Switching From Octreotide to Lanreotide - A Look Back at Patients With Neuroendocrine Tumors

NCT03112694 | Completed

• 1 other identifier: A-US-52030-364
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to understand how people with neuroendocrine tumors respond to treatment with lanreotide after having received treatment with octreotide.

Conditions

Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (1)

• Response to treatment

  Evaluated as responsive disease (i.e., complete response, partial response), stable disease or progressive disease at the last tumor assessment while on treatment with lanreotide (based on tumor imaging, symptoms, biomarker(s) and/or clinical judgement)

  4 months (data collection duration)

Secondary Outcomes (8)

• Progression-free survival, after treatment with octreotide

  4 months (data collection duration)

• Duration of response to lanreotide, after treatment with octreotide

  4 months (data collection duration)

• Duration of treatment with octreotide and duration of treatment with lanreotide

  4 months (data collection duration)

• Severity of Adverse Events

  4 months (data collection duration)

• Reasons for switching from octreotide to lanreotide

  4 months (data collection duration)

Interventions

Data collection OTHER

This is a non-interventional study, the decision to prescribe the product would have been taken prior to, and independently from the decision to enrol the patient.

Eligibility Criteria

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

Study Population

Hospitals and clinics

You may qualify if:

• Males and females age 18 years or older at time of locally advanced or metastatic diagnosis
• Patients with a confirmed diagnosis of locally advanced or metastatic Gastroenteropancreatic neuroendocrine tumour (GEP-NET)
• Patients who switched treatment from long acting octreotide LAR to lanreotide, where both treatments were received for the treatment of locally advanced or metastatic GEP-NET. i. Treatment with long acting octreotide LAR monotherapy for at least 90-days before treatment with lanreotide monotherapy (rescue SSA# use permitted). ii. Treatment with lanreotide monotherapy for at least 90-days after treatment with long acting octreotide monotherapy (rescue SSA# use permitted)

You may not qualify if:

• Patients with other malignant disease
• Patients who participated in a concomitant clinical trial related to treatment of GEP-NET
• Patients being treated with a Somatostatin analogue (SSA) in combination with other NET treatments excluding rescue SSA#
• Patients who received other primary treatment (e.g., targeted therapy, chemotherapy) for GEP-NET during the interval between octreotide and lanreotide
• Patients with NET familial genetic syndrome (i.e., MEN1)

Sponsors & Collaborators

• Ipsen: lead

Study Sites (8)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Cancer Center of Kansas

Wichita, Kansas, 67214, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

National Transitional Research

East Setauket, New York, 11733, United States

Location

Allegheny Cancer Center

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 13, 2017
• Study Start: April 4, 2017
• Primary Completion: November 2, 2017
• Study Completion: November 2, 2017
• Last Updated: June 2, 2020

Record last verified: 2020-06

Locations

US (8)