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Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)

Primary Purpose

Gastrointestinal Stromal Tumors

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Masitinib
Imatinib
Sponsored by
AB Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Stromal Tumors focused on measuring Gastro-Intestinal Stromal Tumor, GIST, metastatic, non resectable locally advanced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main inclusion criteria include:

  • Histologically proven, metastatic or locally advanced non resectable, or recurrent post-surgery GIST
  • Naïve patient or patient previously treated with imatinib as neoadjuvant/adjuvant who relapsed after imatinib discontinuation
  • c-Kit (CD117) positive tumours detected by immuno-histochemically or PDGFR positive if c-Kit negative

Main exclusion criteria include:

  • Patient previously treated by tyrosine kinase inhibitors except imatinib in case of inclusion criteria
  • Patient treated for a cancer other than GIST within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ
  • Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis

Sites / Locations

  • MD Anderson Cancer Center
  • The Emory Clinic
  • Henry Ford Health System
  • Beth Israel Medical Center
  • Ohio State University
  • Cancer Centers of the Carolinas
  • Medical College of Wisconsin
  • Centre Hospitalier d'Abbeville
  • Institut Sainte Catherine
  • Hôpital Jean Minjoz
  • Institut Bergonié
  • Hôpital Morvan
  • Hôpitalo Henri Mondor
  • Centre Georges François Leclerc
  • Hopital Bocage
  • Centre Hospitalier Victor Jousselin
  • Clinique Pasteur
  • Centre Hospitalier de Gap
  • CHD de Vendée
  • Centre Hsopitalier de La Rochelle
  • Centre Hospitalier Robert Boulin
  • Centre Oscar Lambret
  • Centre Léon Bérard
  • Institut Paoli Calmette
  • Centre Val d'Aurèle
  • Centre René Gauducheau
  • Hôpital de la Source
  • Groupe Hospitalier Diaconesse Croix Saint Simon
  • Hôpital Européen Georges Pompidou
  • Hôpital Bichat Claude Bernard
  • Hôpital Tenon
  • Hôpital Robert Debré
  • Hôpital Charles Nicolle
  • Clinique Armoricaine de Radiologie
  • Centre René Huguenin
  • Institut de Cancérologie de la Loire
  • Hotel Dieu de France
  • Hôpital Saint-Georges
  • Makassed General Hospital Tarik Jadide
  • Rafik Hariri University Hospital
  • Hôpital Saint-Joseph

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Masitinib (7.5)

Masitinib (6.0)

Active Comparator (7.5)

Active Comparator (6.0)

Arm Description

Participants receive masitinib (7.5 mg/kg/day), given orally twice daily.

Participants receive masitinib (6.0 mg/kg/day), given orally twice daily

Participants receive imatinib at 400 or 600 mg per day

Participants receive imatinib at 400 or 600 mg per day

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)
Progression Free Survival is defined as the time from randomization to first documentation of objective tumor progression (date of tumor assessment documenting progressive disease assessed by CT Scan according to RECIST 1.1 and based on central review) or to death due to any cause (whichever comes first).

Secondary Outcome Measures

Overall Survival (OS)
Overall survival is defined as time in months from the randomization date to the date of death due to any cause

Full Information

First Posted
December 19, 2008
Last Updated
January 31, 2023
Sponsor
AB Science
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1. Study Identification

Unique Protocol Identification Number
NCT00812240
Brief Title
Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)
Official Title
A Prospective, Multicenter, Randomized, Open-label, Active-controlled, 2-parallel Group, Phase III Study to Compare Efficacy and Safety of Masitinib at 7.5 mg/kg/Day to Imatinib at 400 or 600 mg in Treatment of Patients With Gastro-intestinal Stromal Tumor in First Line Medical Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision based on portfolio prioritization
Study Start Date
January 2009 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AB Science

