Anti-tumour effects of lanreotide for pancreatic and intestinal neuroendocrine tumours: the CLARINET open-label extension study.

Caplin ME, Pavel M, Ćwikła JB, Phan AT, Raderer M, Sedláčková E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Gomez-Panzani E, Ruszniewski P

Endocrine-related cancer7 Jan 2016Cited by 176 (Europe PMC)

PMID26743120PMCIDPMC4740728DOI10.1530/erc-15-0490PepBankPUB-26743120

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Summary

In the CLARINET study, lanreotide Autogel (depot in USA) significantly prolonged progression-free survival (PFS) in patients with metastatic pancreatic/intestinal neuroendocrine tumours (NETs). We report long-term safety and additional efficacy data from the open-label extension (OLE). Patients with metastatic grade 1/2 (Ki-67 ≤ 10%) non-functioning NET and documented baseline tumour-progression status received lanreotide Autogel 120 mg (n = 101) or placebo (n = 103) for 96 weeks or until death/progressive disease (PD) in CLARINET study. Patients with stable disease (SD) at core study end (lanreotide/placebo) or PD (placebo only) continued or switched to lanreotide in the OLE. In total, 88 patients (previously: lanreotide, n = 41; placebo, n = 47) participated: 38% had pancreatic, 39% midgut and 23% other/unknown primary tumours. Patients continuing lanreotide reported fewer adverse events (AEs) (all and treatment-related) during OLE than core study. Placebo-to-lanreotide switch patients reported similar AE rates in OLE and core studies, except more diarrhoea was considered treatment-related in OLE (overall diarrhoea unchanged). Median lanreotide PFS (core study randomisation to PD in core/OLE; n=101) was 32.8 months (95% CI: 30.9, 68.0). A sensitivity analysis, addressing potential selection bias by assuming that patients with SD on lanreotide in the core study and not entering the OLE (n=13) had PD 24 weeks after last core assessment, found median PFS remaining consistent: 30.8 months (95% CI: 30.0, 31.3). Median time to further PD after placebo-to-lanreotide switch (n=32) was 14.0 months (10.1; not reached). This OLE study suggests long-term treatment with lanreotide Autogel 120 mg maintained favourable safety/tolerability. CLARINET OLE data also provide new evidence of lanreotide anti-tumour benefits in indolent and progressive pancreatic/intestinal NETs.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

01HumanNon-randomized trialEfficacy outcome
In lanreotide-treated NET patients, median progression-free survival from core randomization was 32.8 months (95% CI 30.9 to 68.0).
In plain wordsMedian time without tumor progression was 32.8 months in lanreotide-treated patients.
Peptide
Lanreotide
Outcome
Not applicableMedian progression-free survival
Study
n = 101
Outcome group
Tumor growth · Cancer
Studied dose
120 mgAs given in this study (human).
Measurements
Median progression-free survival
32.8 months
lanreotide, core randomisation to progression
95% CI
30.9 to 68 months
median progression-free survival
Source sentences
Summary
Median lanreotide PFS (core study randomisation to PD in core/OLE; n=101) was 32.8 months (95% CI: 30.9, 68.0).
2 context sentences(design, population, supporting numbers)
Summary · context
Patients with metastatic grade 1/2 (Ki-67 ≤ 10%) non-functioning NET and documented baseline tumour-progression status received lanreotide Autogel 120 mg (n = 101) or placebo (n = 103) for 96 weeks or until death/progressive disease (PD) in CLARINET study.
Summary · context
Patients with stable disease (SD) at core study end (lanreotide/placebo) or PD (placebo only) continued or switched to lanreotide in the OLE.
Show in the study text Report a problemFND-2674312006
02HumanNon-randomized trialEfficacy outcome
In lanreotide-treated NET patients, sensitivity analysis gave median progression-free survival of 30.8 months (95% CI 30.0 to 31.3).
In plain wordsA sensitivity analysis estimated median time without progression at 30.8 months in lanreotide-treated patients.
Peptide
Lanreotide
Outcome
Not applicableSensitivity analysis progression-free survival
Study
n = 101
Outcome group
Tumor growth · Cancer
Studied dose
120 mgAs given in this study (human).
Measurements
Median progression-free survival, sensitivity analysis
30.8 months
lanreotide, assuming 13 patients progressed 24 weeks after last core assessment
95% CI
30 to 31.3 months
sensitivity analysis median progression-free survival
Source sentences
Summary
A sensitivity analysis, addressing potential selection bias by assuming that patients with SD on lanreotide in the core study and not entering the OLE (n=13) had PD 24 weeks after last core assessment, found median PFS remaining consistent: 30.8 months (95% CI: 30.0, 31.3).
2 context sentences(design, population, supporting numbers)
Summary · context
Patients with metastatic grade 1/2 (Ki-67 ≤ 10%) non-functioning NET and documented baseline tumour-progression status received lanreotide Autogel 120 mg (n = 101) or placebo (n = 103) for 96 weeks or until death/progressive disease (PD) in CLARINET study.
Summary · context
Patients with stable disease (SD) at core study end (lanreotide/placebo) or PD (placebo only) continued or switched to lanreotide in the OLE.
Show in the study text Report a problemFND-2674312007
03HumanNon-randomized trialSafety outcome
In NET patients switching from placebo to lanreotide, adverse event rates were similar between extension and core studies, except that more diarrhea was considered treatment-related in the extension.
In plain wordsAdverse event rates after switching to lanreotide were similar to those during prior placebo, except more diarrhea was considered treatment-related.
Peptide
Lanreotide
Outcome
Direction not reportedAdverse events after placebo-to-lanreotide switch
Study
n = 47
Comparator
Core study placebo phase
Outcome group
Adverse events · Whole body
Studied dose
120 mgAs given in this study (human).
Source sentences
Summary
Placebo-to-lanreotide switch patients reported similar AE rates in OLE and core studies, except more diarrhoea was considered treatment-related in OLE (overall diarrhoea unchanged).
2 context sentences(design, population, supporting numbers)
Summary · context
Patients with metastatic grade 1/2 (Ki-67 ≤ 10%) non-functioning NET and documented baseline tumour-progression status received lanreotide Autogel 120 mg (n = 101) or placebo (n = 103) for 96 weeks or until death/progressive disease (PD) in CLARINET study.
Summary · context
Patients with stable disease (SD) at core study end (lanreotide/placebo) or PD (placebo only) continued or switched to lanreotide in the OLE.
Show in the study text Report a problemFND-2674312003
04HumanNon-randomized trialSafety outcome
In NET patients switching to lanreotide, more diarrhea was considered treatment-related in the extension than in the core study.
In plain wordsMore diarrhea was considered treatment-related after switching to lanreotide than during prior placebo treatment.
Peptide
Lanreotide
Outcome
IncreaseTreatment-related diarrhea after switch
Study
n = 47
Comparator
Core study placebo phase
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
120 mgAs given in this study (human).
Source sentences
Summary
Placebo-to-lanreotide switch patients reported similar AE rates in OLE and core studies, except more diarrhoea was considered treatment-related in OLE (overall diarrhoea unchanged).
2 context sentences(design, population, supporting numbers)
Summary · context
Patients with metastatic grade 1/2 (Ki-67 ≤ 10%) non-functioning NET and documented baseline tumour-progression status received lanreotide Autogel 120 mg (n = 101) or placebo (n = 103) for 96 weeks or until death/progressive disease (PD) in CLARINET study.
Summary · context
Patients with stable disease (SD) at core study end (lanreotide/placebo) or PD (placebo only) continued or switched to lanreotide in the OLE.
