Gastroenteropancreatic Neuroendocrine TumorNCT03017690
Lanreotide and Octreotide Long Acting Release (LAR) for Patients With Advanced Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)
An observational study of Gastroenteropancreatic Neuroendocrine Tumor, run by Ipsen at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroenteropancreatic Neuroendocrine Tumor
- How many people
- 22 participants
- Where
- 5 sitesUnited States
- Study dates
- 12 Apr 2017to 30 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited through US institutions/clinics that commonly treat neuroendocrine tumor patients.
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Mercy Medical Center
Baltimore, Maryland, 21202
Oncology Specialists of Charlotte
Charlotte, North Carolina, 28207
National Translational Research Group
East Setauket, New York, 11733
Ochsner Medical Center Kenner
Kenner, Louisiana, 70065
The University of Arizona Cancer Center
Tucson, Arizona, 85719
About this study
Official title: Lanreotide and Octreotide LAR for Patients With Advanced Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs): An Observational Time and Motion Analysis
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.
- Medical subject headings
- Gastro-enteropancreatic neuroendocrine tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| lanreotide group (Somatuline Depot®) | Not described | |
| octreotide LAR group (Sandostatin LAR®) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total time for product preparation and administration
Total drug delivery time
Measured: Day 1
Secondary outcomes (5)
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.
Measured: Day 1
Number of clogging episodes
The number of clogging episodes for lanreotide and octreotide LAR will be recorded and compared.
Measured: Day 1
Healthcare resource utilization
The materials used for the preparation of lanreotide and octreotide LAR will be recorded and compared.
Measured: Day 1
Pharmacist and/or nurse satisfaction and product preference
Assessed by pharmacist and/or nurse completing questionnaire
Measured: Day 1 and at the end of the study (approximately 3 months)
Patient satisfaction
Assessed by patient completing questionnaire
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study start12 Apr 2017
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroenteropancreatic Neuroendocrine TumorStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017690
- Sponsor's protocol ID
- A-US-52030-358
- Status last verified
- Dec 2018
- First submitted
- 30 Dec 2016
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30924737
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lanreotide and Octreotide LAR for Patients With Advanced Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs): An Observational Time and Motion Analysis
- ClinicalTrials.gov ID
- NCT03017690
- Acronym / sponsor ID
- A-US-52030-358
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 11 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lanreotide group (Somatuline Depot®) | – | – |
| octreotide LAR group (Sandostatin LAR®) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited through US institutions/clinics that commonly treat neuroendocrine tumor patients.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The total time for product preparation and administration
Time frame: Day 1
Total drug delivery time
5 secondary outcomes
Total patient wait time for administration
Time frame: Day 1
Number of clogging episodes
Time frame: Day 1
Healthcare resource utilization
Time frame: Day 1
Pharmacist and/or nurse satisfaction and product preference
Time frame: Day 1 and at the end of the study (approximately 3 months)
Patient satisfaction
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
- Derived from this study: PubMed 30924737Ryan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroenteropancreatic Neuroendocrine Tumor, run by Ipsen at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total time for product preparation and administration (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03017690, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2018; AzTrials last refreshed its copy on 6 Nov 2026.