TerminatedNCT02365584QoL in IMBOUpdated Nov 22, 2019Results posted

Quality of Life in Patients With Inoperable Malignant Bowel Obstruction

A Phase 2 interventional study of lanreotide (Autogel formulation) in Intestinal Obstruction, sponsored by Ipsen. Terminated at 13 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-22.

Sponsored by Ipsen · Phase 2, Interventional, and Supportive care

Why this study was terminated

The study was terminated early due to insufficient recruitment.

Phase: Phase 2
Study type: Interventional
Enrollment: 43
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

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.

Conditions studied

Intestinal Obstruction

Browse trials for

Intestinal Obstruction 160

In context

Intestinal Obstruction

160 studies on the registry are indexed under Intestinal Obstruction; 27 are open to participants now.

This study's enrollment of 43 is below the median of 80 across 80 interventional studies indexed under Intestinal Obstruction.

Browse Intestinal Obstruction studies →

Lead sponsor

Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 2
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 43 participants (actual)

Study arms

Experimental
Standard care and Lanreotide Autogel
Standard care according to site clinical practice and Lanreotide Autogel 120 mg by deep subcutaneous route, at the maximal scheduled standard dose of 120 mg/28 days, just for 1 administration.
Drug: lanreotide (Autogel formulation)
No intervention
Standard care
Standard care according to site clinical practice.

Interventions

Druglanreotide (Autogel formulation)
Lanreotide Autogel 120 mg by deep subcutaneous route, at the maximal scheduled standard dose of 120 mg/28 days, just for 1 administration.

What researchers measure

Primary outcomes

Least Squares (LS) Mean Area Under Curve (AUC) of Edmonton Symptom Assessment System (ESAS) Total Scores Collected for the First 7 Days; Full Analysis Set (FAS)
Quality of Life was assessed using ESAS, evaluating 9 common symptoms in cancer patients: pain, activity, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath. Symptom severity is rated 0-10 on a numerical scale (0=symptom absent; 10=worst severity). ESAS total score is sum of the 9 items (min score=0, max score=90). Low scores indicate good quality of life; high scores indicate strong discomfort. Questionnaire assessments by the patient or by nurse/caregiver in case of patient's physical inability. AUC is area under the line which joins the points defined by plotting ESAS total score on vertical axis and time values on horizontal axis, computed using trapezoidal rule. Primary endpoint was analysed using the FAS. LS mean AUC of ESAS total scores during first 7 days is presented.
Time frame: Baseline (Day 1, before randomisation), Days 2, 3, 4, 5, 6 and 7.

