Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03017690
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Ipsen

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Gastroenteropancreatic Neuroendocrine Tumor

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Lanreotide and Octreotide LAR for Patients With Advanced Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs): An Observational Time and Motion Analysis
Actual Study Start Date : April 12, 2017
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
lanreotide group (Somatuline Depot®)
octreotide LAR group (Sandostatin LAR®)


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The total time for product preparation and administration [ Time Frame: Day 1 ]
    Total drug delivery time


Secondary Outcome Measures :
  1. Total patient wait time for administration [ Time Frame: 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.

  2. Number of clogging episodes [ Time Frame: Day 1 ]
    The number of clogging episodes for lanreotide and octreotide LAR will be recorded and compared.

  3. Healthcare resource utilization [ Time Frame: Day 1 ]
    The materials used for the preparation of lanreotide and octreotide LAR will be recorded and compared.

  4. Pharmacist and/or nurse satisfaction and product preference [ Time Frame: Day 1 and at the end of the study (approximately 3 months) ]
    Assessed by pharmacist and/or nurse completing questionnaire

  5. Patient satisfaction [ Time Frame: Day 1 ]
    Assessed by patient completing questionnaire


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited through US institutions/clinics that commonly treat neuroendocrine tumor patients.
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017690


Locations
Layout table for location information
United States, Arizona
The University of Arizona Cancer Center
Tucson, Arizona, United States, 85719
United States, Louisiana
Ochsner Medical Center Kenner
Kenner, Louisiana, United States, 70065
United States, Maryland
Mercy Medical Center
Baltimore, Maryland, United States, 21202
United States, New York
National Translational Research Group
East Setauket, New York, United States, 11733
United States, North Carolina
Oncology Specialists of Charlotte
Charlotte, North Carolina, United States, 28207
Sponsors and Collaborators
Ipsen
Investigators
Layout table for investigator information
Study Director: Ipsen Medical Director Ipsen
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT03017690    
Other Study ID Numbers: A-US-52030-358
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018

Layout table for additional information
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroendocrine Tumors
Intestinal Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Stomach Diseases