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

December 2, 2019 updated by: AB Science

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

335

Phase

  • Phase 3

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

  • France
      • Abbeville, France, 80142
        • Centre Hospitalier d'Abbeville
      • Avignon, France, 84000
        • Institut Sainte Catherine
      • Besançon, France, 25000
        • Hôpital Jean Minjoz
      • Bordeaux, France, 33000
        • Institut Bergonié
      • Brest, France, 29200
        • Hopital Morvan
      • Créteil, France, 94000
        • Hôpitalo Henri Mondor
      • Dijon, France, 21000
        • Centre Georges Francois Leclerc
      • Dijon, France, 21079
        • Hôpital Bocage
      • Dreux, France, 28100
        • Centre Hospitalier Victor Jousselin
      • Evreux, France, 27000
        • Clinique Pasteur
      • Gap, France, 05000
        • Centre Hospitalier de Gap
      • La Roche sur Yon, France, 85925
        • CHD de Vendée
      • La Rochelle, France, 17000
        • Centre Hsopitalier de La Rochelle
      • Libourne, France, 33500
        • Centre hospitalier Robert Boulin
      • Lille, France, 59000
        • Centre Oscar Lambret
      • Lyon, France, 69000
        • Centre Leon Berard
      • Marseille, France, 13200
        • Institut Paoli Calmette
      • Montpellier, France, 34000
        • Centre Val d'Aurèle
      • Nantes, France, 44800
        • Centre Rene Gauducheau
      • Orléans, France, 45000
        • Hôpital de la Source
      • Paris, France, 75015
        • Hopital Europeen Georges Pompidou
      • Paris, France, 75020
        • Hopital Tenon
      • Paris, France, 75018
        • Hopital Bichat Claude Bernard
      • Paris, France, 75012
        • Groupe Hospitalier Diaconesse Croix Saint Simon
      • Reims, France, 51000
        • Hôpital Robert Debré
      • Rouen, France, 76000
        • Hopital Charles Nicolle
      • Saint Brieuc, France, 22000
        • Clinique Armoricaine de Radiologie
      • Saint Priez-en-Jarez, France, 42270
        • Institut de Cancerologie de La Loire
      • Saint-Cloud, France, 92210
        • Centre René Huguenin
  • Lebanon
      • Beirut, Lebanon
        • Rafik Hariri University Hospital
      • Beirut, Lebanon
        • Hotel Dieu de France
      • Beirut, Lebanon
        • Hôpital Saint-Georges
      • Beirut, Lebanon
        • Makassed General Hospital Tarik Jadide
      • Metn, Lebanon
        • Hôpital Saint-Joseph
      • Metn, Lebanon
        • Middle East Institute of Health- Bsaleem
      • Saida, Lebanon
        • Hammoud Hospital University Medical Center
  • United States
    • Florida
      • Orlando, Florida, United States, 32806
        • MD Anderson Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • The Emory Clinic
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • New York
      • New York, New York, United States, 10003
        • Beth Israel Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • South Carolina
      • Greenville, South Carolina, United States, 290605
        • Cancer Centers of the Carolinas
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College Of Wisconsin

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

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Masitinib (7.5)
Participants receive masitinib (7.5 mg/kg/day), given orally twice daily.
Drug: Masitinib
Other Names:
  • AB1010
Experimental: Masitinib (6.0)
Participants receive masitinib (6.0 mg/kg/day), given orally twice daily
Drug: Masitinib
Other Names:
  • AB1010
Active Comparator: Active Comparator (7.5)
Participants receive imatinib at 400 or 600 mg per day
Drug: Imatinib
imatinib 400 mg or 600 mg per day, per os
Other Names:
  • Gleevec
Active Comparator: Active Comparator (6.0)
Participants receive imatinib at 400 or 600 mg per day
Drug: Imatinib
imatinib 400 mg or 600 mg per day, per os
Other Names:
  • Gleevec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: From day of randomization to disease progression or death, assessed for a maximum of 96 months]
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).
From day of randomization to disease progression or death, assessed for a maximum of 96 months]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From day of randomization to death, assessed for a maximum of 96 months
Overall survival is defined as time in months from the randomization date to the date of death due to any cause
From day of randomization to death, assessed for a maximum of 96 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AB Science

Investigators

  • Principal Investigator: Antoine Adenis, MD, Centre Oscar Lambret, Lille, France

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)

January 1, 2009

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

December 19, 2008

First Submitted That Met QC Criteria

December 19, 2008

First Posted (Estimate)

December 22, 2008

Study Record Updates

Last Update Posted (Actual)

December 4, 2019

Last Update Submitted That Met QC Criteria

December 2, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB04030

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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 Gastrointestinal Stromal Tumors

Clinical Trials on Masitinib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe