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

Completed

• Conditions: Gastroenteropancreatic Neuroendocrine Tumor

• Registration Number: NCT03017690
• Lead Sponsor: Ipsen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-30
• Study First Submitted QC: 2017-01-09
• Study First Posted: 2017-01-11
• Study Start: 2017-04-12
• Primary Completion: 2018-05-30
• Study Completion: 2018-05-30
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The total time for product preparation and administration	Day 1	Total drug delivery time

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Oncology Specialists of Charlotte; 🇺🇸 Charlotte, North Carolina, United States

The University of Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

Ochsner Medical Center Kenner; 🇺🇸 Kenner, Louisiana, United States

Mercy Medical Center; 🇺🇸 Baltimore, Maryland, United States

National Translational Research Group; 🇺🇸 East Setauket, New York, United States