Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib

AB Science258 enrolled

Overview

The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in the treatment of patients with gastro-intestinal stromal tumor (GIST) after progression with imatinib.

Masitinib is a selective tyrosine kinase inhibitor with potent activity against wild-type c-Kit, the juxta membrane domain of c-Kit, and PDGFR. Masitinib is also thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day with respect to sunitinib at 50 mg/day in the treatment of imatinib-resistant gastro-intestinal stromal tumor (GIST).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

258

Conditions

Gastrointestinal Stromal Tumors

Interventions

MasitinibDRUG

12 mg/kg/day

SunitinibDRUG

50 mg/day

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Main inclusion criteria include: * Patient with histological proven metastatic GIST or non-operable locally advanced GIST * Patient with c-Kit (CD117) positive tumor detected immuno-histochemically * Patient after at least one progression with imatinib at a dose up to 800mg. Progression is defined as a RECIST 1.1 and/or CHOI disease progression while receiving imatinib treatment. Main exclusion criteria include: * 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 * Pregnant, or nursing female patient

Locations (5)

Washington University School of Medicine

St Louis, Missouri, United States

Institut Bergonié

Bordeaux, France

Hôpital l'Archet 2- Service de Cancérologie Digestive

Nice, France

Istituto per la Ricerca e la Cura del Cancro (IRCC)

Candiolo, Italy

Outcomes

Primary 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. If a patient is not known to have died, then OS will be censored at the date of last known date patient alive.

Time frame: From day of randomization to death, assessed for a maximum of 60 months

Secondary Outcomes

Survival rate

Survival rate is defined as the number of patients alive divided by the number of patients in the population of analysis. Assessed at week-8, -16, -24, and every 12 weeks thereafter.

Time frame: Every 12 weeks until study completion, assessed for a maximum of 60 months

Progression Free Survival (PFS)

Progression Free Survival is defined as the time from the randomization date until the date of earliest evidence of disease progression or death, for participants who progressed or died before subsequent cancer therapy. Disease progression will be assessed by the investigator on CT scan according to RECIST 1.1 criteria and/or CHOI criteria.

Time frame: From day of randomization to disease progression or death, assessed for a maximum of 60 months

Data from ClinicalTrials.gov

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