Secondary outcomes

Mean Change From Baseline in ESAS Total Score; FAS
Quality of Life was assessed using ESAS, evaluating 9 common symptoms in cancer patients: pain, activity, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath. Symptom severity is rated 0-10 on a numerical scale (0=symptom absent; 10=worst severity). ESAS total score is sum of the 9 items (min score=0, max score=90). Low scores indicate good quality of life; high scores indicate strong discomfort. Questionnaire assessments by the patient or by nurse/caregiver in case of patient's physical inability. Secondary endpoints were analysed using the ITT population but to permit following the FAS which was used for primary endpoint analysis, ESAS total score results are reported for both the ITT and the FAS. Mean change from baseline of ESAS total score at Days 7, 14 and 28 is presented here for the FAS; a positive change indicates a worsening condition.
Time frame: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
Mean Change From Baseline in ESAS Total Score; ITT Population
Quality of Life was assessed using ESAS, evaluating 9 common symptoms in cancer patients: pain, activity, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath. Symptom severity is rated 0-10 on a numerical scale (0=symptom absent; 10=worst severity). ESAS total score is sum of the 9 items (min score=0, max score=90). Low scores indicate good quality of life; high scores indicate strong discomfort. Questionnaire assessments by the patient or by nurse/caregiver in case of patient's physical inability. Secondary endpoints were analysed using the ITT population but to permit following the FAS which was used for primary endpoint analysis, ESAS total score results are reported for both the ITT and the FAS. Mean change from baseline of ESAS total score at Days 7, 14 and 28 is presented here for the ITT population; a positive change indicates a worsening condition.
Time frame: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population
Quality of Life was assessed using ESAS, evaluating 9 common symptoms in cancer patients: pain, activity, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath. Symptom severity is rated 0-10 on a numerical scale (0=symptom absent; 10=worst severity). Low scores indicate good quality of life; high scores indicate strong discomfort. Questionnaire assessments by the patient or by nurse/caregiver in case of patient's physical inability. Mean change from baseline of each individual ESAS item score at Days 7, 14 and 28 is presented; a positive change indicates a worsening condition.
Time frame: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
Mean Change From Baseline in Performing General Activity (Karnofsky Performance Status [KPS]); ITT Population
The KPS allows patients to be classified as to their functional impairment and was used to assess general activity. KPS scores range from 0 (dead) to 100 (normal/no disease) and are classified as 0-40 = unable to care for self; 50-70 = unable to work; 80-100 = able to work. The lower the KPS score, the worse the survival for most serious illnesses. Scores were recorded on the patient's medical file at each study visit (Days 1, 7, 14 and 28). Mean change from baseline of KPS score at Days 7, 14 and 28 is presented for the ITT population (all randomised patients); a negative change indicates a worsening condition.
Time frame: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
Mean Change From Baseline in Daily Intensity of Abdominal Pain Score (Visual Analogue Scale [VAS]); ITT Population
Abdominal pain was assessed using the VAS numeric pain distress scale which is a 100-millimetre (10-centimetre) scoring scale on which patients mark their perceived level of pain. Scores range from 0 to 100 where 0=no pain and 100=unbearable pain. Higher scores indicate a worse outcome. Scores were recorded on the Patient Diary daily until the end of study (Day 28), by the patient or filled in by the nurse/caregiver in case of patient's physical inability. Mean change from baseline of VAS for abdominal pain at Days 7, 14 and 28 is presented for the ITT population; a positive change indicates a worsening condition.
Time frame: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
Number of Patients Experiencing ≤ 2 Vomiting Episodes/Day During at Least 3 Consecutive Days, in Patients Without NGT
Vomiting episodes and NGT presence were recorded on the Patient Diary daily until the end of study (Day 28), by the patient or filled in by the nurse/caregiver in case of patient's physical inability. Number of patients experiencing ≤ 2 vomiting episodes/day during at least 3 consecutive days, in patients without NGT, is presented.
Time frame: From Baseline (Day 1, before randomisation) to Days 7, 14 and 28.
Mean Daily NGT Secretion Volume, in Patients With a NGT
NGT presence and related secretion volume were recorded on the Patient Diary daily until the end of study (Day 28), by the patient or filled in by the nurse/caregiver in case of patient's physical inability. Mean daily secretion volumes, in patients with NGT, is presented.
Time frame: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
Mean Change From Baseline in Number of Daily Vomiting Episodes; ITT Population
Vomiting episodes were recorded on the Patient Diary daily until the end of study (Day 28), by the patient or filled in by the nurse/caregiver in case of patient's physical inability. Mean change from baseline in number of daily vomiting episodes is presented for the ITT population.
Time frame: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
Assessment of Passage of Stools; ITT Population
Passage of stools assessments (Yes/No) were recorded on the Patient Diary daily until the end of study (Day 28), by the patient or filled in by the nurse/caregiver in case of patient's physical inability.
Time frame: From Baseline (Day 1, before randomisation) to Day 28.

Results

Posted Oct 1, 2019

Limitations and caveats

The study was terminated early due to insufficient recruitment. As a consequence, the results of the analyses should be interpreted cautiously and no conclusions should be made.

Participant flow

Recruitment to this prospective, randomised, parallel arm, open-label study began on 14 Jan 2015. Patients with a documented diagnosis of inoperable malignant bowel obstruction who had a nasogastric tube (NGT) or presented with ≥ 3 vomiting episodes/day in the last consecutive 48 hours at time of enrolment were recruited to 14 centres in Italy.

Participant flow — Overall Study
Milestone	Standard Care	Standard Care + Lanreotide Autogel
Started	21	22
Completed	9	8
Not completed	12	14
Withdrew: Adverse event	2	2
Withdrew: Withdrawal by subject	1	0
Withdrew: Disease progression	9	12

Outcome measures

PrimaryLeast Squares (LS) Mean Area Under Curve (AUC) of Edmonton Symptom Assessment System (ESAS) Total Scores Collected for the First 7 Days; Full Analysis Set (FAS)

Quality of Life was assessed using ESAS, evaluating 9 common symptoms in cancer patients: pain, activity, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath. Symptom severity is rated 0-10 on a numerical scale (0=symptom absent; 10=worst severity). ESAS total score is sum of the 9 items (min score=0, max score=90). Low scores indicate good quality of life; high scores indicate strong discomfort. Questionnaire assessments by the patient or by nurse/caregiver in case of patient's physical inability. AUC is area under the line which joins the points defined by plotting ESAS total score on vertical axis and time values on horizontal axis, computed using trapezoidal rule. Primary endpoint was analysed using the FAS. LS mean AUC of ESAS total scores during first 7 days is presented.

Time frame:: Baseline (Day 1, before randomisation), Days 2, 3, 4, 5, 6 and 7.
Reported as:: Least squares mean · Scores on a scale x time (day)

Least Squares (LS) Mean Area Under Curve (AUC) of Edmonton Symptom Assessment System (ESAS) Total Scores Collected for the First 7 Days; Full Analysis Set (FAS)
Scores on a scale x time (day)	Standard Care	Standard Care + Lanreotide Autogel
Least Squares (LS) Mean Area Under Curve (AUC) of Edmonton Symptom Assessment System (ESAS) Total Scores Collected for the First 7 Days; Full Analysis Set (FAS)	179 ± 12.4	190 ± 12.4

Statistical analysis

Standard Care vs Standard Care + Lanreotide Autogel · ANCOVA · p = =0.5396 · Adjusted ls mean difference: -11 · 95% CI -47 to 25

SecondaryMean Change From Baseline in ESAS Total Score; FAS

Quality of Life was assessed using ESAS, evaluating 9 common symptoms in cancer patients: pain, activity, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath. Symptom severity is rated 0-10 on a numerical scale (0=symptom absent; 10=worst severity). ESAS total score is sum of the 9 items (min score=0, max score=90). Low scores indicate good quality of life; high scores indicate strong discomfort. Questionnaire assessments by the patient or by nurse/caregiver in case of patient's physical inability. Secondary endpoints were analysed using the ITT population but to permit following the FAS which was used for primary endpoint analysis, ESAS total score results are reported for both the ITT and the FAS. Mean change from baseline of ESAS total score at Days 7, 14 and 28 is presented here for the FAS; a positive change indicates a worsening condition.

Time frame:: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
Reported as:: Mean · Scores on a scale

Mean Change From Baseline in ESAS Total Score; FAS
Scores on a scale	Standard Care	Standard Care + Lanreotide Autogel
Change at Day 7	-5.1 ± 15.7	1.9 ± 18.4
Change at Day 14	-1.3 ± 21.4	-7.3 ± 16.7
Change at Day 28	-6.8 ± 15.2	-10.3 ± 16.7

SecondaryMean Change From Baseline in ESAS Total Score; ITT Population

Quality of Life was assessed using ESAS, evaluating 9 common symptoms in cancer patients: pain, activity, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath. Symptom severity is rated 0-10 on a numerical scale (0=symptom absent; 10=worst severity). ESAS total score is sum of the 9 items (min score=0, max score=90). Low scores indicate good quality of life; high scores indicate strong discomfort. Questionnaire assessments by the patient or by nurse/caregiver in case of patient's physical inability. Secondary endpoints were analysed using the ITT population but to permit following the FAS which was used for primary endpoint analysis, ESAS total score results are reported for both the ITT and the FAS. Mean change from baseline of ESAS total score at Days 7, 14 and 28 is presented here for the ITT population; a positive change indicates a worsening condition.

Time frame:: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
Reported as:: Mean · Scores on a scale

Mean Change From Baseline in ESAS Total Score; ITT Population
Scores on a scale	Standard Care	Standard Care + Lanreotide Autogel
Change at Day 7	-5.1 ± 15.7	1.5 ± 18.1
Change at Day 14	-1.3 ± 21.4	-7.3 ± 16.7
Change at Day 28	-6.8 ± 15.2	-10.3 ± 16.7

SecondaryMean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population

Time frame:: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
Reported as:: Mean · Scores on a scale

Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population
Scores on a scale	Standard Care	Standard Care + Lanreotide Autogel
Change at Day 7: Pain	-1.8 ± 3.6	0.1 ± 3.4
Change at Day 14: Pain	-1.3 ± 3.6	-1.9 ± 2.9
Change at Day 28: Pain	-3.0 ± 3.1	-1.3 ± 4.2
Change at Day 7: Activity	-0.3 ± 2.6	0.7 ± 2.6
Change at Day 14: Activity	-0.3 ± 3.3	-0.7 ± 3.0
Change at Day 28: Activity	-1.4 ± 2.8	-0.3 ± 3.2
Change at Day 7: Nausea	0.5 ± 3.2	0.9 ± 3.2
Change at Day 14: Nausea	0.1 ± 3.8	0.5 ± 4.1
Change at Day 28: Nausea	-0.6 ± 4.6	0.0 ± 3.9
Change at Day 7: Depression	-1.8 ± 3.5	-1.1 ± 3.7
Change at Day 14 Depression	-1.9 ± 3.5	-2.4 ± 3.2
Change at Day 28: Depression	-2.6 ± 1.9	-3.7 ± 4.0
Change at Day 7: Anxiety	0.0 ± 2.7	-0.2 ± 3.2
Change at Day 14: Anxiety	0.4 ± 3.3	-2.7 ± 3.8
Change at Day 28: Anxiety	-1.1 ± 1.9	-1.5 ± 1.0
Change at Day 7: Drowsiness	-0.7 ± 2.7	0.4 ± 3.1
Change at Day 14: Drowsiness	-0.1 ± 3.5	-0.6 ± 2.6
Change at Day 28: Drowsiness	-1.9 ± 3.1	-1.5 ± 1.5
Change at Day 7: Appetite	-0.2 ± 3.1	0.5 ± 3.2
Change at Day 14: Appetite	0.9 ± 3.0	0.4 ± 3.9
Change at Day 28: Appetite	0.4 ± 3.1	-2.0 ± 2.3
Change at Day 7: Well-being	-0.8 ± 2.6	-0.4 ± 3.1
Change at Day 14: Well-being	0.4 ± 2.5	-0.5 ± 4.3
Change at Day 28: Well-being	0.4 ± 2.4	-2.3 ± 2.9
Change at Day 7: Shortness of breath	-0.1 ± 2.3	0.7 ± 2.6
Change at Day 14: Shortness of breath	0.6 ± 3.4	0.7 ± 2.9
Change at Day 28: Shortness of breath	-0.4 ± 2.0	-0.2 ± 3.8

SecondaryMean Change From Baseline in Performing General Activity (Karnofsky Performance Status [KPS]); ITT Population

The KPS allows patients to be classified as to their functional impairment and was used to assess general activity. KPS scores range from 0 (dead) to 100 (normal/no disease) and are classified as 0-40 = unable to care for self; 50-70 = unable to work; 80-100 = able to work. The lower the KPS score, the worse the survival for most serious illnesses. Scores were recorded on the patient's medical file at each study visit (Days 1, 7, 14 and 28). Mean change from baseline of KPS score at Days 7, 14 and 28 is presented for the ITT population (all randomised patients); a negative change indicates a worsening condition.

Time frame:: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
Reported as:: Mean · Scores on a scale

Mean Change From Baseline in Performing General Activity (Karnofsky Performance Status [KPS]); ITT Population
Scores on a scale	Standard Care	Standard Care + Lanreotide Autogel
Change at Day 7	-2.8 ± 12.3	-3.7 ± 6.8
Change at Day 14	-5.6 ± 11.5	-5.4 ± 12.7
Change at Day 28	-5.0 ± 16.0	-7.1 ± 20.6

SecondaryMean Change From Baseline in Daily Intensity of Abdominal Pain Score (Visual Analogue Scale [VAS]); ITT Population

Abdominal pain was assessed using the VAS numeric pain distress scale which is a 100-millimetre (10-centimetre) scoring scale on which patients mark their perceived level of pain. Scores range from 0 to 100 where 0=no pain and 100=unbearable pain. Higher scores indicate a worse outcome. Scores were recorded on the Patient Diary daily until the end of study (Day 28), by the patient or filled in by the nurse/caregiver in case of patient's physical inability. Mean change from baseline of VAS for abdominal pain at Days 7, 14 and 28 is presented for the ITT population; a positive change indicates a worsening condition.

