- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02275338
Study to Assess Efficacy and Safety of Lanreotide Autogel 120 MG in Treatment of Clinical Symptoms Associated With Inoperable Malignant Intestinal Obstruction (IMIO)
April 4, 2019 updated by: Ipsen
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aalst, Belgium
-
Antwerpen, Belgium
-
Brugge, Belgium
-
Brussels, Belgium
- Ste-Elisabeth Hospital
-
Chimay, Belgium
-
Gent, Belgium
-
Haine-Saint-Paul, Belgium
-
Libramont, Belgium
-
Liège, Belgium
-
Mons, Belgium
-
Montigny-le-Tilleul, Belgium
-
Oostende, Belgium
-
Ottignies, Belgium
-
Sint - Niklaas, Belgium
-
Tournai, Belgium
-
Verviers, Belgium
-
Yvoir, Belgium
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lanreotide Autogel
120mg administered via deep subcutaneous injection at Day 0 and Day 28.
|
120mg administered via deep subcutaneous injection at Day 0 and Day 28.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Responders Before or at Day 7
Time Frame: From Day 0 to 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.
|
From Day 0 to Day 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Responders in Phase 1
Time Frame: From Day 0 to Day 28
|
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.
|
From Day 0 to Day 28
|
Median Time Between First Lanreotide Autogel® Injection and Clinical Response in Phase 1
Time Frame: From Day 0 to Day 28
|
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.
|
From Day 0 to Day 28
|
Median Change From Baseline in Quality of Life as Assessed by Edmonton Symptom Assessment System (ESAS) in Phase 1
Time Frame: Days 0, 7, 14 and 28
|
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.
|
Days 0, 7, 14 and 28
|
Median Change From Baseline in General Activity as Assessed by the Karnofsky Performance Status (KPS) Scale in Phase 1
Time Frame: Days 0, 7, 14 and 28
|
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.
|
Days 0, 7, 14 and 28
|
Median Change From Baseline in Number of Daily Episodes of Nausea in Phase 1
Time Frame: Days 0, 7, 14 and 28
|
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. |
Days 0, 7, 14 and 28
|
Median Change From Baseline in Abdominal Pain Scores Assessed Using Visual Analogue Scale (VAS) in Phase 1
Time Frame: Days 0, 7, 14 and 28
|
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.
|
Days 0, 7, 14 and 28
|
Percentage of Responders Before or at Phase 2 Timepoints
Time Frame: From Day 0 to Day 56
|
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.
|
From Day 0 to Day 56
|
Median Change From Baseline in Quality of Life as Assessed by ESAS in Phase 2
Time Frame: Days 0, 35, 42 and 56
|
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.
|
Days 0, 35, 42 and 56
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 19, 2014
Primary Completion (Actual)
November 9, 2017
Study Completion (Actual)
November 9, 2017
Study Registration Dates
First Submitted
October 23, 2014
First Submitted That Met QC Criteria
October 23, 2014
First Posted (Estimate)
October 27, 2014
Study Record Updates
Last Update Posted (Actual)
April 16, 2019
Last Update Submitted That Met QC Criteria
April 4, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A-48-52030-269
- 2013-002174-43 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Intestinal Obstruction
-
Jinling Hospital, ChinaCompletedChronic Intestinal Pseudo ObstructionChina
-
MovetisCompletedChronic Intestinal Pseudo-ObstructionUnited Kingdom
-
University of NottinghamNorthern Care Alliance NHS Foundation Trust; Cambridge University Hospitals... and other collaboratorsRecruiting
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldRecruitingIleus | Small Bowel Obstruction | Intestinal FailureUnited Kingdom
-
Alfasigma S.p.A.Active, not recruitingChronic Intestinal Pseudo-obstructionBelgium, Italy, Spain
-
Roswell Park Cancer InstituteTerminatedMalignant Bowel ObstructionUnited States
-
Yale UniversityTerminatedSmall Bowel ObstructionUnited States
-
Helsinki University Central HospitalUnknownAdhesive Small Bowel ObstructionFinland, Italy
-
Shanghai 10th People's HospitalCompletedFecal Microbiota Transplantation | Intestinal Pseudo-ObstructionChina
-
Danish Small Bowel Obstruction CollaborativeActive, not recruiting
Clinical Trials on Lanreotide Autogel
-
Sheba Medical CenterCompletedCongenital HyperinsulinismIsrael
-
IpsenCompletedNon Functioning Entero-pancreatic Endocrine TumourUnited Kingdom, France, Spain, United States, Belgium, Czechia, Italy, Slovakia, Poland
-
IpsenCompleted
-
Asan Medical CenterSamsung Medical Center; Seoul St. Mary's Hospital; Seoul National University... and other collaboratorsRecruitingNeuroendocrine TumorsKorea, Republic of
-
IpsenCompletedGastroenteropancreatic Neuroendocrine TumorChina
-
IpsenCompletedAcromegalyFrance, Switzerland
-
University Hospital, GhentIpsenCompleted
-
IpsenCompleted
-
IpsenCompleted
-
IpsenCompletedMidgut Neuroendocrine Tumours | Pancreatic TumoursSpain, United Kingdom, Denmark, Belgium, Germany, France, Netherlands, Ireland, Italy, Poland