CompletedNCT03017690Updated Dec 21, 2018

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

An observational study in Gastroenteropancreatic Neuroendocrine Tumor, sponsored by Ipsen. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-21.

Study summary

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.

Conditions studied

Gastroenteropancreatic Neuroendocrine Tumor

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In context

Neuroendocrine Tumors

676 studies on the registry are indexed under Neuroendocrine Tumors; 169 are open to participants now.

This study's enrollment of 22 is below the median of 115 across 176 observational studies indexed under Neuroendocrine Tumors.

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Lead sponsor

Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

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

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

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 design

Observational model: Cohort
Time perspective: Cross-sectional
Enrollment: 22 participants (actual)
Patient registry: No

Groups and cohorts

lanreotide group (Somatuline Depot®)
octreotide LAR group (Sandostatin LAR®)

What researchers measure

Primary outcomes

The total time for product preparation and administration
Total drug delivery time
Time frame: Day 1

Secondary outcomes

Total patient wait time for administration
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.
Time frame: Day 1
Number of clogging episodes
The number of clogging episodes for lanreotide and octreotide LAR will be recorded and compared.
Time frame: Day 1
Healthcare resource utilization
The materials used for the preparation of lanreotide and octreotide LAR will be recorded and compared.
Time frame: Day 1
Pharmacist and/or nurse satisfaction and product preference
Assessed by pharmacist and/or nurse completing questionnaire
Time frame: Day 1 and at the end of the study (approximately 3 months)
Patient satisfaction
Assessed by patient completing questionnaire
Time frame: Day 1

Study locations

5 sites

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

References and documents

Publications

Ryan P, McBride A, Ray D, Pulgar S, Ramirez RA, Elquza E, Favaro JP, Dranitsaris G. Lanreotide vs octreotide LAR for patients with advanced gastroenteropancreatic neuroendocrine tumors: An observational time and motion analysis. J Oncol Pharm Pract. 2019 Sep;25(6):1425-1433. doi: 10.1177/1078155219839458. Epub 2019 Mar 29. PubMed 30924737 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03017690
Lead sponsor: Ipsen
Responsible party: Sponsor
First posted: Jan 11, 2017
Start date: Apr 12, 2017
Primary completion: May 30, 2018
Completion: May 30, 2018
Last update: Dec 21, 2018

Study contacts

Ipsen Medical Director

study director · Ipsen

Oversight

Data monitoring committee: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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