Lanreotide and Octreotide Long Acting Release (LAR) for Patients With Advanced Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- 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).
- 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