Quality of Life in Patients With Inoperable Malignant Bowel Obstruction

A Phase II, Multicentre, Randomized Controlled Study Evaluating The Quality Of Life In Patients With Inoperable Malignant Bowel Obstruction Treated With Lanreotide Autogel 120 mg in Combination With Standard Care vs. Standard Care Alone (QOL IN IMBO STUDY)

The primary objective of the study is to evaluate the impact on quality of life of Lanreotide Autogel 120 mg in combination with standard care, in comparison to the standard care alone, in subjects affected by inoperable malignant bowel obstruction.

Inclusion Criteria:

• Subjects must demonstrate willingness to participate in the study and to be compliant with any protocol procedure.
• Provision of written informed consent prior to any study related procedure.
• Diagnosis of an inoperable malignant bowel obstruction, confirmed by appropriate imaging report.
• In case of peritoneal carcinomatosis, diagnostic confirmation by CT or MRI scan.
• Confirmed as inoperable after medical advice.
• Patient with a nasogastric tube or presenting with 3 or more episodes of vomiting every day in the last consecutive 48 hours.
• Patient life expectancy must be more than 14 days.

Exclusion Criteria:

• Has operable obstruction or any sub-obstruction.
• Has bowel obstruction due to a non-malignant cause; (hypokaliaemia, drug side-effects, renal insufficiency, etc).
• Has signs of bowel perforation.
• Has prior treatment with somatostatin or any analogue within the previous 60 days.
• Has a known hypersensitivity to any of the study treatments or related compounds.
• Is likely to require treatment during the study with somatostatin or any analogue other than the study treatment.
• Is at risk of pregnancy or lactation, or is likely to father a child during the study. Females of childbearing potential must provide a negative pregnancy test at start of study and must be using oral or double barrier contraception. Non childbearing potential is defined as post-menopause for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study.
• Has any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
• 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 or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.