Masitinib in Patients With Gastro-Intestinal Stromal Tumour Resistant to Imatinib

AB Science44 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastro Intestinal Stromal Tumor

Interventions

masitinibDRUG

masitinib 12 mg/kg/day

sunitinibDRUG

sunitinib 50 mg/day

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Histological proven, metastatic, or locally advanced and non-operable GIST 2. Measurable tumor lesions with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan according RECIST criteria 3. C-kit (CD117) positive tumors detected immuno-histochemically and documented mutation of c-kit at any time if available 4. Patients resistant to imatinib at dose of 400 mg/day Exclusion Criteria: 1. Patient treated for a cancer other than GIST cancer within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ 2. Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis

Locations (1)

Institute Gustave Roussy (IGR)

Villejuif, France

Outcomes

Primary Outcomes

overall progression free survival

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 weeks

Time frame: up to 36 weeks

Secondary Outcomes

overall survival

From date of randomization until the date of death from any cause, assessed up to 36 weeks

Time frame: up to 36 weeks

Data from ClinicalTrials.gov

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