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

Gastroenteropancreatic Neuroendocrine Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03017690
• Other study ID #: A-US-52030-358
• Status: Completed
• Start date: April 12, 2017
• Est. completion date: May 30, 2018

Study information

• Verified date: December 2018
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastroenteropancreatic Neuroendocrine Tumor
• Intestinal Neoplasms
• Neuroendocrine Tumors
• Pancreatic Neoplasms
• Stomach Neoplasms

Locations

Country	Name	City	State
United States	Mercy Medical Center	Baltimore	Maryland
United States	Oncology Specialists of Charlotte	Charlotte	North Carolina
United States	National Translational Research Group	East Setauket	New York
United States	Ochsner Medical Center Kenner	Kenner	Louisiana
United States	The University of Arizona Cancer Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

United States, 

Outcome

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