Efficacy and Safety Study in Pancreatic or Midgut Neuroendocrine Tumours Having Progressed Radiologically While Previously Treated With Lanreotide Autogel® 120 mg
CompletedPhase 2Results postedLast updated 3 October 2022
What this trial tests
Phase 2 trial testing Lanreotide autogel 120 mg in Pancreatic Tumours in 99 participants. Completed in 24 October 2019.
18 and older, any sex, with Pancreatic Tumours or Midgut Neuroendocrine Tumours. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Median Progression Free Survival (PFS)Primary· From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort
PFS was defined as the time from first injection of lanreotide Autogel® 120 mg every 14 days to progression or death. Disease progression was assessed by tumour response evaluation according to RECIST v1.0, every 12 weeks, measured by independent central review using the same imaging technique (computed tomography \[CT\] scan or magnetic resonance imaging \[MRI\]) for each subject throughout the study. The median PFS time was estimated using the Kaplan Meier method for each cohort.
Group
Value
95% CI
PanNET Cohort
5.6
5.5 – 8.3
Midgut NET Cohort
8.3
5.6 – 11.1
Median Time to ProgressionSecondary· From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort
Time to Progression was defined as time from first injection of lanreotide Autogel® 120 mg every 14 days to progression. Disease progression was assessed by tumour response evaluation according to RECIST v1.0, every 12 weeks, measured by independent central review using the same imaging technique (CT scan or MRI) for each subject throughout the study. Median time to progression was estimated using the Kaplan Meier method for each cohort.
Group
Value
95% CI
PanNET Cohort
5.6
5.5 – 8.3
Midgut NET Cohort
8.7
8.3 – 13.9
Percentage of Subjects Alive and Progression FreeSecondary· Weeks 12, 24, 36, 48, 60 (for both cohorts) and Weeks 72, 84 and 96 (for midgut NET cohort)
The percentage of subjects alive and progression-free was assessed throughout the study up to Week 60 for the panNET cohort and Week 96 for the midgut cohort. Disease progression was assessed by tumour response evaluation according to RECIST v1.0, every 12 weeks measured by independent central review using the same imaging technique (CT scan or MRI) for each subject throughout the study. The percentage of subjects alive and progression free was estimated using the Kaplan Meier method for each cohort.
Week 12
Group
Value
95% CI
PanNET Cohort
93.3
80.7 – 97.8
Midgut NET Cohort
91.8
79.7 – 96.9
Week 24
Group
Value
95% CI
PanNET Cohort
64.4
48.7 – 76.5
Midgut NET Cohort
65.3
50.3 – 76.8
Week 36
Group
Value
95% CI
PanNET Cohort
37.8
23.9 – 51.6
Midgut NET Cohort
59.2
44.2 – 71.4
Week 48
Group
Value
95% CI
PanNET Cohort
28.5
16.2 – 42.1
Midgut NET Cohort
38.3
24.8 – 51.6
Week 60
Group
Value
95% CI
PanNET Cohort
20.7
9.0 – 35.7
Midgut NET Cohort
36.1
22.9 – 49.5
Week 72
Group
Value
95% CI
Midgut NET Cohort
29.8
17.6 – 42.9
Week 84
Group
Value
95% CI
Midgut NET Cohort
27.5
15.7 – 40.5
Week 96
Group
Value
95% CI
Midgut NET Cohort
25.2
13.9 – 38.1
Overall SurvivalSecondary· From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort
Overall survival was defined as the time in months from the first injection of lanreotide Autogel® 120 mg every 14 days to death due to any cause. Median overall survival was estimated using the Kaplan Meier method for each cohort.
Group
Value
95% CI
PanNET Cohort
NA
NA – NA
Midgut NET Cohort
NA
NA – NA
Objective Response Rate (ORR)Secondary· Weeks 12, 24, 36, 48, 60 (for both cohorts) and Weeks 72, 84, and 96 (for midgut cohort)
The ORR was defined as the percentage of subjects who achieve either complete response (CR) or partial response (PR) according to RECIST v1.0 criteria. ORR was evaluated every 12 weeks and results are presented for each cohort.
Week 12
Group
Value
95% CI
PanNET Cohort
0.0
0.0 – 7.4
Midgut NET Cohort
0.0
0.0 – 7.0
Week 24
Group
Value
95% CI
PanNET Cohort
0.0
0.0 – 7.4
Midgut NET Cohort
0.0
0.0 – 7.0
Week 36
Group
Value
95% CI
PanNET Cohort
0.0
0.0 – 7.4
Midgut NET Cohort
0.0
0.0 – 7.0
Week 48
Group
Value
95% CI
PanNET Cohort
0.0
0.0 – 7.4
Midgut NET Cohort
0.0
0.0 – 7.0
Week 60
Group
Value
95% CI
PanNET Cohort
0.0
0.0 – 7.4
Midgut NET Cohort
2.0
0.0 – 10.4
Week 72
Group
Value
95% CI
Midgut NET Cohort
3.9
0.5 – 13.5
Week 84
Group
Value
95% CI
Midgut NET Cohort
2.0
0.0 – 10.4
Week 96
Group
Value
95% CI
Midgut NET Cohort
2.0
0.0 – 10.4
Disease Control Rate (DCR)Secondary· Weeks 24 and 48
The DCR was defined as the percentage of subjects who achieved CR plus PR plus Stable Disease (SD), evaluated according to RECIST v1.0 criteria. The DCR at Weeks 24 and 48 is presented for each cohort.
