Study to Assess Efficacy and Safety of Lanreotide Autogel 120 MG in Treatment of Clinical Symptoms Associated With Inoperable Malignant Intestinal Obstruction

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.

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.

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.

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 baseline (Day 0) in total symptom distress score, at each of the Phase 1 timepoints is presented and a positive change indicates a worsening condition.

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 (Day 0) at each of the Phase 1 timepoints is presented and a negative change indicates a worsening condition.

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.

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.

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 on diary cards which were completed every day.

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 baseline (Day 0) in total symptom distress score, at each of the Phase 2 timepoints is presented and a positive change indicates a worsening condition.