Study to Assess Efficacy and Safety of Lanreotide Autogel 120 MG in Treatment of Clinical Symptoms Associated With Inoperable Malignant Intestinal Obstruction
CompletedPhase 2Results postedLast updated 16 April 2019
What this trial tests
Phase 2 trial testing Lanreotide Autogel in Intestinal Obstruction in 52 participants. Completed in 9 November 2017.
18 and older, any sex, with Intestinal Obstruction. 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.
Percentage of Responders Before or at Day 7Primary· From Day 0 to Day 7
The primary endpoint assessed the percentage of responding subjects before or at Day 7. A responder was defined as a subject experiencing ≤2 vomiting episodes/day during at least 3 consecutive days at any timepoint between Day 0 and Day 7 (for subjects without NGT at baseline), or as a subject in whom the NGT had been removed during at least 3 consecutive days at any timepoint between Day 0 and Day 7 without vomiting recurrence (for subjects with NGT at baseline), as recorded on diary cards which were completed every day.
Without NGT at Baseline
Group
Value
95% CI
Lanreotide Autogel® 120 mg
88.2
With NGT at Baseline
Group
Value
95% CI
Lanreotide Autogel® 120 mg
25.7
All Subjects
Group
Value
95% CI
Lanreotide Autogel® 120 mg
46.2
Percentage of Responders in Phase 1Secondary· From Day 0 to Day 28
This endpoint assessed the overall percentage of responding subjects at the Phase 1 timepoints of Days 14 and 28. A responder was defined as a subject experiencing ≤ 2 vomiting episodes/day during at least 3 consecutive days at any timepoint between Day 0 and Days 14 or 28 (for subjects without NGT at baseline) or as a subject in whom the NGT has been removed, during at least 3 consecutive days without vomiting recurrence, at any timepoint between Day 0 and Days 14 and 28 (for subjects with NGT at baseline), as recorded on diary cards which were completed every day.
By Day 14: Without NGT at Baseline
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
88.2
By Day 14: With NGT at Baseline
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
45.7
By Day 14: All Subjects
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
59.6
By Day 28: Without NGT at Baseline
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
88.2
By Day 28: With NGT at Baseline
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
54.3
By Day 28: All Subjects
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
65.4
Median Time Between First Lanreotide Autogel® Injection and Clinical Response in Phase 1Secondary· From Day 0 to Day 28
The time for clinical response in Phase 1 (up to Day 28) was defined as the time from inclusion (Day 0) to the date of clinical response. A response was defined as occurrence of ≤ 2 vomiting episodes/day for at least 3 consecutive days at any timepoint between Day 0 and Day 28 (for patients without NGT use at baseline) or the removal of NGT for at least 3 consecutive days at any timepoint between Day 0 and Day 28 without vomiting recurrence (for patients with NGT use at baseline). The Kaplan-Meier estimate of median time to clinical response are presented.
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
9.00
5.00 – 14.00
Median Change From Baseline in Quality of Life as Assessed by Edmonton Symptom Assessment System (ESAS) in Phase 1Secondary· Days 0, 7, 14 and 28
Quality of Life was assessed by both subject and investigator based on the ESAS. The ESAS scale evaluates 9 symptoms common in cancer subjects: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing and shortness of breath. The severity at the time of assessment of each symptom is rated from 0 to 10 on a numerical scale; 0 = symptom is absent and 10 = worst possible severity. Each symptom rating was interpreted independently and a total symptom distress score was calculated for both subject and investigator assessed scores as the sum of the 9 items. Median change from ba
Day 7 - assessed by subject
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
-3.0
-11.0 – 1.0
Day 7 - assessed by investigator
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
-4.5
-14.0 – 3.0
Day 14 - assessed by subject
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
-2.0
-14.0 – 1.0
Day 14 - assessed by investigator
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
-7.5
-17.0 – 2.0
Day 28 - assessed by subject
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
-5.5
-14.0 – -1.0
Day 28 - assessed by investigator
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
-5.0
-14.0 – 5.5
Median Change From Baseline in General Activity as Assessed by the Karnofsky Performance Status (KPS) Scale in Phase 1Secondary· Days 0, 7, 14 and 28
The KPS scale was used to quantify subject's general well-being and activities of daily life. Subjects were classified based on their functional impairment and KPS scores range from 0 (death) to 100 (no evidence of disease). KPS scores are classified as 0-40 = unable to care for self; requires equivalent of institutional or hospital care; disease may be progressing rapidly; 50-70 = unable to work; able to live at home and care for most personal needs; varying amount of assistance needed; 80-100 = able to carry on normal activity and to work; no special care needed. Median change from baseline
At Day 7
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
0.0
0.0 – 10.0
At Day 14
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
0.0
0.0 – 20.0
At Day 28
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
10.0
0.0 – 30.0
Median Change From Baseline in Number of Daily Episodes of Nausea in Phase 1Secondary· Days 0, 7, 14 and 28
The mean number of daily episodes of nausea were calculated as the sum of episodes of nausea reported the last 3 days before the corresponding visit, divided by 3.
The median change from baseline (Day 0) at each of the Phase 1 timepoints is presented and positive change indicates a worsening condition.