Week 24
Group
Value
95% CI
PanNET Cohort
43.8
29.5 – 58.8
Midgut NET Cohort
58.8
44.2 – 72.4
Week 48
Group
Value
95% CI
PanNET Cohort
22.9
12.0 – 37.3
Midgut NET Cohort
33.3
20.8 – 47.9
Best Overall Response RateSecondary· From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort
Best overall response was defined as the best response recorded from the initiation of treatment until disease progression, according to RECIST v1.0 evaluation. The percentage of subjects in each response category and those who were non-evaluable (i.e. with no tumour assessment after the start of study treatment) throughout the study are presented for each cohort.
CR
Group
Value
95% CI
PanNET Cohort
0.0
0.0 – 7.4
Midgut NET Cohort
0.0
0.0 – 7.0
PR
Group
Value
95% CI
PanNET Cohort
0.0
0.0 – 7.4
Midgut NET Cohort
3.9
0.5 – 13.5
SD
Group
Value
95% CI
PanNET Cohort
66.7
51.6 – 79.6
Midgut NET Cohort
68.6
54.1 – 80.9
PD
Group
Value
95% CI
PanNET Cohort
31.3
18.7 – 46.3
Midgut NET Cohort
23.5
12.8 – 37.5
Not evaluable
Group
Value
95% CI
PanNET Cohort
0.0
0.0 – 7.4
Midgut NET Cohort
2.0
0.0 – 10.4
Median Duration of Stable DiseaseSecondary· From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort
Median duration of SD was the time from first injection of lanreotide Autogel® 120 mg every 14 days until the first occurrence of PD by central assessment. Disease progression was assessed by tumour response evaluation according to RECIST v1.0, every 12 weeks, measured using the same imaging technique (CT scan or MRI) for each subject throughout the study. Median duration of stable disease was estimated using the Kaplan Meier method for each cohort.
Group
Value
95% CI
PanNET Cohort
8.3
8.0 – 13.8
Midgut NET Cohort
13.8
8.6 – NA
Factors Associated With PFSSecondary· Screening/Baseline (Day 1)
A univariate cox proportional hazards model was used to assess whether the following factors were associated with PFS:
* Hepatic tumour load: \>25% versus reference ≤25%
* Tumour Grade: Grade 2 versus reference Grade 1,
* Previous surgery of the primary tumour: No versus reference Yes,
* Proliferation index Ki67: ≥10% versus reference \<10%
* Duration of treatment with lanreotide Autogel® 120 mg every 28 days by category: ≥median value versus reference \<median value,
* Age by category: ≥65 years versus reference \<65 years,
* Time from diagnosis to study entry by category: ≥3 years versus re
Hepatic tumour load: >25% Vs ≤25%
Group
Value
95% CI
PanNET Cohort
0.96
0.40 – 2.32
Midgut NET Cohort
1.54
0.70 – 3.40
Tumour Grade: 2 Vs 1
Group
Value
95% CI
PanNET Cohort
0.68
0.32 – 1.45
Midgut NET Cohort
0.90
0.46 – 1.77
Previous surgery: No Vs Yes
Group
Value
95% CI
PanNET Cohort
1.04
0.53 – 2.04
Midgut NET Cohort
2.14
0.83 – 5.52
Ki67: ≥10% Vs <10%
Group
Value
95% CI
PanNET Cohort
3.60
1.39 – 9.32
Midgut NET Cohort
2.26
0.67 – 7.60
Duration of treatment with lanreotide Autogel® 120 mg every 28 days: ≥median Vs <median
Group
Value
95% CI
PanNET Cohort
0.68
0.34 – 1.34
Midgut NET Cohort
0.76
0.40 – 1.47
Age: ≥65 years Vs <65 years
Group
Value
95% CI
PanNET Cohort
1.55
0.79 – 3.06
Midgut NET Cohort
1.15
0.58 – 2.31
Time from diagnosis: ≥3 years Vs <3 years
Group
Value
95% CI
PanNET Cohort
0.49
0.25 – 0.96
Midgut NET Cohort
0.94
0.49 – 1.82
Time between CT scans: ≥12 months Vs <12 months
Group
Value
95% CI
PanNET Cohort
0.47
0.24 – 0.94
Midgut NET Cohort
0.72
0.37 – 1.39
Mean Change From Baseline in Number of Stools and Flushing EpisodesSecondary· Baseline (Day 1), Weeks 8,12, 48 and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET cohort)
Symptom control was measured by the total number of stools (diarrhoea) and flushing episodes during the 7 days prior to the visit, reported orally by the subject to the investigator. The mean change from baseline in number of stools and flushing episodes reported at each visit is presented for each cohort.
