Back to resultsStudy to Assess Efficacy and Safety of Lanreotide Autogel 120 MG in Treatment of Clinical Symptoms Associated With Inoperable Malignant Intestinal Obstruction (IMIO)
Primary Purpose
Intestinal Obstruction
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Lanreotide Autogel
Sponsored by
About this trial
This is an interventional supportive care trial for Intestinal Obstruction
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
Sites / Locations
- Ste-Elisabeth Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lanreotide Autogel
Arm Description
120mg administered via deep subcutaneous injection at Day 0 and Day 28.
Outcomes
Primary Outcome Measures
Percentage of Responders Before or at Day 7
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.
Secondary Outcome Measures
Percentage of Responders in Phase 1
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.
Median Time Between First Lanreotide Autogel® Injection and Clinical Response in Phase 1
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.
Median Change From Baseline in Quality of Life as Assessed by Edmonton Symptom Assessment System (ESAS) in Phase 1
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.
Median Change From Baseline in General Activity as Assessed by the Karnofsky Performance Status (KPS) Scale in Phase 1
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.
Median Change From Baseline in Number of Daily Episodes of Nausea in Phase 1
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.
Median Change From Baseline in Abdominal Pain Scores Assessed Using Visual Analogue Scale (VAS) in Phase 1
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.
Percentage of Responders Before or at Phase 2 Timepoints
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.
Median Change From Baseline in Quality of Life as Assessed by ESAS in Phase 2
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02275338
Brief Title
Study to Assess Efficacy and Safety of Lanreotide Autogel 120 MG in Treatment of Clinical Symptoms Associated With Inoperable Malignant Intestinal Obstruction
Acronym
IMIO
Official Title
An International, Multicentric, Prospective, Open Label Study to Assess the Efficacy and Safety of Lanreotide Autogel 120 MG Associated to Standard of Care in the Treatment of Clinical Symptoms Associated With Inoperable Malignant Intestinal Obstruction
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 19, 2014 (Actual)
Primary Completion Date
November 9, 2017 (Actual)
Study Completion Date
November 9, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Obstruction
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lanreotide Autogel
Arm Type
Experimental
Arm Description
120mg administered via deep subcutaneous injection at Day 0 and Day 28.
Intervention Type
Drug
Intervention Name(s)
Lanreotide Autogel
Other Intervention Name(s)
Somatuline Autogel
Intervention Description
120mg administered via deep subcutaneous injection at Day 0 and Day 28.
Primary Outcome Measure Information:
Title
Percentage of Responders Before or at Day 7
Description
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.
Time Frame
From Day 0 to Day 7
Secondary Outcome Measure Information:
Title
Percentage of Responders in Phase 1
Description
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.
Time Frame
From Day 0 to Day 28
Title
Median Time Between First Lanreotide Autogel® Injection and Clinical Response in Phase 1
Description
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.
Time Frame
From Day 0 to Day 28
Title
Median Change From Baseline in Quality of Life as Assessed by Edmonton Symptom Assessment System (ESAS) in Phase 1
Description
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.
Time Frame
Days 0, 7, 14 and 28
Title
Median Change From Baseline in General Activity as Assessed by the Karnofsky Performance Status (KPS) Scale in Phase 1
Description
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.
Time Frame
Days 0, 7, 14 and 28
Title
Median Change From Baseline in Number of Daily Episodes of Nausea in Phase 1
Description
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.
Time Frame
Days 0, 7, 14 and 28
Title
Median Change From Baseline in Abdominal Pain Scores Assessed Using Visual Analogue Scale (VAS) in Phase 1
Description
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.
Time Frame
Days 0, 7, 14 and 28
Title
Percentage of Responders Before or at Phase 2 Timepoints
Description
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.
Time Frame
From Day 0 to Day 56
Title
Median Change From Baseline in Quality of Life as Assessed by ESAS in Phase 2
Description
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.
Time Frame
Days 0, 35, 42 and 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
City
Aalst
Country
Belgium
City
Antwerpen
Country
Belgium
City
Brugge
Country
Belgium
Facility Name
Ste-Elisabeth Hospital
City
Brussels
Country
Belgium
City
Chimay
Country
Belgium
City
Gent
Country
Belgium
City
Haine-Saint-Paul
Country
Belgium
City
Libramont
Country
Belgium
City
Liège
Country
Belgium
City
Mons
Country
Belgium
City
Montigny-le-Tilleul
Country
Belgium
City
Oostende
Country
Belgium
City
Ottignies
Country
Belgium
City
Sint - Niklaas
Country
Belgium
City
Tournai
Country
Belgium
City
Verviers
Country
Belgium
City
Yvoir
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
34844770
Citation
Duck L, Demolin G, D'Hondt L, Dopchie C, Hendrickx K, Lannoye B, Bastin F, Lossignol D, Hamdan O, Lybaert W, Vandenhaute V, Regnault B, De Ruyter V, Geboes K. Efficacy and Safety of Lanreotide Autogel in the Treatment of Clinical Symptoms Associated With Inoperable Malignant Intestinal Obstruction: A Prospective Phase II Study. Clin Ther. 2021 Dec;43(12):2136-2145.e2. doi: 10.1016/j.clinthera.2021.10.014. Epub 2021 Nov 26.
Results Reference
derived
Learn more about this trial
Study to Assess Efficacy and Safety of Lanreotide Autogel 120 MG in Treatment of Clinical Symptoms Associated With Inoperable Malignant Intestinal Obstruction
We'll reach out to this number within 24 hrs