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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03112694
Other study ID # A-US-52030-364
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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)
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