Stools - Week 8
Group
Value
95% CI
PanNET Cohort
1.0
± 5.5
Midgut NET Cohort
-1.0
± 8.2
Stools - Week 12
Group
Value
95% CI
PanNET Cohort
-1.2
± 7.9
Midgut NET Cohort
0.7
± 2.5
Stools - Week 48
Group
Value
95% CI
PanNET Cohort
-1.0
± 0.0
Midgut NET Cohort
3.4
± 4.8
Stools - End of Study
Group
Value
95% CI
PanNET Cohort
0.5
± 5.4
Midgut NET Cohort
-1.2
± 12.2
Flushing - Week 8
Group
Value
95% CI
PanNET Cohort
0.7
± 2.1
Midgut NET Cohort
-3.3
± 8.3
Flushing - Week 12
Group
Value
95% CI
PanNET Cohort
-1.0
± 0.0
Midgut NET Cohort
1.5
± 10.0
Flushing - Week 48
Group
Value
95% CI
PanNET Cohort
-1.0
± 0.0
Midgut NET Cohort
-1.5
± 2.1
Flushing - End of Study
Group
Value
95% CI
PanNET Cohort
0.0
± 1.4
Midgut NET Cohort
-0.5
± 6.2
Mean Change From Baseline in QoL Measured Using EORTC, QLQ-C30 v3.0 (Global Health Status Sub-score)Secondary· Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET (and overall) cohort)
Subjects were instructed to complete the 30 questions in the EORTC-QLQ-C30 v3.0 questionnaire at baseline and every 12 weeks throughout the study.
The global health status sub-score was assessed using the last 2 questions which represented subject's assessment of overall health \& QoL. Each question was coded on a 7-point scale (1=very poor to 7=excellent). The sub-score was transformed to range from 0-100, with a high score for global health status representing a high QoL. The mean change from baseline in the transformed global health status are presented for the end of study/early withdrawa
Group
Value
95% CI
PanNET Cohort
-0.38
± 15.32
Midgut NET Cohort
-1.33
± 17.13
Overall
-0.89
± 16.14
Mean Change From Baseline in EQ-5D-5L v1.0 Questionnaire (Descriptive System)Secondary· Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET (and overall) cohort)
Subjects were instructed to complete the EQ-5D-5L descriptive system at baseline and every 12 weeks throughout the study.
The EQ-5D-5L descriptive system comprised the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, extreme problems. The EQ-5D-5L health states, defined by the EQ-5D-5L descriptive system, was converted into a single index value with scores ranging from 0 (no problems) to 1 (extreme problems). The mean change from baseline at the
Group
Value
95% CI
PanNET Cohort
-0.04
± 0.12
Midgut NET Cohort
0.00
± 0.11
Overall
-0.02
± 0.12
Adverse events — posted to ClinicalTrials.gov
Time frame: Treatment emergent adverse events were recorded from the first dose of lanreotide Autogel® 120 mg on Day 1 until 28 days after the last treatment. Overall time frame of up to a maximum of 64 weeks for panNET cohort and 108 weeks for midgut NET (and overall) cohort..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
PanNET Cohort
Serious: 5/48 (10%)
Deaths: 1/48
Midgut NET Cohort
Serious: 13/51 (25%)
Deaths: 3/51
Overall Subjects
Serious: 18/99 (18%)
Deaths: 4/99
Serious adverse events (20 terms)
Reaction
System
PanNET Cohort
Midgut NET Cohort
Overall Subjects
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
—
—
Cardiac failure
Cardiac disorders
—
—
—
Pulseless electrical activity
Cardiac disorders
—
—
—
Abdominal pain
Gastrointestinal disorders
—
—
—
Diarrhoea
Gastrointestinal disorders
—
—
—
Intestinal obstruction
Gastrointestinal disorders
—
—
—
Asthenia
General disorders
—
—
—
Chest pain
General disorders
—
—
—
General physical health deterioration
General disorders
—
—
—
Anaphylactic reaction
Immune system disorders
—
—
—
Peritonitis
Infections and infestations
—
—
—
Viral infection
Infections and infestations
—
—
—
Craniocerebral injury
Injury, poisoning and procedural complications
—
—
—
Fall
Injury, poisoning and procedural complications
—
—
—
Spinal fracture
Injury, poisoning and procedural complications
—
—
—
Bone neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Spinal cord compression
Nervous system disorders
—
—
—
Syncope
Nervous system disorders
—
—
—
Hypotension
Vascular disorders
—
—
—
Other adverse events (207 terms — click to expand)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ipsen
Last refreshed: 3 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02651987.