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.
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
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
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