Clinical Trial: NCT02651987 - My Cancer Genome

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:

Completed

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT02651987

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

Drug	Synonyms	Arms
Lanreotide autogel 120 mg		Lanreotide Autogel®

Purpose

Trial Arms

Name	Type	Description	Interventions
Lanreotide Autogel®	Experimental	One 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

Clinical Trials /

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