Clinical trial NCT02651987: Efficacy and Safety Study in Pancreatic or Midgut Neuroendocrine Tumours Having Progressed Radiologically While Previously Treated With Lanreotide Autogel® 120 mg
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Tumours
Midgut Neuroendocrine Tumours
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2016-01-11
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Median Progression Free Survival (PFS)
timeFrame: From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort
Secondary outcomes:
measure: Median Time to Progression
timeFrame: From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort
measure: Percentage of Subjects Alive and Progression Free
timeFrame: Weeks 12, 24, 36, 48, 60 (for both cohorts) and Weeks 72, 84 and 96 (for midgut NET cohort)
measure: Overall Survival
timeFrame: From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort
measure: Objective Response Rate (ORR)
timeFrame: Weeks 12, 24, 36, 48, 60 (for both cohorts) and Weeks 72, 84, and 96 (for midgut cohort)
measure: Disease Control Rate (DCR)
timeFrame: Weeks 24 and 48
measure: Best Overall Response Rate
timeFrame: From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort
measure: Median Duration of Stable Disease
timeFrame: From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort
measure: Factors Associated With PFS
timeFrame: Screening/Baseline (Day 1)
measure: Mean Change From Baseline in Number of Stools and Flushing Episodes
timeFrame: Baseline (Day 1), Weeks 8,12, 48 and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET cohort)
measure: Mean Change From Baseline in QoL Measured Using EORTC, QLQ-C30 v3.0 (Global Health Status Sub-score)
timeFrame: Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET (and overall) cohort)
measure: Mean Change From Baseline in EQ-5D-5L v1.0 Questionnaire (Descriptive System)
timeFrame: Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET (and overall) cohort)
measure: Mean Change From Baseline in EQ-5D-5L v1.0 Questionnaire (VAS)
timeFrame: Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET (and overall) cohort)
measure: Mean Change From Baseline in QoL Questionnaire Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21; 2006)
timeFrame: Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET (and overall) cohort)
measure: Mean Change From Baseline in Nonspecific Tumour Biomarkers
timeFrame: Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET cohort)
measure: Mean Change From Baseline in PanNet Specific Tumour Biomarkers: Pancreatic Polypeptide, Gastrin
timeFrame: Baseline (Day 1) and end of study (approximately 64 weeks)
measure: Mean Change From Baseline in PanNet Specific Tumour Biomarkers: Glucagon
timeFrame: Baseline (Day 1) and end of study (approximately 64 weeks)
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Erasme Hospital
city: Bruxelles
country: Belgium
facility: Cliniques Unversitaires Saint Luc
city: Edegem
country: Belgium
facility: Antwerp University Hospital
city: Leuven
country: Belgium
facility: UZ Leuven
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: København
country: Denmark
facility: Rigshospitalet
city: Clichy
country: France
facility: Hôpital Beaujon
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Marseille
country: France
facility: Institut Paoli Calmette
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Berlin
country: Germany
facility: Charité - CVK
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Heidelberg
country: Germany
facility: Nationales Centrum für Tumorerkrankungen (NCT)
city: Dublin
country: Ireland
facility: St Vincent's University Hospital
city: San Martino
country: Italy
facility: IRCCS Azienda Ospedaliera Universitaria
state: Genova
city: Firenze
country: Italy
facility: Azienda Ospedaliera - Universitaria Careggi
city: Milano
country: Italy
facility: Fondacione IRCCS Istituto Nazionale Dei Tumori
city: Napoli
country: Italy
facility: Università degli Studi "Federico II" di Napoli
city: Roma
country: Italy
facility: Azienda Ospedaliera sant'Andrea
city: Amsterdam
country: Netherlands
facility: AVL/NKI Medisch Oncologie
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Katowice
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 5
city: Poznan
country: Poland
facility: Katedra i Klinika Endokrynologii
city: Warsaw
country: Poland
facility: Centrum Diagnostyczno-Lecznicze "GAMMED"
city: Barcelona
country: Spain
facility: Hospital Universitario Vall D'hebron
city: Madrid
country: Spain
facility: Hospital Universitario Ramón Y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 De Octubre
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Medical Center
city: London
country: United Kingdom
facility: Royal Free Hospital
city: Manchester
country: United Kingdom
facility: The Christie Hospital NHS Foundation Trust
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: