Clinical trial NCT02275338: Study to Assess Efficacy and Safety of Lanreotide Autogel 120 MG in Treatment of Clinical Symptoms Associated With Inoperable Malignant Intestinal Obstruction
Official title: An International, Multicentric, Prospective, Open Label Study to Assess the Efficacy and Safety of Lanreotide Autogel 120 MG Associated to Standard of Care in the Treatment of Clinical Symptoms Associated With Inoperable Malignant Intestinal Obstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Intestinal Obstruction
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2014-10-27
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Written informed consent before any study related procedure
* Male and female patients age 18 years or older at time of enrollment
* Diagnosis of intestinal obstruction of malignant origin
* In case of peritoneal carcinomatosis, confirmation by CT or MRI scan within the 3 months preceding the inclusion in the study
* Confirmed as inoperable after surgical advice
* Patient with a nasogastric tube OR presenting with 3 or more episodes of vomiting / 24h in the last 48 hours
* Estimated life expectancy 1 month or more

Exclusion Criteria:

* Operable obstruction or subobstruction
* Bowel obstruction due to a non-malignant cause
* Signs of bowel perforation
* Prior treatment with somatostatin or any other analogue within the previous 60 days
* A known hypersensitivity to any of the study treatments or related compounds
* Previous participation in this study
* Is likely to require treatment during the study with drugs that are not permitted by the study protocol
* Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the subject's safety

Primary outcomes:
measure: Percentage of Responders Before or at Day 7
timeFrame: From Day 0 to Day 7
Secondary outcomes:
measure: Percentage of Responders in Phase 1
timeFrame: From Day 0 to Day 28
measure: Median Time Between First Lanreotide Autogel® Injection and Clinical Response in Phase 1
timeFrame: From Day 0 to Day 28
measure: Median Change From Baseline in Quality of Life as Assessed by Edmonton Symptom Assessment System (ESAS) in Phase 1
timeFrame: Days 0, 7, 14 and 28
measure: Median Change From Baseline in General Activity as Assessed by the Karnofsky Performance Status (KPS) Scale in Phase 1
timeFrame: Days 0, 7, 14 and 28
measure: Median Change From Baseline in Number of Daily Episodes of Nausea in Phase 1
timeFrame: Days 0, 7, 14 and 28
measure: Median Change From Baseline in Abdominal Pain Scores Assessed Using Visual Analogue Scale (VAS) in Phase 1
timeFrame: Days 0, 7, 14 and 28
measure: Percentage of Responders Before or at Phase 2 Timepoints
timeFrame: From Day 0 to Day 56
measure: Median Change From Baseline in Quality of Life as Assessed by ESAS in Phase 2
timeFrame: Days 0, 35, 42 and 56
Other outcomes:
Locations:
city: Aalst
country: Belgium
city: Antwerpen
country: Belgium
city: Brugge
country: Belgium
city: Brussels
country: Belgium
facility: Ste-Elisabeth Hospital
city: Chimay
country: Belgium
city: Gent
country: Belgium
city: Haine-Saint-Paul
country: Belgium
city: Libramont
country: Belgium
city: Liège
country: Belgium
city: Mons
country: Belgium
city: Montigny-le-Tilleul
country: Belgium
city: Oostende
country: Belgium
city: Ottignies
country: Belgium
city: Sint - Niklaas
country: Belgium
city: Tournai
country: Belgium
city: Verviers
country: Belgium
city: Yvoir
country: Belgium
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: Duck L, Demolin G, D'Hondt L, Dopchie C, Hendrickx K, Lannoye B, Bastin F, Lossignol D, Hamdan O, Lybaert W, Vandenhaute V, Regnault B, De Ruyter V, Geboes K. Efficacy and Safety of Lanreotide Autogel in the Treatment of Clinical Symptoms Associated With Inoperable Malignant Intestinal Obstruction: A Prospective Phase II Study. Clin Ther. 2021 Dec;43(12):2136-2145.e2. doi: 10.1016/j.clinthera.2021.10.014. Epub 2021 Nov 26.