NCT03895463

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2019

Typical duration for all trials

Geographic Reach
1 country

11 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2023

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

3.7 years

First QC Date

March 27, 2019

Last Update Submit

November 4, 2020

Conditions

Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (1)

  • Progression-Free Survival (PFS)

    To estimate the rate according to investigator assessment (radiological progression; based on Response Evaluation Criteria In Solid Tumours version 1.0 \[RECIST 1.0\])

    12 months

Secondary Outcomes (8)

  • Median PFS

    24 months

  • Tumour origin

    24 months

  • Tumour grade

    24 months

  • Quality of Life (QoL)

    24 months

  • Disease Control Rate

    24 months

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult subjects with GEP-NETs eligible for treatment with Lanreotide Autogel 120 mg or currently being treated with Lanreotide Autogel 120 mg every 28 days for a period of up to 5 months. Subjects will receive treatment as prescribed by the physician and in accordance with the current Summary of Product Characteristics (SmPC).

You may qualify if:

  • 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.
  • Treatment with Lanreotide Autogel 120 mg alone, according to local Summary of Product Characteristics (SmPC).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Uniwersyteckie Centrum Kliniczne

Gdansk, 80952, Poland

Location

Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Oddział w Gliwicach

Gliwice, 44102, Poland

Location

Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibińskiego Śląskiego Uniwersytetu Medycznego w Katowicach

Katowice, 40514, Poland

Location

Świętokrzyskie Centrum Onkologii

Kielce, 25734, Poland

Location

Szpital Uniwersytecki w Krakowie

Krakow, 31501, Poland

Location

SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi

Lodz, 92213, Poland

Location

Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego w Poznaniu

Poznan, 60355, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego im. prof. Tadeusza Sokołowskiego

Szczecin, 71252, Poland

Location

Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie

Warsaw, 02034, Poland

Location

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego, Centralny Szpital Kliniczny

Warsaw, 02097, Poland

Location

Dolnośląskie Centrum Onkologii we Wrocławiu

Wroclaw, 53413, Poland

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2019

First Posted

March 29, 2019

Study Start

August 1, 2019

Primary Completion

March 26, 2023

Study Completion

March 26, 2023

Last Updated

November 5, 2020

Record last verified: 2020-11

Locations

PL(11)