Time frame:: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
Reported as:: Mean · Scores on a scale

Mean Change From Baseline in Daily Intensity of Abdominal Pain Score (Visual Analogue Scale [VAS]); ITT Population
Scores on a scale	Standard Care	Standard Care + Lanreotide Autogel
Change at Day 7	-22.0 ± 32.5	-9.6 ± 30.8
Change at Day 14	-15.6 ± 34.9	-27.7 ± 28.8
Change at Day 28	-32.0 ± 31.5	-17.0 ± 34.9

SecondaryNumber of Patients Experiencing ≤ 2 Vomiting Episodes/Day During at Least 3 Consecutive Days, in Patients Without NGT

Vomiting episodes and NGT presence were recorded on the Patient Diary daily until the end of study (Day 28), by the patient or filled in by the nurse/caregiver in case of patient's physical inability. Number of patients experiencing ≤ 2 vomiting episodes/day during at least 3 consecutive days, in patients without NGT, is presented.

Time frame:: From Baseline (Day 1, before randomisation) to Days 7, 14 and 28.
Reported as:: Count of participants · Participants

Number of Patients Experiencing ≤ 2 Vomiting Episodes/Day During at Least 3 Consecutive Days, in Patients Without NGT
Participants	Standard Care	Standard Care + Lanreotide Autogel
From Day 1 to Day 7	5	4
From Day 1 to Day 14	4	4
From Day 1 to Day 28	4	4

SecondaryMean Daily NGT Secretion Volume, in Patients With a NGT

NGT presence and related secretion volume were recorded on the Patient Diary daily until the end of study (Day 28), by the patient or filled in by the nurse/caregiver in case of patient's physical inability. Mean daily secretion volumes, in patients with NGT, is presented.

Time frame:: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
Reported as:: Mean · millilitres

Mean Daily NGT Secretion Volume, in Patients With a NGT
millilitres	Standard Care	Standard Care + Lanreotide Autogel
Baseline	200.0 ± NA	700.0 ± 141.4
Day 7	4875.0 ± 4023.6	1025.0 ± 813.2
Day 14	12675.0 ± 2863.8	7090.8 ± 2433.9
Day 28	27501.0 ± 27081.8	18301.4 ± 11657.9

SecondaryMean Change From Baseline in Number of Daily Vomiting Episodes; ITT Population

Vomiting episodes were recorded on the Patient Diary daily until the end of study (Day 28), by the patient or filled in by the nurse/caregiver in case of patient's physical inability. Mean change from baseline in number of daily vomiting episodes is presented for the ITT population.

Time frame:: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
Reported as:: Mean · Episodes (daily)

Mean Change From Baseline in Number of Daily Vomiting Episodes; ITT Population
Episodes (daily)	Standard Care	Standard Care + Lanreotide Autogel
Change at Day 7	5.7 ± 6.2	6.0 ± 9.9
Change at Day 14	10.6 ± 12.7	10.4 ± 15.8
Change at Day 28	16.5 ± 19.9	14.1 ± 20.2

SecondaryAssessment of Passage of Stools; ITT Population

Passage of stools assessments (Yes/No) were recorded on the Patient Diary daily until the end of study (Day 28), by the patient or filled in by the nurse/caregiver in case of patient's physical inability.

Time frame:: From Baseline (Day 1, before randomisation) to Day 28.
Reported as:: Count of participants · Participants

Assessment of Passage of Stools; ITT Population
Participants	Standard Care	Standard Care + Lanreotide Autogel
Day 1 — Yes	2	2
Day 1 — No	19	20
Day 2 — Yes	6	3
Day 2 — No	13	16
Day 3 — Yes	4	3
Day 3 — No	15	17
Day 4 — Yes	4	2
Day 4 — No	15	18
Day 5 — Yes	6	3
Day 5 — No	13	17
Day 6 — Yes	4	2
Day 6 — No	15	17
Day 7 — Yes	3	3
Day 7 — No	16	16
Day 8 — Yes	6	3
Day 8 — No	12	17
Day 9 — Yes	4	5
Day 9 — No	13	14
Day 10 — Yes	3	1
Day 10 — No	13	15
Day 11 — Yes	5	1
Day 11 — No	10	14
Day 12 — Yes	4	1
Day 12 — No	11	11
Day 13 — Yes	3	1
Day 13 — No	12	13
Day 14 — Yes	5	1
Day 14 — No	10	14
Day 15 — Yes	2	2
Day 15 — No	12	10
Day 16 — Yes	3	2
Day 16 — No	11	9
Day 17 — Yes	2	3
Day 17 — No	12	9
Day 18 — Yes	3	2
Day 18 — No	11	8
Day 19 — Yes	3	2
Day 19 — No	8	8
Day 20 — Yes	2	2
Day 20 — No	9	8
Day 21 — Yes	2	2
Day 21 — No	9	7
Day 22 — Yes	2	2
Day 22 — No	9	6
Day 23 — Yes	3	2
Day 23 — No	7	5
Day 24 — Yes	3	2
Day 24 — No	7	6
Day 25 — Yes	2	2
Day 25 — No	7	5
Day 26 — Yes	2	2
Day 26 — No	6	6
Day 27 — Yes	1	2
Day 27 — No	7	4
Day 28 — Yes	3	2
Day 28 — No	4	5