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)
Detailed Description
Masitinib is a selective tyrosine kinase inhibitor with potent activity against wild-type c-Kit, the juxta membrane domain of c-Kit, and PDGFR. In addition to its direct inhibitory action against these kinase targets, masitinib is also thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective of this prospective, multicenter, randomized, open-label, active-controlled study is to compare the efficacy and safety of masitinib with respect to imatinib in the first line treatment of gastro-intestinal stromal tumor (GIST). Treatment will be given until disease progression, limiting toxicity or patient consent withdrawal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumors
Keywords
Gastro-Intestinal Stromal Tumor, GIST, metastatic, non resectable locally advanced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
335 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Masitinib (7.5)
Arm Type
Experimental
Arm Description
Participants receive masitinib (7.5 mg/kg/day), given orally twice daily.
Arm Title
Masitinib (6.0)
Arm Type
Experimental
Arm Description
Participants receive masitinib (6.0 mg/kg/day), given orally twice daily
Arm Title
Active Comparator (7.5)
Arm Type
Active Comparator
Arm Description
Participants receive imatinib at 400 or 600 mg per day
Arm Title
Active Comparator (6.0)
Arm Type
Active Comparator
Arm Description
Participants receive imatinib at 400 or 600 mg per day
Intervention Type
Drug
Intervention Name(s)
Masitinib
Other Intervention Name(s)
AB1010
Intervention Type
Drug
Intervention Name(s)
Imatinib
Other Intervention Name(s)
Gleevec
Intervention Description
imatinib 400 mg or 600 mg per day, per os
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
Progression Free Survival is defined as the time from randomization to first documentation of objective tumor progression (date of tumor assessment documenting progressive disease assessed by CT Scan according to RECIST 1.1 and based on central review) or to death due to any cause (whichever comes first).
Time Frame
From day of randomization to disease progression or death, assessed for a maximum of 96 months]
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall survival is defined as time in months from the randomization date to the date of death due to any cause
Time Frame
From day of randomization to death, assessed for a maximum of 96 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main inclusion criteria include: Histologically proven, metastatic or locally advanced non resectable, or recurrent post-surgery GIST Naïve patient or patient previously treated with imatinib as neoadjuvant/adjuvant who relapsed after imatinib discontinuation c-Kit (CD117) positive tumours detected by immuno-histochemically or PDGFR positive if c-Kit negative Main exclusion criteria include: Patient previously treated by tyrosine kinase inhibitors except imatinib in case of inclusion criteria Patient treated for a cancer other than GIST within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine Adenis, MD
Organizational Affiliation
Centre Oscar Lambret, Lille, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
MD Anderson Cancer Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
The Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Cancer Centers of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
290605
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Centre Hospitalier d'Abbeville
City
Abbeville
ZIP/Postal Code
80142
Country
France
Facility Name
Institut Sainte Catherine
City
Avignon
ZIP/Postal Code
84000
Country
France
Facility Name
Hôpital Jean Minjoz
City
Besançon
ZIP/Postal Code
25000
Country
France
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Hôpital Morvan
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Hôpitalo Henri Mondor
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
Centre Georges François Leclerc
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Hopital Bocage
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Hospitalier Victor Jousselin
City
Dreux
ZIP/Postal Code
28100
Country
France
Facility Name
Clinique Pasteur
City
Evreux
ZIP/Postal Code
27000
Country
France
Facility Name
Centre Hospitalier de Gap
City
Gap
ZIP/Postal Code
05000
Country
France
Facility Name
CHD de Vendée
City
La Roche sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Centre Hsopitalier de La Rochelle
City
La Rochelle
ZIP/Postal Code
17000
Country
France
Facility Name
Centre Hospitalier Robert Boulin
City
Libourne
ZIP/Postal Code
33500
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
Institut Paoli Calmette
City
Marseille
ZIP/Postal Code
13200
Country
France
Facility Name
Centre Val d'Aurèle
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Centre René Gauducheau
City
Nantes
ZIP/Postal Code
44800
Country
France
Facility Name
Hôpital de la Source
City
Orléans
ZIP/Postal Code
45000
Country
France
Facility Name
Groupe Hospitalier Diaconesse Croix Saint Simon
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hôpital Bichat Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Hôpital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Hôpital Robert Debré
City
Reims
ZIP/Postal Code
51000
Country
France
Facility Name
Hôpital Charles Nicolle
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
Clinique Armoricaine de Radiologie
City
Saint Brieuc
ZIP/Postal Code
22000
Country
France
Facility Name
Centre René Huguenin
City
Saint-Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Institut de Cancérologie de la Loire
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Hotel Dieu de France
City
Beirut
Country
Lebanon
Facility Name
Hôpital Saint-Georges
City
Beirut
Country
Lebanon
Facility Name
Makassed General Hospital Tarik Jadide
City
Beirut
Country
Lebanon
Facility Name
Rafik Hariri University Hospital
City
Beirut
Country
Lebanon
Facility Name
Hôpital Saint-Joseph
City
Jdeïdé
Country
Lebanon

12. IPD Sharing Statement

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Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)

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