Lanreotide and Octreotide Long Acting Release (LAR) for Patients With Advanced Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

December 20, 2018 updated by: Ipsen

Lanreotide and Octreotide LAR for Patients With Advanced Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs): An Observational Time and Motion Analysis

An observational time and motion study in a clinical oncology setting is utilized in order to measure and compare product attributes and overall product efficiency between lanreotide and octreotide LAR.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • The University of Arizona Cancer Center
    • Louisiana
      • Kenner, Louisiana, United States, 70065
        • Ochsner Medical Center Kenner
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Mercy Medical Center
    • New York
      • East Setauket, New York, United States, 11733
        • National Translational Research Group
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Oncology Specialists of Charlotte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects will be recruited through US institutions/clinics that commonly treat neuroendocrine tumor patients.

Description

Inclusion Criteria:

  • Men and women must be 18 years of age or older
  • A current diagnosis of advanced, unresectable GEP-NET
  • Provided written informed consent to participate in the study
  • Currently receiving lanreotide or octreotide LAR and has received at least one prior injection of current somatostatin analogues (SSA).

Exclusion Criteria:

  • Receiving treatment with lanreotide or octreotide LAR as part of a clinical trial
  • Scheduled to receive a dose of lanreotide or octreotide LAR that would necessitate more than 1 injection on the same day
  • Scheduled to receive any other treatment in the infusion center/room on the same day and as part of the same appointment
  • Known hypersensitivity to somatostatin analogues

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
lanreotide group (Somatuline Depot®)
octreotide LAR group (Sandostatin LAR®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The total time for product preparation and administration
Time Frame: Day 1
Total drug delivery time
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total patient wait time for administration
Time Frame: Day 1
For the purposes of this study, "total patient wait time" refers to the time the patient checks in at the infusion room until completion of drug administration and discharge of the patient from the infusion room.
Day 1
Number of clogging episodes
Time Frame: Day 1
The number of clogging episodes for lanreotide and octreotide LAR will be recorded and compared.
Day 1
Healthcare resource utilization
Time Frame: Day 1
The materials used for the preparation of lanreotide and octreotide LAR will be recorded and compared.
Day 1
Pharmacist and/or nurse satisfaction and product preference
Time Frame: Day 1 and at the end of the study (approximately 3 months)
Assessed by pharmacist and/or nurse completing questionnaire
Day 1 and at the end of the study (approximately 3 months)
Patient satisfaction
Time Frame: Day 1
Assessed by patient completing questionnaire
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2017

Primary Completion (Actual)

May 30, 2018

Study Completion (Actual)

May 30, 2018

Study Registration Dates

First Submitted

December 30, 2016

First Submitted That Met QC Criteria

January 9, 2017

First Posted (Estimate)

January 11, 2017

Study Record Updates

Last Update Posted (Actual)

December 21, 2018

Last Update Submitted That Met QC Criteria

December 20, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-US-52030-358

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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