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

Gastrointestinal Stromal Tumors Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00812240
• Other study ID #: AB04030
• Status: Terminated
• Phase: Phase 3
• Start date: January 2009
• Est. completion date: July 2018

Study information

• Verified date: December 2019
• Source: AB Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 335
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

Intervention

Drug:
• Masitinib

• Imatinib
imatinib 400 mg or 600 mg per day, per os

Locations

Country	Name	City	State
France	Centre Hospitalier d'Abbeville	Abbeville
France	Institut Sainte Catherine	Avignon
France	Hôpital Jean Minjoz	Besançon
France	Institut Bergonié	Bordeaux
France	Hôpital Morvan	Brest
France	Hôpitalo Henri Mondor	Créteil
France	Centre Georges François Leclerc	Dijon
France	Hopital Bocage	Dijon
France	Centre Hospitalier Victor Jousselin	Dreux
France	Clinique Pasteur	Evreux
France	Centre Hospitalier de Gap	Gap
France	CHD de Vendée	La Roche sur Yon
France	Centre Hsopitalier de La Rochelle	La Rochelle
France	Centre Hospitalier Robert Boulin	Libourne
France	Centre Oscar Lambret	Lille
France	Centre Léon Bérard	Lyon
France	Institut Paoli Calmette	Marseille
France	Centre Val d'Aurèle	Montpellier
France	Centre René Gauducheau	Nantes
France	Hôpital de la Source	Orléans
France	Groupe Hospitalier Diaconesse Croix Saint Simon	Paris
France	Hôpital Bichat Claude Bernard	Paris
France	Hôpital Européen Georges Pompidou	Paris
France	Hôpital Tenon	Paris
France	Hôpital Robert Debré	Reims
France	Hôpital Charles Nicolle	Rouen
France	Clinique Armoricaine de Radiologie	Saint Brieuc
France	Centre René Huguenin	Saint-Cloud
France	Institut de Cancérologie de la Loire	Saint-Priest-en-Jarez
Lebanon	Hôpital Saint-Georges	Beirut
Lebanon	Hotel Dieu de France	Beirut
Lebanon	Makassed General Hospital Tarik Jadide	Beirut
Lebanon	Rafik Hariri University Hospital	Beirut
Lebanon	Hôpital Saint-Joseph	Jdeïdé
United States	The Emory Clinic	Atlanta	Georgia
United States	Ohio State University	Columbus	Ohio
United States	Henry Ford Health System	Detroit	Michigan
United States	Cancer Centers of the Carolinas	Greenville	South Carolina
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Beth Israel Medical Center	New York	New York
United States	MD Anderson Cancer Center	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AB Science

Countries where clinical trial is conducted

United States,  France,  Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	From day of randomization to disease progression or death, assessed for a maximum of 96 months]
Secondary	Overall Survival (OS)	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