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

Neuroendocrine Tumors Clinical Trial

Official title:

A Multicenter, Retrospective, Medical Record Review Of The Effectiveness Of Lanreotide Following Treatment With Octreotide In Patients With Neuroendocrine Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03112694
• Other study ID #: A-US-52030-364
• Status: Completed
• Start date: April 4, 2017
• Est. completion date: November 2, 2017

Study information

• Verified date: June 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: November 2, 2017
• Est. primary completion date: November 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Intervention

Other:
• Data collection
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.

Locations

Country	Name	City	State
United States	Mercy Medical Center	Baltimore	Maryland
United States	Tufts Medical Center	Boston	Massachusetts
United States	National Transitional Research	East Setauket	New York
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Allegheny Cancer Center	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Moffitt Cancer Center	Tampa	Florida
United States	Cancer Center of Kansas	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression-free survival, after treatment with octreotide	For evaluating progression-free survival events will include radiographic progression per investigator, biomarker progression per investigator, symptom progression per investigator, and death. Adverse events (AEs) will not be considered as an event.	4 months (data collection duration)
Secondary	Duration of response to lanreotide, after treatment with octreotide	For evaluating duration of response events will include radiographic progression per investigator, biomarker progression per investigator, symptom progression per investigator, AEs, and death. Open ended responses will be reviewed during the analysis and determined to be an eligible "event" or not at that time.	4 months (data collection duration)
Secondary	Duration of treatment with octreotide and duration of treatment with lanreotide	Duration of octreotide treatment assessed as time from start of octreotide treatment to stop of octreotide treatment. Duration of lanreotide treatment assessed as time from lanreotide initiation to end of lanreotide treatment (censored at the date of last administration (+lanreotide frequency) for patients who had ongoing lanreotide treatment).	4 months (data collection duration)
Secondary	Severity of Adverse Events	Summarized separately during treatment with octreotide and during treatment with lanreotide, as available	4 months (data collection duration)
Secondary	Reasons for switching from octreotide to lanreotide	Summarized descriptively	4 months (data collection duration)
Secondary	Levels of 5-hydroxyindoleacetic acid (5-HIAA) (urine test or blood test) before treatment with octreotide, during treatment with octreotide and during treatment with lanreotide, as available	Summarized descriptively	4 months (data collection duration)
Secondary	Levels of Chromogranin A (CgA) before treatment with octreotide, during treatment with octreotide and during treatment with lanreotide, as available	Summarized descriptively	4 months (data collection duration)
Secondary	Severity of symptoms (i.e., flushing, diarrhea, dyspnea, abdominal pain, edema, nausea) before treatment with octreotide, during treatment with octreotide, and during treatment with lanreotide, as available	Proportion of patients reporting each symptom	4 months (data collection duration)