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

NCT03017690 | Completed

• 1 other identifier: A-US-52030-358
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 5

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.

Conditions

Gastroenteropancreatic Neuroendocrine Tumor

Outcome Measures

Primary Outcomes (1)

• The total time for product preparation and administration

  Total drug delivery time

  Day 1

Secondary Outcomes (5)

• Total patient wait time for administration

  Day 1

• Number of clogging episodes

  Day 1

• Healthcare resource utilization

  Day 1

• Pharmacist and/or nurse satisfaction and product preference

  Day 1 and at the end of the study (approximately 3 months)

• Patient satisfaction

  Day 1

Study Arms (2)

lanreotide group (Somatuline Depot®)

octreotide LAR group (Sandostatin LAR®)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (5)

The University of Arizona Cancer Center

Tucson, Arizona, 85719, United States

Location

Ochsner Medical Center Kenner

Kenner, Louisiana, 70065, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

National Translational Research Group

East Setauket, New York, 11733, United States

Location

Oncology Specialists of Charlotte

Charlotte, North Carolina, 28207, United States

Location

Related Publications (1)

• 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.

  PMID: 30924737 DERIVED

MeSH Terms

Conditions

Gastro-enteropancreatic neuroendocrine tumor

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2016
• First Posted: January 11, 2017
• Study Start: April 12, 2017
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: December 21, 2018

Record last verified: 2018-12

Locations

US (5)