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Trial record 9 of 35 for:    Lanreotide | Neuroendocrine Tumors

Efficacy and Safety Study in Pancreatic or Midgut Neuroendocrine Tumours Having Progressed Radiologically While Previously Treated With Lanreotide Autogel® 120 mg (CLARINET FORTE)

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ClinicalTrials.gov Identifier: NCT02651987
Recruitment Status : Active, not recruiting
First Posted : January 11, 2016
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Brief Summary:
This study aims to explore the efficacy and safety of lanreotide Autogel® 120 mg administered every 14 days in subjects with grade 1 or 2, metastatic or locally advanced, unresectable pancreatic or intestinal neuroendocrine tumours (NETs) once they have progressed on the standard dose of lanreotide Autogel® 120 mg every 28 days.

Condition or disease Intervention/treatment Phase
Pancreatic Tumours Midgut Neuroendocrine Tumours Drug: Lanreotide autogel 120 mg Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Lanreotide Autogel® 120 mg Administered Every 14 Days in Well Differentiated, Metastatic or Locally Advanced, Unresectable Pancreatic or Midgut Neuroendocrine Tumours Having Progressed Radiologically While Previously Treated With Lanreotide Autogel® 120 mg Administered Every 28 Days
Study Start Date : November 2015
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019


Arm Intervention/treatment
Experimental: Lanreotide Autogel®
One subcutaneous (SC) injection of lanreotide Autogel® 120mg every 14 days until disease progression or death or unacceptable toxicity or tolerability.
Drug: Lanreotide autogel 120 mg



Primary Outcome Measures :
  1. Median Progression Free Survival (PFS) Time [ Time Frame: Every 14 days up to approximately 102 weeks ]
    PFS is defined as time from first injection of lanreotide Autogel® 120 mg every 14 days to progression or death based on Response Evaluation Criteria in Solid Tumours (RECIST) v1.0


Secondary Outcome Measures :
  1. Median Time to Progression [ Time Frame: Every 14 days up to approximately 102 weeks ]
    Time to Progression is defined as time from first injection of lanreotide Autogel® 120 mg every 14 days to progression

  2. Proportion of subjects alive and without progression [ Time Frame: Every 12 weeks up to approximately 102 weeks ]
    Proportion of subjects alive and without progression every 12 weeks

  3. Overall survival [ Time Frame: Week 48 and at end of the study (up to approximately 102 weeks) ]
    Overall survival defined as the time from first study treatment to death due to any cause

  4. Overall Response Rate (ORR) [ Time Frame: Every 12 weeks up to approximately 102 weeks ]
    ORR every 12 weeks as per RECIST v1.0. is defined as the proportion of subjects who achieve either Complete response (CR) or Partial response (PR).

  5. Disease control rate (DCR) [ Time Frame: Weeks 24, 48 and at end of the study (up to approximately 102 weeks) ]
    The DCR is defined as the rate of CR plus PR plus Stable Disease (SD). DCR evaluated according to RECIST v1.0

  6. Best overall response [ Time Frame: At end of the study (up to approximately 102 weeks) ]
    Best overall response according to RECIST v1.0 defined as the best response recorded from the initiation of treatment until disease progression

  7. Median duration of Stable Disease (SD) [ Time Frame: Every 14 days up to approximately 102 weeks ]
    Median duration of SD according to RECIST v1.0 defined as the time from first injection of lanreotide Autogel® 120 mg every 14 days until the first occurrence of progressive disease by central assessment

  8. Total number of stools and flushing episodes [ Time Frame: During 1 week prior to visit until end of the study (up to approximately 102 weeks) ]
    Symptom control (diarrhoea, flushing) as measured by the total number of stools and flushing episodes during the 7 days prior to the visit reported orally by the subject to the investigator.

  9. Change in Quality of life (QLQ-C30) from baseline [ Time Frame: Every 12 weeks up to approximately 102 weeks ]
    Change in Quality of life from baseline every 12 weeks measured using European Organisation into the Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire Core 30 (QLQ-C30) v3.0.