At Day 7
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
-0.17
-1.67 – 0.0
At Day 14
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
-1.50
-4.00 – 0.00
At Day 28
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
-1.50
-3.67 – 0.00
Median Change From Baseline in Abdominal Pain Scores Assessed Using Visual Analogue Scale (VAS) in Phase 1Secondary· Days 0, 7, 14 and 28
Abdominal pain was assessed using the VAS numeric pain distress scale. The VAS is a 100-millimetre (10-centimetre) scoring scale on which subjects marked on their perceived level of pain. Score range on VAS is from 0 to 100 where 0 = no pain and 100 = unbearable pain. Median change from baseline (Day 0) at each of the Phase 1 timepoints is presented and a positive change indicates a worsening condition.
At Day 7
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
-3.0
-13.0 – 0.0
At Day 14
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
-1.0
-9.0 – 6.0
At Day 28
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
0.0
-9.0 – 10.0
Percentage of Responders Before or at Phase 2 TimepointsSecondary· From Day 0 to Day 56
This endpoint assessed the overall percentage of subjects continuing from Phase 1 and confirmed as a responder at the end of Phase 1, showing a continued response at Days 35, 42 and 56. A responder was defined as a subject experiencing ≤2 vomiting episodes/day during at least 3 consecutive days at any timepoint between Day 0 and Days 35, 42, 56 (for subjects without NGT at baseline), or as a subject in whom the NGT had been removed during at least 3 consecutive days at any timepoint between Day 0 and Days 35, 42, 56 without vomiting recurrence (for subjects with NGT at baseline), as recorded o
By Day 35: Without NGT at Baseline
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
100
By Day 35: With NGT at Baseline
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
100
By Day 35: All Subjects
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
100
By Day 42: Without NGT at Baseline
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
100
By Day 42: With NGT at Baseline
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
100
By Day 42: All Subjects
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
100
By Day 56: Without NGT at Baseline
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
100
By Day 56: With NGT at Baseline
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
100
Median Change From Baseline in Quality of Life as Assessed by ESAS in Phase 2Secondary· Days 0, 35, 42 and 56
Quality of Life was assessed by both subject and investigator based on the ESAS. The ESAS scale evaluates 9 symptoms common in cancer subjects: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing and shortness of breath. The severity at the time of assessment of each symptom is rated from 0 to 10 on a numerical scale, 0 = symptom is absent and 10 = worst possible severity. Each symptom rating was interpreted independently and a total symptom distress score was calculated for both subject and investigator assessed scores as the sum of the 9 items. Median change from ba
Day 35 - assessed by subject
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
-4.0
-22.0 – 1.0
Day 35 - assessed by investigator
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
-12.0
-18.0 – -2.0
Day 42 - assessed by subject
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
-10.5
-16.0 – 0.0
Day 42 - assessed by investigator
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
-13.5
-19.0 – -3.0
Day 56 - assessed by subject
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
-8.0
-17.0 – -1.0
Day 56 - assessed by investigator
Group
Value
95% CI
Lanreotide Autogel® 120 mg - All Subjects
-9.0
-17.0 – -2.0
Adverse events — posted to ClinicalTrials.gov
Time frame: All cause mortality and Adverse events (AEs) were monitored from the time the subject gave informed consent (Day 0) and throughout the study up to Day 56..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Lanreotide Autogel® 120 mg - All Subjects
Serious: 29/52 (56%)
Deaths: 15/52
Serious adverse events (31 terms)
Reaction
System
Lanreotide Autogel® 120 mg…
Disease progression
General disorders
—
General physical health deterioration
General disorders
—
Intestinal obstruction
Gastrointestinal disorders
—
Vomiting
Gastrointestinal disorders
—
Electrolyte imbalance
Metabolism and nutrition disorders
—
Abdominal pain
Gastrointestinal disorders
—
Ascites
Gastrointestinal disorders
—
Gastrointestinal haemorrhage
Gastrointestinal disorders
—
Large intestine perforation
Gastrointestinal disorders
—
Mesenteric vein thrombosis
Gastrointestinal disorders
—
Nausea
Gastrointestinal disorders
—
Small intestinal obstruction
Gastrointestinal disorders
—
Inflammation
General disorders
—
Multiple organ dysfunction syndrome
General disorders
—
Hepatic failure
Hepatobiliary disorders
—
Abscess intestinal
Infections and infestations
—
Escherichia sepsis
Infections and infestations
—
Pneumonia
Infections and infestations
—
Septic shock
Infections and infestations
—
Urinary tract infection
Infections and infestations
—
Urosepsis
Infections and infestations
—
Liver function test abnormal
Investigations
—
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
To assess the efficacy of Lanreotide Autogel 120 mg for the relief of vomiting due to inoperable malignant intestinal obstruction in patients without nasogastric tube (NGT) and to assess the efficacy of lanreotide Autogel 120 mg on removal of nasogastric tube without the recurrence of vomiting in patients with an inoperable malignant intestinal obstruction with a nasogastric tube.
Publications & conference data
2 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: 16 April 2019
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/NCT02275338.