Phase 2
N=99
Efficacy and Safety Study in Pancreatic or Midgut Neuroendocrine Tumours Having Progressed Radiologically While Previously Treated With Lanreotide Autogel® 120 mg
Pancreatic Tumours · Midgut Neuroendocrine Tumours
Bottom Line
View on ClinicalTrials.gov: NCT02651987 ↗Enrolled (actual)
99
Serious AEs
18.2%
Results posted
Dec 2020
Primary outcome: Primary: Median Progression Free Survival (PFS) — 5.6; 8.3 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lanreotide autogel 120 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ipsen
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Progression Free Survival (PFS) |
5.6; 8.3 | — |
| SECONDARY Median Time to Progression |
5.6; 8.7 | — |
| SECONDARY Percentage of Subjects Alive and Progression Free |
93.3; 91.8; 64.4; 65.3; 37.8; 59.2 | — |
| SECONDARY Overall Survival |
NA; NA | — |
| SECONDARY Objective Response Rate (ORR) |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Disease Control Rate (DCR) |
43.8; 58.8; 22.9; 33.3 | — |
| SECONDARY Best Overall Response Rate |
0.0; 0.0; 0.0; 3.9; 66.7; 68.6 | — |
| SECONDARY Median Duration of Stable Disease |
8.3; 13.8 | — |
| SECONDARY Factors Associated With PFS |
0.96; 1.54; 0.68; 0.90; 1.04; 2.14 | — |
| SECONDARY Mean Change From Baseline in Number of Stools and Flushing Episodes |
1.0; -1.0; -1.2; 0.7; -1.0; 3.4 | — |
| SECONDARY Mean Change From Baseline in QoL Measured Using EORTC, QLQ-C30 v3.0 (Global Health Status Sub-score) |
-0.38; -1.33; -0.89 | — |
| SECONDARY Mean Change From Baseline in EQ-5D-5L v1.0 Questionnaire (Descriptive System) |
-0.04; 0.00; -0.02 | — |
| SECONDARY Mean Change From Baseline in EQ-5D-5L v1.0 Questionnaire (VAS) |
-1.90; -1.76; -1.83 | — |
| SECONDARY Mean Change From Baseline in QoL Questionnaire Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21; 2006) |
-0.53; -5.09; -2.96; -3.49; -2.78; -3.11 | — |
| SECONDARY Mean Change From Baseline in Nonspecific Tumour Biomarkers |
0.205; 0.370; 0.03; -0.49; -0.42; 3.90 | — |
| SECONDARY Mean Change From Baseline in PanNet Specific Tumour Biomarkers: Pancreatic Polypeptide, Gastrin |
82.7; -9.8 | — |
| SECONDARY Mean Change From Baseline in PanNet Specific Tumour Biomarkers: Glucagon |
5.5 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02651987). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.