Study to Assess the Use of Lanreotide Autogel® 120 mg in Patients With Locally Advanced or Metastatic Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) in Routine Clinical Practice

Overview

The main aim of this study is to assess the Progression-Free Survival (PFS) at 12 months of Lanreotide Autogel 120 mg use when administered as part of routine GEP-NET treatment and to follow patient treatment pathways, identify prognostic factors of PFS, evaluate patient's QoL, and patient's and clinician's satisfaction with treatment in routine long-term care setting. The study will provide real-world evidence on the use of Lanreotide Autogel 120 mg and will provide information on topics such as optimization of product usage and identification of best practices and will provide evidence on product effectiveness in a realistic setting.

Full Title of Study: “Prospective Noninterventional Study to Assess the Use of Lanreotide Autogel® 120 mg in Patients With Locally Advanced or Metastatic Gastroenteropancreatic Tumours (GEP-NETs) in Routine Clinical Practice”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 26, 2023

Clinical Trial Outcome Measures

Primary Measures

  • Progression-Free Survival (PFS)
    • Time Frame: 12 months
    • To estimate the rate according to investigator assessment (radiological progression; based on Response Evaluation Criteria In Solid Tumours version 1.0 [RECIST 1.0])

Secondary Measures

  • Median PFS
    • Time Frame: 24 months
  • Tumour origin
    • Time Frame: 24 months
  • Tumour grade
    • Time Frame: 24 months
  • Quality of Life (QoL)
    • Time Frame: 24 months
    • To describe the change in Quality of Life (QoL) as assessed by European Organisation for Research and Treatment of Cancer (EORTC) QoL questionnaire for gastrointestinal neuroendocrine tumours (QLQ-GINET21 questionnaires). Where the patient assess experienced symptoms or problems using the scale from 1 to 4. Where 1 represents “not at all” and 4 “very much”.
  • Disease Control Rate
    • Time Frame: 24 months
    • To estimate the Disease Control Rate (DCR), as assessed by investigator (proportion of subjects with a best overall response of Partial Response [PR], Complete Response [CR] or Stable Disease [SD]).
  • Chromogranin A (CgA) level
    • Time Frame: 24 months
  • Patients’ satisfaction
    • Time Frame: 24 months
    • To evaluate patients’ satisfaction using abbreviated 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9). It assesses key dimensions of treatment satisfaction: Effectiveness, Convenience and Global Satisfaction. The effectiveness scored as: 1 (extremely dissatisfied) to 7 (extremely satisfied). For the convenience scored as 1 (extremely difficult) to 7 (extremely easy).
  • Urine 5-hydroxyindoleaceticacid (5-HIAA) levels
    • Time Frame: 24 months

Participating in This Clinical Trial

Inclusion Criteria

  • Functioning or non-functioning histopathologically confirmed, locally advanced or metastatic (grade 1 or grade 2 according to the World Health Organisation (WHO) 2017 classification and European Neuroendocrine Tumour Society (ENETS) grading system) GEP-NET G1,G2 (Ki67≤10%, based on recent Ki67). – Measurable disease, as defined by RECIST 1.0, on a CT scan/MRI obtained up to 6 weeks prior to initiation of treatment with Lanreotide Autogel 120 mg. – Subject eligible for treatment with Lanreotide Autogel 120 mg or subject currently being treated with Lanreotide Autogel 120 mg administered every 28 days for a period no longer than 5 months prior to inclusion – Treatment with Lanreotide Autogel 120 mg alone, according to local Summary of Product Characteristics (SmPC). Exclusion Criteria:

  • Lanreotide Autogel treatment for more than 5 months prior to inclusion into the study – Concomitant anti-proliferative medication/therapies for GEP NET at initiation of Lanreotide Autogel treatment (e.g. Peptide Receptor Radionuclide Therapy (PRRT), cytotoxic chemotherapy, targeted therapy everolimus, sunitinib, interferon, loperamide). – Has been treated with PRRT, chemotherapy, everolimus, sunitinib or interferon within 3 months prior to initiation of Lanreotide Autogel treatment – Parallel participation in an interventional study

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ipsen
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ipsen Medical Director, Study Director, Ipsen

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