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Study · Non-randomized trial · n = 32 · 2017

7 results

Phase II study of lanreotide autogel in Japanese patients with unresectable or metastatic well-differentiated neuroendocrine tumors.

Ito T, Honma Y, Hijioka S, Kudo A, Fukutomi A, Nozaki A, Kimura Y, Motoi F, Isayama H, Komoto I, Hisamatsu S, Nakajima A, Shimatsu A

Investigational new drugs3 May 2017Cited by 26 (Europe PMC)

PMID28470558 (opens in a new tab)PMCIDPMC5502055 (opens in a new tab)DOI10.1007/s10637-017-0466-8 (opens in a new tab)PepBankPUB-28470558
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Summary

Background Lanreotide is a long-acting somatostatin analog with demonstrated efficacy against enteropancreatic neuroendocrine tumor (NET) in the phase III (CLARINET) study. Materials and Methods In this single-arm study, Japanese patients with grade (G) 1/G2 NET received lanreotide (120 mg/4 weeks) for 48 weeks. Those who completed the study were enrolled in a long-term extension study. The primary endpoint was the clinical benefit rate (CBR) defined as a complete response, partial response (PR), or stable disease (SD) over 24-weeks. Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), safety, and pharmacokinetics. Results Thirty-two patients were recruited at 10 sites. The full analysis set (FAS) comprised 28 patients. Primary tumors were located in pancreas (12 patients), foregut (non-pancreas, lung; 1), midgut (2), hindgut (8), and unknown (5). Four patients had gastrinoma of the functional NET, and 3 had multiple endocrine neoplasia type 1. In the FAS, 39.3% had progressive disease at baseline. The CBR at 24 weeks was 64.3% (95% confidence interval; CI: 44.1-81.4), and median PFS was 36.3 weeks (95% CI: 24.1-53.1). PR was confirmed in 1 patient at 60 weeks during the extension study (ORR: 3.6%). Frequent adverse events related to lanreotide included injection site induration (28.1%), faeces pale (18.8%), flatulence (12.5%), and diabetes mellitus (12.5%). Conclusions The efficacy and safety of lanreotide in this study indicated its usefulness as a treatment option for Japanese NET patients.Trial registrationJapicCTI-132,375, JapicCTI-142,698.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In Japanese NET patients receiving lanreotide, clinical benefit at 24 weeks was 64.3% (95% CI 44.1-81.4).

    In plain wordsIn Japanese patients receiving lanreotide, the clinical benefit rate was 64.3%.

    Peptide
    Lanreotide
    Outcome
    Not applicableClinical benefit rate at 24 weeks
    Study

    n = 28

    Analysis
    Primary
    Outcome group
    Tumor growth · Cancer
    Studied dose
    120 mg every 4 weeks · 48 weeksAs given in this study (human).

    Measurements

    Clinical benefit rate at 24 weeks
    64.3%
    full analysis set
    95% CI
    44.1 to 81.4%
    clinical benefit rate

    Source sentences

    Summary
    The CBR at 24 weeks was 64.3% (95% confidence interval; CI: 44.1-81.4), and median PFS was 36.3 weeks (95% CI: 24.1-53.1).
    1 context sentence
    Summary · context
    Materials and Methods In this single-arm study, Japanese patients with grade (G) 1/G2 NET received lanreotide (120 mg/4 weeks) for 48 weeks.
  2. 02HumanNon-randomized trialSafety outcome

    In Japanese NET patients, lanreotide-related injection site induration occurred in 28.1%.

    In plain wordsInjection site hardening occurred in 28.1% of Japanese NET patients receiving lanreotide.

    Peptide
    Lanreotide
    Outcome
    Not applicableInjection site induration
    Study

    n = 32

    Analysis
    Secondary
    Outcome group
    Adverse events · Skin and wound
    Studied dose
    120 mg every 4 weeks · 48 weeksAs given in this study (human).

    Measurements

    Injection site induration incidence
    28.1%
    lanreotide-related adverse events

    Source sentences

    Summary
    Frequent adverse events related to lanreotide included injection site induration (28.1%), faeces pale (18.8%), flatulence (12.5%), and diabetes mellitus (12.5%).
    1 context sentence
    Summary · context
    Materials and Methods In this single-arm study, Japanese patients with grade (G) 1/G2 NET received lanreotide (120 mg/4 weeks) for 48 weeks.
  3. 03HumanNon-randomized trialSafety outcome

    In Japanese NET patients, lanreotide-related pale feces occurred in 18.8%.

    In plain wordsPale stools occurred in 18.8% of Japanese NET patients receiving lanreotide.

