Phase 2
N=52
Study to Assess Efficacy and Safety of Lanreotide Autogel 120 MG in Treatment of Clinical Symptoms Associated With Inoperable Malignant Intestinal Obstruction
Intestinal Obstruction
Bottom Line
View on ClinicalTrials.gov: NCT02275338 ↗Enrolled (actual)
52
Serious AEs
55.8%
Results posted
Apr 2019
Primary outcome: Primary: Percentage of Responders Before or at Day 7 — 88.2; 25.7; 46.2 percentage of responders — p=0.0055
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lanreotide Autogel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ipsen
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Responders Before or at Day 7 |
88.2; 25.7; 46.2 | 0.0055 sig |
| SECONDARY Percentage of Responders in Phase 1 |
88.2; 45.7; 59.6; 88.2; 54.3; 65.4 | — |
| SECONDARY Median Time Between First Lanreotide Autogel® Injection and Clinical Response in Phase 1 |
9.00 | — |
| SECONDARY Median Change From Baseline in Quality of Life as Assessed by Edmonton Symptom Assessment System (ESAS) in Phase 1 |
-3.0; -4.5; -2.0; -7.5; -5.5; -5.0 | — |
| SECONDARY Median Change From Baseline in General Activity as Assessed by the Karnofsky Performance Status (KPS) Scale in Phase 1 |
0.0; 0.0; 10.0 | — |
| SECONDARY Median Change From Baseline in Number of Daily Episodes of Nausea in Phase 1 |
-0.17; -1.50; -1.50 | — |
| SECONDARY Median Change From Baseline in Abdominal Pain Scores Assessed Using Visual Analogue Scale (VAS) in Phase 1 |
-3.0; -1.0; 0.0 | — |
| SECONDARY Percentage of Responders Before or at Phase 2 Timepoints |
100; 100; 100; 100; 100; 100 | — |
| SECONDARY Median Change From Baseline in Quality of Life as Assessed by ESAS in Phase 2 |
-4.0; -12.0; -10.5; -13.5; -8.0; -9.0 | — |
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
Data sourced from ClinicalTrials.gov (NCT02275338). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.