NCT02275338

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2014

Typical duration for phase_2

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2014

Completed
23 days until next milestone

Study Start

First participant enrolled

November 19, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2017

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

April 1, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

3 years

First QC Date

October 23, 2014

Results QC Date

January 2, 2019

Last Update Submit

April 4, 2019

Conditions

Intestinal Obstruction

Outcome Measures

Primary Outcomes (1)

  • 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.

    From Day 0 to Day 7

Secondary Outcomes (8)

  • Percentage of Responders in Phase 1

    From Day 0 to Day 28

  • Median Time Between First Lanreotide Autogel® Injection and Clinical Response in Phase 1

    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

    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

    Days 0, 7, 14 and 28

  • Median Change From Baseline in Number of Daily Episodes of Nausea in Phase 1

    Days 0, 7, 14 and 28

  • +3 more secondary outcomes

Study Arms (1)

Lanreotide Autogel

EXPERIMENTAL

120mg administered via deep subcutaneous injection at Day 0 and Day 28.

Drug: Lanreotide Autogel

Interventions

Lanreotide AutogelDRUG

120mg administered via deep subcutaneous injection at Day 0 and Day 28.

Also known as: Somatuline Autogel
Lanreotide Autogel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Unknown Facility

Aalst, Belgium

Location

Unknown Facility

Antwerp, Belgium

Location

Unknown Facility

Bruges, Belgium

Location

Ste-Elisabeth Hospital

Brussels, Belgium

Location

Unknown Facility

Chimay, Belgium

Location

Unknown Facility

Ghent, Belgium

Location

Unknown Facility

Haine-Saint-Paul, Belgium

Location

Unknown Facility

Libramont, Belgium

Location

Unknown Facility

Liège, Belgium

Location

Unknown Facility

Mons, Belgium

Location

Unknown Facility

Montigny-le-Tilleul, Belgium

Location

Unknown Facility

Ostend, Belgium

Location

Unknown Facility

Ottignies, Belgium

Location

Unknown Facility

Sint-Niklaas, Belgium

Location

Unknown Facility

Tournai, Belgium

Location

Unknown Facility

Verviers, Belgium

Location

Unknown Facility

Yvoir, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 34844770DERIVED

MeSH Terms

Conditions

Intestinal Obstruction

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Limitations and Caveats

Results from outcome measures regarding change from baseline in quality of life (ESAS scale), general activity (KPS Scale) and daily episodes of nausea should be interpreted with caution due to small sample sizes.

Results Point of Contact

Title
Medical Director
Organization
Ipsen
clinical.trials@ipsen.com
see email

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2014

First Posted

October 27, 2014

Study Start

November 19, 2014

Primary Completion

November 9, 2017

Study Completion

November 9, 2017

Last Updated

April 16, 2019

Results First Posted

April 1, 2019

Record last verified: 2019-04

Locations

BE(17)