Efficacy and Safety of Lanreotide Autogel in Tumour Stabilization of Patients With Progressive Neuroendocrine Tumours

November 4, 2020 updated by: Ipsen

Phase II, Open, Single Group, Multicentre Study to Evaluate the Efficacy and Safety of Lanreotide Autogel Administered Every 4 Weeks by Deep Subcutaneous Injection in the Tumour's Growth Stabilization of Patients With Progressive Neuroendocrine Tumours Who Are Not Eligible to be Treated With Either Surgery or Chemotherapy

To evaluate, in patients with progressive neuroendocrine tumours who are not eligible to be treated with either surgery or chemotherapy at the moment of study inclusion, the efficacy of lanreotide Autogel in tumour growth stabilization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • A Coruña, Spain, 15006
        • H. Juan Canalejo
      • Alcoy, Spain, 03804
        • H. Virgen de los Lirios
      • Alicante, Spain, 03010
        • H. General Univ. de Alicante
      • Badalona, Spain, 08916
        • H. Germans Trias i Pujol
      • Barcelona, Spain, 08227
        • Consorci Sanitari de Terrassa
      • Barcelona, Spain, 08036
        • H. Clinic i Provincial
      • Barcelona, Spain, 08025
        • H. Santa Creu i Sant Pau
      • Barcelona, Spain, 08208
        • Corporación H. Parc Tauli
      • Barcelona, Spain, 08906
        • H. General de Hospitalet
      • Bilbao, Spain, 48013
        • H. de Basurto
      • Elche, Spain, 03203
        • H. General de Elche
      • Madrid, Spain, 28034
        • H. Ramon y Cajal
      • Madrid, Spain, 28006
        • H. de la Princesa
      • Madrid, Spain, 28040
        • H. Clínico Univ. San Carlos
      • Madrid, Spain, 28041
        • H. 12 de Octubre
      • Madrid, Spain, 28911
        • H. Severo Ochoa
      • Palma de Mallorca, Spain, 07198
        • Fundación H. Son Llàtzer
      • Pontevedra, Spain, 36001
        • Consorcio H. de Pontevedre
      • Sagunto, Spain, 46520
        • H. de Sagunto
      • Salamanca, Spain, 37007
        • H. Clínico de Salamanca
      • San Sebastián, Spain, 20012
        • Int. Oncológico San Sebastián
      • Santander, Spain, 39008
        • H. Marques De Valdecilla
      • Tenerife, Spain, 38320
        • H. Univ. de Canarias
      • Valencia, Spain, 446017
        • Hospital Universitario "Dr. Peset"
      • Valencia, Spain, 46009
        • H. la Fé
      • Valencia, Spain, 46014
        • H. Hospital General Universitario de Valencia
      • Zaragoza, Spain, 50009
        • H. Miguel Servet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with histopathologic diagnosis of well-differentiated neuroendocrine tumour or carcinoma according to WHO classification
  • patients who, according to RECIST criteria (Response Evaluation Criteria in Solid Tumours) present measurable disease
  • patients with progressive disease in the previous 6 months before their inclusion in the study
  • patients with positive IN111 octreotide scintigraphy

Exclusion Criteria:

  • patients with surgically removable localised disease
  • patients with progressive disease in the first six months of being diagnosed
  • patients with intestinal obstruction due to a carcinoid tumour
  • patients who have received treatment with somatostatin analogues during the 6 months before being included in the study
  • patients who have received treatment with radiotherapy, chemotherapy or interferon 4 weeks before being included in the study, or planned to receive these during the study
  • patients who have received treatment with liver artery embolisation or radiopharmaceuticals (endoradiotherapy) 12 weeks before being included in the study, or planned during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: lanreotide (Autogel formulation)
120mg administered via deep subcutaneous injection every 28 days for up to 24 months or until disease progression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to disease progression (appearance of 1+ new lesions or increase >or= to 20% of sum of the longest diameters of target lesions compared to the lower sum of maximum diameters recorded since the start of the study).
Time Frame: Month 3, 6, 9, 12, 15, 18, 21 and 24
Month 3, 6, 9, 12, 15, 18, 21 and 24

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate efficacy related to tumour's partial or total response, biological disease markers response, symptomatic control, effect of treatment on patient's quality of life
Time Frame: Month 3, 6, 9, 12, 15, 18, 21 and 24
Month 3, 6, 9, 12, 15, 18, 21 and 24
Identify tumour growth stabilization predictive factors under treatment with lanreotide Autogel
Time Frame: Month 3, 6, 9, 12, 18, 21 and 24
Month 3, 6, 9, 12, 18, 21 and 24
Tolerance
Time Frame: All visits
All visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

May 15, 2006

First Submitted That Met QC Criteria

May 15, 2006

First Posted (Estimate)

May 16, 2006

Study Record Updates

Last Update Posted (Actual)

November 5, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-92-52030-166
  • 2004-002871-18 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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