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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
335

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Bergonie
      • Brest, France, 29200
        • Hopital Morvan
      • Créteil, France, 94000
        • Hôpitalo Henri Mondor
      • Dijon, France, 21000
        • Centre Georges François 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 Léon Bérard
      • 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
        • Hôpital Europeén Georges Pompidou
      • Paris, France, 75020
        • Hôpital Tenon
      • Paris, France, 75018
        • Hopital Bichat Claude Bernard
      • Paris, France, 75012
        • Groupe Hospitalier Diaconesse Croix Saint Simon
      • Reims, France, 51000
        • Hopital Robert Debre
      • Rouen, France, 76000
        • Hôpital Charles Nicolle
      • Saint Brieuc, France, 22000
        • Clinique Armoricaine de Radiologie
      • Saint Priez-en-Jarez, France, 42270
        • Institut de Cancérologie 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AB Science

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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