Adverse events

Collected over From baseline (Day 1) until end of study (Day 28).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Standard Care	2/21 (9.5%)	2/21 (9.5%)	5/21 (23.8%)
Standard Care + Lanreotide Autogel	2/22 (9.1%)	2/22 (9.1%)	5/22 (22.7%)

Most frequent serious events

Most frequent serious events
Event	Standard Care	Standard Care + Lanreotide Autogel
Gastrointestinal haemorrhageGastrointestinal disorders	2/21	0/22
Cardiac failureCardiac disorders	0/21	1/22
Myocardial infarctionCardiac disorders	0/21	1/22

Most frequent other events

Most frequent other events
Event	Standard Care	Standard Care + Lanreotide Autogel
HypokalaemiaMetabolism and nutrition disorders	3/21	0/22
PyrexiaGeneral disorders	2/21	1/22
PharyngitisInfections and infestations	0/21	2/22
HypotensionVascular disorders	0/21	2/22

Baseline characteristics

Baseline analysis was performed on the intention to treat (ITT) population which included all randomised patients.

Age, Continuous
Age, Continuous(Years)	Standard Care	Standard Care + Lanreotide Autogel	Total Title
Mean	61.8 ± 9.6	62.8 ± 12.3	62.3 ± 10.9

Sex: Female, Male
Sex: Female, Male(Participants)	Standard Care	Standard Care + Lanreotide Autogel	Total Title
Female	14	19	33
Male	7	3	10

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Standard Care	Standard Care + Lanreotide Autogel	Total Title
Caucasian / White	21	22	43

Study locations

13 sites

Ospedale Sacro Cuore di Gesù, U.O.C. Oncologia Medica
Gallipoli, Lecce 73014, Italy
Ospedali riuniti Ancona- Dipartimento Medicina Interna - Clinica Oncologica
Ancona, 60020, Italy
Centro di Riferimento Oncologico - di Aviano, Dip. di Oncologia Chirurgica- S.O.C. di Chirurgia Oncologica Generale
Aviano, 33081, Italy
Istituto Tumori "Giovanni Paolo II"- Istituto di Ricovero e Cura a Carattere Scientifico, U.O.C. DI ONCOLOGIA MEDICA
Bari, 70124, Italy
Ospedale Sacro Cuore di Gesù - Fatebenefratelli
Benevento, 82100, Italy
Hospice Convento delle Oblate
Firenze, 50139, Italy
Azienda Sanitaria Locale n ° 5 "Spezzino" Ospedale Felettino - Oncologia Via del Forno 4
La Spezia, 19124, Italy
I.R.C.C.S. Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori (I.R.S.T.) srl
Meldola, 47014, Italy
Ospedale San Raffaele IRCCS, Ginecologia oncologica
Milano, 20100, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori - Struttura Complessa di Cure Palliative, Terapia del Dolore e Riabilitazione
Milano, 20133, Italy
Azienda Ospedaliero - Polo Universitario "Luigi Sacco"
Milano, 20157, Italy
A.R.N.A.S. P.O. Civico Benfratelli - Oncologia Medica
Palermo, 90127, Italy
Azienda Ospedaliera Regionale San Carlo- Oncologia Medica
Potenza, 85100, Italy

References and documents

Study documents

Statistical analysis plan · Oct 10, 2018
Study protocol · May 13, 2014

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02365584
Lead sponsor: Ipsen
Responsible party: Sponsor
First posted: Feb 19, 2015
Start date: Jan 2015
Primary completion: Jan 16, 2018
Completion: Jan 16, 2018
Results posted: Oct 1, 2019
Last update: Nov 22, 2019

Study contacts

Ipsen Medical Director

study director · Ipsen

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Intestinal Obstruction→

Other studies from this sponsor

Ipsen

Start the discussion