Inoperable malignant intestinal obstruction MedDRA version: 19.0 Level: LLT Classification code 10022690 Term: Intestinal obstruction NOS System Organ Class: 100000004856
Conditions
Interventions
Trade Name: Somatuline Autogel injectable 120 mg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: LANREOTIDE
CAS Number: 108736-35-2
Concentration unit: mg milligram(s)
Concentration t
Sponsors
IPSEN NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Written informed consent before any study related procedure 2) Male and female patients age 18 years or older at the time of enrolment 3) Diagnosis of an intestinal obstruction of malignant origin 4) In case of peritoneal carcinomatosis, confirmation by CT or MRI scan within the 3 months preceding the inclusion in the study 5) Confirmed as inoperable after surgical advice 6) Patient with a nasogastric tube OR presenting with 3 or more episodes of vomiting / 24h in the last 48 hours 7) Estimated life expectancy 1 month or more Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1) Operable obstruction or any subobstruction 2) Bowel obstruction due to a non-malignant cause (for example : hypokaliaemia, drug side-effects, renal insufficiency, …) 3) Signs of bowel perforation 4) Prior treatment with somatostatin or any analogue within the previous 60 days 5) A known hypersensitivity to any of the study treatments or related compounds 6) Previous participation in this study 7) Is likely to require treatment during the study with drugs that are not permitted by the study protocol (see Section 9.5). 8) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of lanreotide Autogel lanreotide Autogel 120 mg for the relief of vomiting due to inoperable malignant intestinal obstruction in patients without nasogastric tube AND to assess the efficacy of lanreotide Autogel 120 mg to remove a nasogastric tube without the recurrence of vomiting in patients with an inoperable malignant intestinal obstruction with a nasogastric tube;Secondary Objective: 1) To evaluate the impact on Quality of Life (Edmonton Symptom Assessment System) of lanreotide Autogel 120 mg assessed by both the patient and the caregiver 2) To assess the efficacy of lanreotide Autogel 120 mg for the relief of other clinical symptoms due to inoperable malignant intestinal obstruction : - General activity (Karnofsky score) - Nausea (number of daily episodes) - Pain (Visual analogue scale) - Complete/incomplete obstruction: passage of stools 3) To assess the symptom (nausea and vomiting) improvement delay 4) To assess the pharmacokinetic profile of lanreotide in patients with inoperable malignant intestinal obstruction Safety Objectives : To assess the clinical and biological safety of the study treatment ;Primary end point(s): Percentage of responding patients before or at D7. A responder is defined as a patient experiencing = 2 vomiting episodes/day during at least 3 consecutive days at any time point between the D1 and D7 (for patients without NGT at baseline) or as a patient in whom the NGT has been removed during at least 3 consecutive days at any time point between the D1 and D7 without vomiting recurrence. - Number of daily vomiting episodes recorded on diary cards. - Number of days without vomiting ;Timepoint(s) of evaluation of this end point: Percentage of responding patients before or at D7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoints And Evaluations: Phase 1 : Initial Injection Lanreotide Autogel 120 mg: 1) Percentage of responding patients before or at D14 (same for D28). A responder is defined as a patient experiencing = 2 vomiting episodes/day during at least 3 consecutive days at any time point between the D1 and D14 (D28) or as a patient in whom the NGT has been removed during at least 3 consecutive days at any time point between the D1 and D14 (D28) without vomiting recurrence. - Number of daily vomiting episodes recorded on diary cards. - Number of days without vomiting 2) Time between first injection and clinical response 3) Changes from baseline in Quality of Life (Edmonton Symptom Assessment System) at Day 7, Day 14 and Day 28 assessed by both the patient and the caregiver. 4) Changes in daily intensity and frequency at Day 7, Day 14 and Day 28 compared to baseline in - General activity (Karnofsky score) - Nausea (number of daily episodes) - Pain (Visual analogue scale) - Complete/incomplete obstruction: passage of stools Phase 2 : Second injection Lanreotide Autogel 120 mg : 1) Overall Percentage of patients continuing from Phase I and confirmed as a responder at the end of phase I , showing a continued response at D35, D42 and D56. A responder is defined as a patient experiencing = 2 vomiting episodes/day during at least 3 consecutive days at any time point between the D1 and D35, D42 and D56 or as a patient in whom the NGT has been removed during at least 3 consecutive days at any time point between the D1 and D35, D42 and D56 without vomiting recurrence. - Number of daily vomiting episodes recorded on diary cards. - Number of days without vomiting 2) Changes from baseline in Quality of Life (Edmonton Symptom Assessment System) at Day 35, Day 42 and Day 56 assessed by both the patient and the caregiver. Pharmacokinetic Endpoints and Evaluations: The PK profile of lanreotide Autogel in patients with IMIO using lanr | — |
Countries
Belgium
Contacts
Public ContactVincent De Ruyter
IPSEN NV
Outcome results
None listed