Clinical Trials /

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

NCT02651987

Description:

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.

Related Conditions:
  • Colon Neuroendocrine Neoplasm
  • Gastric Neuroendocrine Tumor
  • Pancreatic Neuroendocrine Tumor
  • Small Intestinal Neuroendocrine Tumor
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: 8-79-52030-326
  • SECONDARY ID: 2014-005607-24
  • NCT ID: NCT02651987

Conditions

  • Pancreatic Tumours
  • Midgut Neuroendocrine Tumours

Interventions

DrugSynonymsArms
Lanreotide autogel 120 mgLanreotide Autogel®

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Lanreotide Autogel®ExperimentalOne subcutaneous (SC) injection of lanreotide Autogel® 120mg every 14 days until disease progression or death or unacceptable toxicity or tolerability.
  • Lanreotide autogel 120 mg

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Median Progression Free Survival (PFS) Time
Time Frame:Every 14 days up to approximately 102 weeks
Safety Issue:
Description: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

Measure:Median Time to Progression
Time Frame:Every 14 days up to approximately 102 weeks
Safety Issue:
Description:Time to Progression is defined as time from first injection of lanreotide Autogel® 120 mg every 14 days to progression
Measure:Proportion of subjects alive and without progression
Time Frame:Every 12 weeks up to approximately 102 weeks
Safety Issue:
Description:Proportion of subjects alive and without progression every 12 weeks
Measure:Overall survival
Time Frame:Week 48 and at end of the study (up to approximately 102 weeks)
Safety Issue:
Description:Overall survival defined as the time from first study treatment to death due to any cause
Measure:Overall Response Rate (ORR)
Time Frame:Every 12 weeks up to approximately 102 weeks
Safety Issue:
Description: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).
Measure:Disease control rate (DCR)
Time Frame:Weeks 24, 48 and at end of the study (up to approximately 102 weeks)
Safety Issue:
Description:The DCR is defined as the rate of CR plus PR plus Stable Disease (SD). DCR evaluated according to RECIST v1.0
Measure:Best overall response
Time Frame:At end of the study (up to approximately 102 weeks)
Safety Issue:
Description:Best overall response according to RECIST v1.0 defined as the best response recorded from the initiation of treatment until disease progression
Measure:Median duration of Stable Disease (SD)
Time Frame:Every 14 days up to approximately 102 weeks
Safety Issue:
Description: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
Measure: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)
Safety Issue:
Description: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.
Measure:Change in Quality of life (QLQ-C30) from baseline
Time Frame:Every 12 weeks up to approximately 102 weeks
Safety Issue:
Description: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.
Measure:Change in Quality of life (QLQ-GI.NET21) from baseline
Time Frame:Every 12 weeks up to approximately 102 weeks
Safety Issue:
Description:Change in Quality of life from baseline every 12 weeks measured using Quality of Life Questionnaire Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21; 2006)
Measure:Change in Quality of life (EQ-5D-5L) from baseline
Time Frame:Every 12 weeks up to approximately 102 weeks
Safety Issue:
Description:Change in Quality of life from baseline every 12 weeks measured using EuroQoL 5 dimensions, 5 levels (EQ-5D-5L) v1.0 questionnaire.
Measure:Change in tumour biomarker concentrations from baseline
Time Frame:Baseline, Weeks 2 and 12 and every 12 weeks thereafter, up to approximately 102 weeks
Safety Issue:
Description: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)

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Ipsen

Last Updated

July 28, 2017