Show in the study text Report a problemFND-2674312004
05HumanNon-randomized trialSafety outcome
In NET patients switching to lanreotide, overall diarrhea was unchanged between extension and core studies.
In plain wordsOverall diarrhea after switching to lanreotide was unchanged compared with prior placebo treatment.
Peptide
Lanreotide
Outcome
No significant changeOverall diarrhea after switch
Study
n = 47
Comparator
Core study placebo phase
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
120 mgAs given in this study (human).
Source sentences
Summary
Placebo-to-lanreotide switch patients reported similar AE rates in OLE and core studies, except more diarrhoea was considered treatment-related in OLE (overall diarrhoea unchanged).
2 context sentences(design, population, supporting numbers)
Summary · context
Patients with metastatic grade 1/2 (Ki-67 ≤ 10%) non-functioning NET and documented baseline tumour-progression status received lanreotide Autogel 120 mg (n = 101) or placebo (n = 103) for 96 weeks or until death/progressive disease (PD) in CLARINET study.
Summary · context
Patients with stable disease (SD) at core study end (lanreotide/placebo) or PD (placebo only) continued or switched to lanreotide in the OLE.
Show in the study text Report a problemFND-2674312005
06HumanNon-randomized trialSafety outcome
In NET patients continuing lanreotide, all adverse events were less frequent during the extension than during the core study.
In plain wordsPatients continuing lanreotide reported fewer adverse events during the extension than during the core study.
Peptide
Lanreotide
Outcome
DecreaseAll adverse events during continued treatment
Study
n = 41
Comparator
Core study lanreotide phase
Outcome group
Adverse events · Whole body
Studied dose
120 mgAs given in this study (human).
Source sentences
Summary
Patients continuing lanreotide reported fewer adverse events (AEs) (all and treatment-related) during OLE than core study.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients with metastatic grade 1/2 (Ki-67 ≤ 10%) non-functioning NET and documented baseline tumour-progression status received lanreotide Autogel 120 mg (n = 101) or placebo (n = 103) for 96 weeks or until death/progressive disease (PD) in CLARINET study.
Summary · context
Patients with stable disease (SD) at core study end (lanreotide/placebo) or PD (placebo only) continued or switched to lanreotide in the OLE.
Show in the study text Report a problemFND-2674312001
07HumanNon-randomized trialSafety outcome
In NET patients continuing lanreotide, treatment-related adverse events were less frequent during the extension than during the core study.
In plain wordsPatients continuing lanreotide reported fewer treatment-related adverse events during the extension than during the core study.
Peptide
Lanreotide
Outcome
DecreaseTreatment-related adverse events during continued treatment
Study
n = 41
Comparator
Core study lanreotide phase
Outcome group
Adverse events · Whole body
Studied dose
120 mgAs given in this study (human).
Source sentences
Summary
Patients continuing lanreotide reported fewer adverse events (AEs) (all and treatment-related) during OLE than core study.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients with metastatic grade 1/2 (Ki-67 ≤ 10%) non-functioning NET and documented baseline tumour-progression status received lanreotide Autogel 120 mg (n = 101) or placebo (n = 103) for 96 weeks or until death/progressive disease (PD) in CLARINET study.
Summary · context
Patients with stable disease (SD) at core study end (lanreotide/placebo) or PD (placebo only) continued or switched to lanreotide in the OLE.
Show in the study text Report a problemFND-2674312002
08HumanNon-randomized trialEfficacy outcome
In NET patients switching from placebo to lanreotide, median time to further progression was 14.0 months (10.1; not reached).
In plain wordsAfter switching to lanreotide, median time to further tumor progression was 14.0 months.
Peptide
Lanreotide
Outcome
Not applicableTime to further progression after switch
Study
n = 32
Outcome group
Tumor growth · Cancer
Studied dose
120 mgAs given in this study (human).
Measurements
Median time to further progression
14 months
after placebo-to-lanreotide switch
Reported interval lower bound
10.1 months
upper bound not reached; interval type not stated in the abstract
Source sentences
Summary
Median time to further PD after placebo-to-lanreotide switch (n=32) was 14.0 months (10.1; not reached).
2 context sentences(design, population, supporting numbers)
Summary · context
Patients with metastatic grade 1/2 (Ki-67 ≤ 10%) non-functioning NET and documented baseline tumour-progression status received lanreotide Autogel 120 mg (n = 101) or placebo (n = 103) for 96 weeks or until death/progressive disease (PD) in CLARINET study.
Summary · context
Patients with stable disease (SD) at core study end (lanreotide/placebo) or PD (placebo only) continued or switched to lanreotide in the OLE.
Show in the study text Report a problemFND-2674312008

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT00842348

Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero- Pancreatic Endocrine Tumour

Ipsenn = 89Feb 2009 to Dec 2015

Non Functioning Entero-pancreatic Endocrine Tumour

Trial page ClinicalTrials.govUpdated 12 Oct 2022

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:36 UTC
First added · source update from Europe PMC

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