Clinical trial NCT03017690: Lanreotide and Octreotide Long Acting Release (LAR) for Patients With Advanced Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)
Official title: Lanreotide and Octreotide LAR for Patients With Advanced Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs): An Observational Time and Motion Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroenteropancreatic Neuroendocrine Tumor
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2017-01-11
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited through US institutions/clinics that commonly treat neuroendocrine tumor patients.

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.


Eligibility criteria: 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

Primary outcomes:
measure: The total time for product preparation and administration
timeFrame: Day 1
Secondary outcomes:
measure: Total patient wait time for administration
timeFrame: Day 1
measure: Number of clogging episodes
timeFrame: Day 1
measure: Healthcare resource utilization
timeFrame: Day 1
measure: Pharmacist and/or nurse satisfaction and product preference
timeFrame: Day 1 and at the end of the study (approximately 3 months)
measure: Patient satisfaction
timeFrame: Day 1
Other outcomes:
Locations:
city: Tucson
country: United States
facility: The University of Arizona Cancer Center
state: Arizona
city: Kenner
country: United States
facility: Ochsner Medical Center Kenner
state: Louisiana
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: East Setauket
country: United States
facility: National Translational Research Group
state: New York
city: Charlotte
country: United States
facility: Oncology Specialists of Charlotte
state: North Carolina
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.