Location

Unknown Facility

Burlington, Massachusetts, 01805, United States

Location

Related Links

MeSH Terms

Conditions

Serotonin Syndrome

Interventions

Octreotide

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2009

First Posted

April 21, 2009

Study Start

July 1, 2009

Primary Completion

November 1, 2011

Study Completion

December 1, 2011

Last Updated

September 20, 2013

Record last verified: 2013-09

Locations

US(3)