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

Phase 3TerminatedNCT00812240

AB Science335 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

335

Conditions

Gastrointestinal Stromal Tumors

Interventions

MasitinibDRUG

ImatinibDRUG

imatinib 400 mg or 600 mg per day, per os

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (41)

Outcomes

Primary Outcomes

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).

Time frame: From day of randomization to disease progression or death, assessed for a maximum of 96 months]

Secondary Outcomes

Overall Survival (OS)

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

Data from ClinicalTrials.gov

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MD Anderson Cancer Center

Orlando, Florida, United States

The Emory Clinic

Atlanta, Georgia, United States

Henry Ford Health System

Detroit, Michigan, United States

Beth Israel Medical Center

New York, New York, United States

Ohio State University

Columbus, Ohio, United States

Cancer Centers of the Carolinas

Greenville, South Carolina, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Centre Hospitalier d'Abbeville

Abbeville, France

Institut Sainte Catherine

Avignon, France

Hôpital Jean Minjoz

Besançon, France

...and 31 more locations