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

NCT ID: NCT03017690

Last Updated: 2018-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-12

Study Completion Date

2018-05-30

Brief Summary

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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

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Conditions

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Gastroenteropancreatic Neuroendocrine Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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lanreotide group (Somatuline DepotĀ®)

No interventions assigned to this group

octreotide LAR group (Sandostatin LARĀ®)

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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The University of Arizona Cancer Center

Tucson, Arizona, United States

Site Status

Ochsner Medical Center Kenner

Kenner, Louisiana, United States

Site Status

Mercy Medical Center

Baltimore, Maryland, United States

Site Status

National Translational Research Group

East Setauket, New York, United States

Site Status

Oncology Specialists of Charlotte

Charlotte, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30924737 (View on PubMed)

Other Identifiers

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A-US-52030-358

Identifier Type: -

Identifier Source: org_study_id