    Peptide
    Lanreotide
    Outcome
    Not applicablePale feces
    Study

    n = 32

    Analysis
    Secondary
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    120 mg every 4 weeks · 48 weeksAs given in this study (human).

    Measurements

    Pale faeces incidence
    18.8%
    lanreotide-related adverse events

    Source sentences

    Summary
    Frequent adverse events related to lanreotide included injection site induration (28.1%), faeces pale (18.8%), flatulence (12.5%), and diabetes mellitus (12.5%).
    1 context sentence
    Summary · context
    Materials and Methods In this single-arm study, Japanese patients with grade (G) 1/G2 NET received lanreotide (120 mg/4 weeks) for 48 weeks.
  4. 04HumanNon-randomized trialSafety outcome

    In Japanese NET patients, lanreotide-related flatulence occurred in 12.5%.

    In plain wordsFlatulence occurred in 12.5% of Japanese NET patients receiving lanreotide.

    Peptide
    Lanreotide
    Outcome
    Not applicableFlatulence
    Study

    n = 32

    Analysis
    Secondary
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    120 mg every 4 weeks · 48 weeksAs given in this study (human).

    Measurements

    Flatulence incidence
    12.5%
    lanreotide-related adverse events

    Source sentences

    Summary
    Frequent adverse events related to lanreotide included injection site induration (28.1%), faeces pale (18.8%), flatulence (12.5%), and diabetes mellitus (12.5%).
    1 context sentence
    Summary · context
    Materials and Methods In this single-arm study, Japanese patients with grade (G) 1/G2 NET received lanreotide (120 mg/4 weeks) for 48 weeks.
  5. 05HumanNon-randomized trialSafety outcome

    In Japanese NET patients, lanreotide-related diabetes mellitus occurred in 12.5%.

    In plain wordsDiabetes occurred in 12.5% of Japanese NET patients receiving lanreotide.

    Peptide
    Lanreotide
    Outcome
    Not applicableDiabetes mellitus
    Study

    n = 32

    Analysis
    Secondary
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    120 mg every 4 weeks · 48 weeksAs given in this study (human).

    Measurements

    Diabetes mellitus incidence
    12.5%
    lanreotide-related adverse events

    Source sentences

    Summary
    Frequent adverse events related to lanreotide included injection site induration (28.1%), faeces pale (18.8%), flatulence (12.5%), and diabetes mellitus (12.5%).
    1 context sentence
    Summary · context
    Materials and Methods In this single-arm study, Japanese patients with grade (G) 1/G2 NET received lanreotide (120 mg/4 weeks) for 48 weeks.
  6. 06HumanNon-randomized trialEfficacy outcome

    In Japanese NET patients receiving lanreotide, median progression-free survival was 36.3 weeks (95% CI 24.1-53.1).

    In plain wordsIn Japanese patients receiving lanreotide, median time without tumor progression was 36.3 weeks.

    Peptide
    Lanreotide
    Outcome
    Not applicableMedian progression-free survival
    Study

    n = 28

    Analysis
    Secondary
    Outcome group
    Tumor growth · Cancer
    Studied dose
    120 mg every 4 weeks · 48 weeksAs given in this study (human).

    Measurements

    Median progression-free survival
    36.3 weeks
    full analysis set
    95% CI
    24.1 to 53.1 weeks
    median progression-free survival

    Source sentences

    Summary
    The CBR at 24 weeks was 64.3% (95% confidence interval; CI: 44.1-81.4), and median PFS was 36.3 weeks (95% CI: 24.1-53.1).
    1 context sentence
    Summary · context
    Materials and Methods In this single-arm study, Japanese patients with grade (G) 1/G2 NET received lanreotide (120 mg/4 weeks) for 48 weeks.
  7. 07HumanNon-randomized trialEfficacy outcome

    In Japanese NET patients receiving lanreotide, one partial response was confirmed at 60 weeks in the extension (objective response rate 3.6%).

    In plain wordsOne patient had a partial tumor response at 60 weeks during the lanreotide extension study.

    Peptide
    Lanreotide
    Outcome
    Not applicablePartial response and objective response rate
    Study

    n = 28

    Analysis
    Secondary
    Outcome group
    Tumor growth · Cancer
    Studied dose
    120 mg every 4 weeksAs given in this study (human).

    Measurements

    Partial responses
    1 patients
    confirmed at 60 weeks during extension study
    Objective response rate
    3.6%
    full analysis set

    Source sentences

    Summary
    PR was confirmed in 1 patient at 60 weeks during the extension study (ORR: 3.6%).
    1 context sentence
    Summary · context
    Materials and Methods In this single-arm study, Japanese patients with grade (G) 1/G2 NET received lanreotide (120 mg/4 weeks) for 48 weeks.

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

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.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:36 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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