  10. Change in Quality of life (QLQ-GI.NET21) from baseline [ Time Frame: Every 12 weeks up to approximately 102 weeks ]
    Change in Quality of life from baseline every 12 weeks measured using Quality of Life Questionnaire Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21; 2006)

  11. Change in Quality of life (EQ-5D-5L) from baseline [ Time Frame: Every 12 weeks up to approximately 102 weeks ]
    Change in Quality of life from baseline every 12 weeks measured using EuroQoL 5 dimensions, 5 levels (EQ-5D-5L) v1.0 questionnaire.

  12. Change in tumour biomarker concentrations from baseline [ Time Frame: Baseline, Weeks 2 and 12 and every 12 weeks thereafter, up to approximately 102 weeks ]
    Concentrations of non-specific (Chromogranin A, neuron specific enolase and 5-hydroxyindoleacetic acid) and specific tumour peptide biomarkers (e.g. pancreatic polypeptide, gastrin, glucagon, and somatostatin)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histopathologically confirmed, grade 1 or 2, metastatic or locally advanced, unresectable pNET (pNET cohort) or midgut NET (midgut cohort) with or without hormone related syndromes, with a proliferation index (Ki67) ≤20%.
  • Positive somatostatin receptors type 2
  • Progression as assessed by an independent central reviewer according to RECIST v1.0 while receiving first line treatment with lanreotide Autogel® at a standard dose of 120 mg every 28 days for at least 24 weeks

Exclusion Criteria:

  • Grade 3 or rapidly progressive (within 12 weeks) NET
  • Any NET other than pancreatic and midgut
  • Previous treatment with any antitumour agent for NET other than lanreotide Autogel® 120 mg every 28 days. Exception made of prior treatment with Octreotide at standard dose stopped for other reason than disease progression.
  • Symptomatic gallbladder lithiasis at screening echography or history of cholelithiasis with no cholecystectomy since then.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02651987


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Locations
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Belgium
Erasme Hospital
Bruxelles, Belgium, 1070
Cliniques Unversitaires Saint Luc
Bruxelles, Belgium, 1200
Antwerp University Hospital
Edegem, Belgium, 2650
UZ Leuven
Leuven, Belgium, B-3000
Denmark
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet
København, Denmark, 2100
France
Hôpital Beaujon
Clichy, France, 92118
Hôpital Edouard Herriot
Lyon, France, 69437
Institut Paoli Calmette
Marseille, France, 13273
Institut Gustave Roussy
Villejuif, France, 94805
Germany
Charité - CVK
Berlin, Germany, 13353
Universitätsklinikum Erlangen
Erlangen, Germany, 91054
Nationales Centrum für Tumorerkrankungen (NCT)
Heidelberg, Germany, 69120
Ireland
St Vincent's University Hospital
Dublin, Ireland, D4
Italy
IRCCS Azienda Ospedaliera Universitaria
San Martino, Genova, Italy, 16132
Azienda Ospedaliera - Universitaria Careggi
Firenze, Italy, 50134
Fondacione IRCCS Istituto Nazionale Dei Tumori
Milano, Italy, 20133
Università degli Studi "Federico II" di Napoli
Napoli, Italy, 80131
Azienda Ospedaliera sant'Andrea
Roma, Italy, 00189
Netherlands
AVL/NKI Medisch Oncologie
Amsterdam, Netherlands, 1066
Academic Medical Center
Amsterdam, Netherlands, 1105
Erasmus MC
Rotterdam, Netherlands, 3015
Poland
Samodzielny Publiczny Szpital Kliniczny nr 5
Katowice, Poland, 40-952
Katedra i Klinika Endokrynologii
Poznan, Poland, 60-355
Centrum Diagnostyczno-Lecznicze "GAMMED"
Warsaw, Poland, 02-348
Spain
Hospital Universitario Vall D'hebron
Barcelona, Spain, 08034
Hospital Universitario Ramón Y Cajal
Madrid, Spain, 28034
Hospital Universitario 12 De Octubre
Madrid, Spain, 28041
Hospital Universitario Central de Asturias
Oviedo, Spain, 33011
United Kingdom
Queen Elizabeth Medical Center
Birmingham, United Kingdom, B15 2TH
Royal Free Hospital
London, United Kingdom, NW3 2QG
The Christie Hospital NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen

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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02651987     History of Changes
Other Study ID Numbers: 8-79-52030-326
2014-005607-24 ( EudraCT Number )
First Posted: January 11, 2016    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Pancreatic Neoplasms
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Lanreotide
Angiopeptin
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Somatostatin
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs