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

Primary Purpose

Pancreatic Tumours, Midgut Neuroendocrine Tumours

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lanreotide autogel 120 mg
Sponsored by
Ipsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Tumours

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Erasme Hospital
  • Cliniques Unversitaires Saint Luc
  • Antwerp University Hospital
  • UZ Leuven
  • Aarhus University Hospital
  • Rigshospitalet
  • Hôpital Beaujon
  • Hôpital Edouard Herriot
  • Institut Paoli Calmette
  • Institut Gustave Roussy
  • Charité - CVK
  • Universitätsklinikum Erlangen
  • Nationales Centrum für Tumorerkrankungen (NCT)
  • St Vincent's University Hospital
  • IRCCS Azienda Ospedaliera Universitaria
  • Azienda Ospedaliera - Universitaria Careggi
  • Fondacione IRCCS Istituto Nazionale Dei Tumori
  • Università degli Studi "Federico II" di Napoli
  • Azienda Ospedaliera sant'Andrea
  • AVL/NKI Medisch Oncologie
  • Academic Medical Center
  • Erasmus MC
  • Samodzielny Publiczny Szpital Kliniczny nr 5
  • Katedra i Klinika Endokrynologii
  • Centrum Diagnostyczno-Lecznicze "GAMMED"
  • Hospital Universitario Vall D'hebron
  • Hospital Universitario Ramón Y Cajal
  • Hospital Universitario 12 De Octubre
  • Hospital Universitario Central de Asturias
  • Queen Elizabeth Medical Center
  • Royal Free Hospital
  • The Christie Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lanreotide Autogel®

Arm Description

One subcutaneous (SC) injection of lanreotide Autogel® 120mg every 14 days until disease progression or death or unacceptable toxicity or tolerability.

Outcomes

Primary Outcome Measures

Median Progression Free Survival (PFS)
PFS was defined as the time from first injection of lanreotide Autogel® 120 mg every 14 days to progression or death. Disease progression was assessed by tumour response evaluation according to RECIST v1.0, every 12 weeks, measured by independent central review using the same imaging technique (computed tomography [CT] scan or magnetic resonance imaging [MRI]) for each subject throughout the study. The median PFS time was estimated using the Kaplan Meier method for each cohort.

Secondary Outcome Measures

Median Time to Progression
Time to Progression was defined as time from first injection of lanreotide Autogel® 120 mg every 14 days to progression. Disease progression was assessed by tumour response evaluation according to RECIST v1.0, every 12 weeks, measured by independent central review using the same imaging technique (CT scan or MRI) for each subject throughout the study. Median time to progression was estimated using the Kaplan Meier method for each cohort.
Percentage of Subjects Alive and Progression Free
The percentage of subjects alive and progression-free was assessed throughout the study up to Week 60 for the panNET cohort and Week 96 for the midgut cohort. Disease progression was assessed by tumour response evaluation according to RECIST v1.0, every 12 weeks measured by independent central review using the same imaging technique (CT scan or MRI) for each subject throughout the study. The percentage of subjects alive and progression free was estimated using the Kaplan Meier method for each cohort.
Overall Survival
Overall survival was defined as the time in months from the first injection of lanreotide Autogel® 120 mg every 14 days to death due to any cause. Median overall survival was estimated using the Kaplan Meier method for each cohort.
Objective Response Rate (ORR)
The ORR was defined as the percentage of subjects who achieve either complete response (CR) or partial response (PR) according to RECIST v1.0 criteria. ORR was evaluated every 12 weeks and results are presented for each cohort.
Disease Control Rate (DCR)
The DCR was defined as the percentage of subjects who achieved CR plus PR plus Stable Disease (SD), evaluated according to RECIST v1.0 criteria. The DCR at Weeks 24 and 48 is presented for each cohort.
Best Overall Response Rate
Best overall response was defined as the best response recorded from the initiation of treatment until disease progression, according to RECIST v1.0 evaluation. The percentage of subjects in each response category and those who were non-evaluable (i.e. with no tumour assessment after the start of study treatment) throughout the study are presented for each cohort.
Median Duration of Stable Disease
Median duration of SD was the time from first injection of lanreotide Autogel® 120 mg every 14 days until the first occurrence of PD by central assessment. Disease progression was assessed by tumour response evaluation according to RECIST v1.0, every 12 weeks, measured using the same imaging technique (CT scan or MRI) for each subject throughout the study. Median duration of stable disease was estimated using the Kaplan Meier method for each cohort.
Factors Associated With PFS
A univariate cox proportional hazards model was used to assess whether the following factors were associated with PFS: Hepatic tumour load: >25% versus reference ≤25% Tumour Grade: Grade 2 versus reference Grade 1, Previous surgery of the primary tumour: No versus reference Yes, Proliferation index Ki67: ≥10% versus reference <10% Duration of treatment with lanreotide Autogel® 120 mg every 28 days by category: ≥median value versus reference <median value, Age by category: ≥65 years versus reference <65 years, Time from diagnosis to study entry by category: ≥3 years versus reference <3 years, Time interval between the two CT scans (pre-screening/screening): ≥12 months versus reference <12 months and Symptoms (diarrhoea or flushing at baseline): No versus reference Yes. Each factor was assessed for its importance in the Cox model for PFS in a univariate fashion.
Mean Change From Baseline in Number of Stools and Flushing Episodes
Symptom control was measured by the total number of stools (diarrhoea) and flushing episodes during the 7 days prior to the visit, reported orally by the subject to the investigator. The mean change from baseline in number of stools and flushing episodes reported at each visit is presented for each cohort.
Mean Change From Baseline in QoL Measured Using EORTC, QLQ-C30 v3.0 (Global Health Status Sub-score)
Subjects were instructed to complete the 30 questions in the EORTC-QLQ-C30 v3.0 questionnaire at baseline and every 12 weeks throughout the study. The global health status sub-score was assessed using the last 2 questions which represented subject's assessment of overall health & QoL. Each question was coded on a 7-point scale (1=very poor to 7=excellent). The sub-score was transformed to range from 0-100, with a high score for global health status representing a high QoL. The mean change from baseline in the transformed global health status are presented for the end of study/early withdrawal visit, with a positive change indicating an improvement in QoL.
Mean Change From Baseline in EQ-5D-5L v1.0 Questionnaire (Descriptive System)
Subjects were instructed to complete the EQ-5D-5L descriptive system at baseline and every 12 weeks throughout the study. The EQ-5D-5L descriptive system comprised the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, extreme problems. The EQ-5D-5L health states, defined by the EQ-5D-5L descriptive system, was converted into a single index value with scores ranging from 0 (no problems) to 1 (extreme problems). The mean change from baseline at the end of study/early withdrawal visit is presented with a positive change from baseline in the index values indicating a worsening of symptoms.
Mean Change From Baseline in EQ-5D-5L v1.0 Questionnaire (VAS)
Subjects were instructed to complete the EQ-5D-5L VAS at baseline and every 12 weeks throughout the study. The EQ-5D-5L VAS recorded the subject's self-rated health on a vertical VAS which is numbered from 0 (worst health state) to 100 (best health state). The mean change from baseline at the end of study/early withdrawal visit is presented with a positive change in the VAS indicating an improvement in symptoms.
Mean Change From Baseline in QoL Questionnaire Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21; 2006)
Subjects were asked to complete the EORTC QLQ-GI.NET21 module which comprised 21 questions that used a 4-point scale (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much) to evaluate 3 defined multi-item symptom scales (endocrine, gastrointestinal and treatment related side effects), 2 single item symptoms (bone/muscle pain and concern about weight loss), 2 psychosocial scales (social function and disease-related worries) and 2 other single items (sexuality and communication). Answers were converted into grading scale, with values between 0 and 100. Each individual sub-score was transformed to range from 0 to 100. The mean change from baseline at the end of study/early withdrawal visit is presented with a higher score representing more or worse problems.
Mean Change From Baseline in Nonspecific Tumour Biomarkers
Nonspecific tumour peptide biomarkers (chromogranin A [CgA], neuron specific enolase [NSE] and plasma/urinary 5-hydroxyindoleacetic acid [5-HIAA]) were evaluated in both pancreas and midgut subjects at baseline and Week 12 and every 12 weeks thereafter. At all scheduled visits, except baseline, plasma/urinary 5-HIAA was only performed in subjects with symptoms of carcinoid syndrome (diarrhoea and/or flushing) or if urinary 5-HIAA was elevated (above upper limit of normal [ULN]) at baseline. Mean change from baseline values were normalised by the ULN (xULN) and are presented for each cohort.
Mean Change From Baseline in PanNet Specific Tumour Biomarkers: Pancreatic Polypeptide, Gastrin
PanNET specific tumour peptide biomarkers were evaluated in pancreas subjects at baseline. Only the tumour biomarkers that were above normal range at baseline were evaluated every 12 weeks thereafter and at the end of study visit. The mean change from baseline values in picomole/liter (pmol/L) are presented for the end of study visit.
Mean Change From Baseline in PanNet Specific Tumour Biomarkers: Glucagon
PanNET specific tumour peptide biomarkers were evaluated in pancreas subjects at baseline. Only the tumour biomarkers that were above normal range at baseline were evaluated every 12 weeks thereafter and at the end of study visit. The mean change from baseline values in nanograms (ng)/L are presented for the end of study visit.

Full Information

First Posted
December 11, 2015
Last Updated
September 21, 2022
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT02651987
Brief Title
Efficacy and Safety Study in Pancreatic or Midgut Neuroendocrine Tumours Having Progressed Radiologically While Previously Treated With Lanreotide Autogel® 120 mg
Acronym
CLARINET FORTE
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 Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
December 15, 2015 (Actual)
Primary Completion Date
October 16, 2019 (Actual)
Study Completion Date
October 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Tumours, Midgut Neuroendocrine Tumours

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lanreotide Autogel®
Arm Type
Experimental
Arm Description
One subcutaneous (SC) injection of lanreotide Autogel® 120mg every 14 days until disease progression or death or unacceptable toxicity or tolerability.
Intervention Type
Drug
Intervention Name(s)
Lanreotide autogel 120 mg
Primary Outcome Measure Information:
Title
Median Progression Free Survival (PFS)
Description
PFS was defined as the time from first injection of lanreotide Autogel® 120 mg every 14 days to progression or death. Disease progression was assessed by tumour response evaluation according to RECIST v1.0, every 12 weeks, measured by independent central review using the same imaging technique (computed tomography [CT] scan or magnetic resonance imaging [MRI]) for each subject throughout the study. The median PFS time was estimated using the Kaplan Meier method for each cohort.
Time Frame
From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort
Secondary Outcome Measure Information:
Title
Median Time to Progression
Description
Time to Progression was defined as time from first injection of lanreotide Autogel® 120 mg every 14 days to progression. Disease progression was assessed by tumour response evaluation according to RECIST v1.0, every 12 weeks, measured by independent central review using the same imaging technique (CT scan or MRI) for each subject throughout the study. Median time to progression was estimated using the Kaplan Meier method for each cohort.
Time Frame
From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort
Title
Percentage of Subjects Alive and Progression Free
Description
The percentage of subjects alive and progression-free was assessed throughout the study up to Week 60 for the panNET cohort and Week 96 for the midgut cohort. Disease progression was assessed by tumour response evaluation according to RECIST v1.0, every 12 weeks measured by independent central review using the same imaging technique (CT scan or MRI) for each subject throughout the study. The percentage of subjects alive and progression free was estimated using the Kaplan Meier method for each cohort.
Time Frame
Weeks 12, 24, 36, 48, 60 (for both cohorts) and Weeks 72, 84 and 96 (for midgut NET cohort)
Title
Overall Survival
Description
Overall survival was defined as the time in months from the first injection of lanreotide Autogel® 120 mg every 14 days to death due to any cause. Median overall survival was estimated using the Kaplan Meier method for each cohort.
Time Frame
From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort
Title
Objective Response Rate (ORR)
Description
The ORR was defined as the percentage of subjects who achieve either complete response (CR) or partial response (PR) according to RECIST v1.0 criteria. ORR was evaluated every 12 weeks and results are presented for each cohort.
Time Frame
Weeks 12, 24, 36, 48, 60 (for both cohorts) and Weeks 72, 84, and 96 (for midgut cohort)
Title
Disease Control Rate (DCR)
Description
The DCR was defined as the percentage of subjects who achieved CR plus PR plus Stable Disease (SD), evaluated according to RECIST v1.0 criteria. The DCR at Weeks 24 and 48 is presented for each cohort.
Time Frame
Weeks 24 and 48
Title
Best Overall Response Rate
Description
Best overall response was defined as the best response recorded from the initiation of treatment until disease progression, according to RECIST v1.0 evaluation. The percentage of subjects in each response category and those who were non-evaluable (i.e. with no tumour assessment after the start of study treatment) throughout the study are presented for each cohort.
Time Frame
From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort
Title
Median Duration of Stable Disease
Description
Median duration of SD was the time from first injection of lanreotide Autogel® 120 mg every 14 days until the first occurrence of PD by central assessment. Disease progression was assessed by tumour response evaluation according to RECIST v1.0, every 12 weeks, measured using the same imaging technique (CT scan or MRI) for each subject throughout the study. Median duration of stable disease was estimated using the Kaplan Meier method for each cohort.
Time Frame
From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort
Title
Factors Associated With PFS
Description
A univariate cox proportional hazards model was used to assess whether the following factors were associated with PFS: Hepatic tumour load: >25% versus reference ≤25% Tumour Grade: Grade 2 versus reference Grade 1, Previous surgery of the primary tumour: No versus reference Yes, Proliferation index Ki67: ≥10% versus reference <10% Duration of treatment with lanreotide Autogel® 120 mg every 28 days by category: ≥median value versus reference <median value, Age by category: ≥65 years versus reference <65 years, Time from diagnosis to study entry by category: ≥3 years versus reference <3 years, Time interval between the two CT scans (pre-screening/screening): ≥12 months versus reference <12 months and Symptoms (diarrhoea or flushing at baseline): No versus reference Yes. Each factor was assessed for its importance in the Cox model for PFS in a univariate fashion.
Time Frame
Screening/Baseline (Day 1)
Title
Mean Change From Baseline in Number of Stools and Flushing Episodes
Description
Symptom control was measured by the total number of stools (diarrhoea) and flushing episodes during the 7 days prior to the visit, reported orally by the subject to the investigator. The mean change from baseline in number of stools and flushing episodes reported at each visit is presented for each cohort.
Time Frame
Baseline (Day 1), Weeks 8,12, 48 and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET cohort)
Title
Mean Change From Baseline in QoL Measured Using EORTC, QLQ-C30 v3.0 (Global Health Status Sub-score)
Description
Subjects were instructed to complete the 30 questions in the EORTC-QLQ-C30 v3.0 questionnaire at baseline and every 12 weeks throughout the study. The global health status sub-score was assessed using the last 2 questions which represented subject's assessment of overall health & QoL. Each question was coded on a 7-point scale (1=very poor to 7=excellent). The sub-score was transformed to range from 0-100, with a high score for global health status representing a high QoL. The mean change from baseline in the transformed global health status are presented for the end of study/early withdrawal visit, with a positive change indicating an improvement in QoL.
Time Frame
Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET (and overall) cohort)
Title
Mean Change From Baseline in EQ-5D-5L v1.0 Questionnaire (Descriptive System)
Description
Subjects were instructed to complete the EQ-5D-5L descriptive system at baseline and every 12 weeks throughout the study. The EQ-5D-5L descriptive system comprised the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, extreme problems. The EQ-5D-5L health states, defined by the EQ-5D-5L descriptive system, was converted into a single index value with scores ranging from 0 (no problems) to 1 (extreme problems). The mean change from baseline at the end of study/early withdrawal visit is presented with a positive change from baseline in the index values indicating a worsening of symptoms.
Time Frame
Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET (and overall) cohort)
Title
Mean Change From Baseline in EQ-5D-5L v1.0 Questionnaire (VAS)
Description
Subjects were instructed to complete the EQ-5D-5L VAS at baseline and every 12 weeks throughout the study. The EQ-5D-5L VAS recorded the subject's self-rated health on a vertical VAS which is numbered from 0 (worst health state) to 100 (best health state). The mean change from baseline at the end of study/early withdrawal visit is presented with a positive change in the VAS indicating an improvement in symptoms.
Time Frame
Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET (and overall) cohort)
Title
Mean Change From Baseline in QoL Questionnaire Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21; 2006)
Description
Subjects were asked to complete the EORTC QLQ-GI.NET21 module which comprised 21 questions that used a 4-point scale (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much) to evaluate 3 defined multi-item symptom scales (endocrine, gastrointestinal and treatment related side effects), 2 single item symptoms (bone/muscle pain and concern about weight loss), 2 psychosocial scales (social function and disease-related worries) and 2 other single items (sexuality and communication). Answers were converted into grading scale, with values between 0 and 100. Each individual sub-score was transformed to range from 0 to 100. The mean change from baseline at the end of study/early withdrawal visit is presented with a higher score representing more or worse problems.
Time Frame
Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET (and overall) cohort)
Title
Mean Change From Baseline in Nonspecific Tumour Biomarkers
Description
Nonspecific tumour peptide biomarkers (chromogranin A [CgA], neuron specific enolase [NSE] and plasma/urinary 5-hydroxyindoleacetic acid [5-HIAA]) were evaluated in both pancreas and midgut subjects at baseline and Week 12 and every 12 weeks thereafter. At all scheduled visits, except baseline, plasma/urinary 5-HIAA was only performed in subjects with symptoms of carcinoid syndrome (diarrhoea and/or flushing) or if urinary 5-HIAA was elevated (above upper limit of normal [ULN]) at baseline. Mean change from baseline values were normalised by the ULN (xULN) and are presented for each cohort.
Time Frame
Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET cohort)
Title
Mean Change From Baseline in PanNet Specific Tumour Biomarkers: Pancreatic Polypeptide, Gastrin
Description
PanNET specific tumour peptide biomarkers were evaluated in pancreas subjects at baseline. Only the tumour biomarkers that were above normal range at baseline were evaluated every 12 weeks thereafter and at the end of study visit. The mean change from baseline values in picomole/liter (pmol/L) are presented for the end of study visit.
Time Frame
Baseline (Day 1) and end of study (approximately 64 weeks)
Title
Mean Change From Baseline in PanNet Specific Tumour Biomarkers: Glucagon
Description
PanNET specific tumour peptide biomarkers were evaluated in pancreas subjects at baseline. Only the tumour biomarkers that were above normal range at baseline were evaluated every 12 weeks thereafter and at the end of study visit. The mean change from baseline values in nanograms (ng)/L are presented for the end of study visit.
Time Frame
Baseline (Day 1) and end of study (approximately 64 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Erasme Hospital
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Cliniques Unversitaires Saint Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Antwerp University Hospital
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Aarhus University Hospital
City
Aarhus
Country
Denmark
Facility Name
Rigshospitalet
City
København
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Hôpital Beaujon
City
Clichy
ZIP/Postal Code
92118
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Institut Paoli Calmette
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Charité - CVK
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Nationales Centrum für Tumorerkrankungen (NCT)
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
St Vincent's University Hospital
City
Dublin
ZIP/Postal Code
D4
Country
Ireland
Facility Name
IRCCS Azienda Ospedaliera Universitaria
City
San Martino
State/Province
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Azienda Ospedaliera - Universitaria Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Fondacione IRCCS Istituto Nazionale Dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Università degli Studi "Federico II" di Napoli
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliera sant'Andrea
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
AVL/NKI Medisch Oncologie
City
Amsterdam
ZIP/Postal Code
1066
Country
Netherlands
Facility Name
Academic Medical Center
City
Amsterdam
ZIP/Postal Code
1105
Country
Netherlands
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015
Country
Netherlands
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 5
City
Katowice
ZIP/Postal Code
40-952
Country
Poland
Facility Name
Katedra i Klinika Endokrynologii
City
Poznan
ZIP/Postal Code
60-355
Country
Poland
Facility Name
Centrum Diagnostyczno-Lecznicze "GAMMED"
City
Warsaw
ZIP/Postal Code
02-348
Country
Poland
Facility Name
Hospital Universitario Vall D'hebron
City
Barcelona
ZIP/Postal Code
08034
Country
Spain
Facility Name
Hospital Universitario Ramón Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 De Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
Queen Elizabeth Medical Center
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
The Christie Hospital NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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