The objective is to compare efficacy and safety of masitinib in combination with gemcitabine to placebo in combination with gemcitabine, in treatment of patients with locally advanced or metastatic pancreatic cancer and who have pain related to the disease.
Masitinib is a selective tyrosine kinase inhibitor that is thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective of this study is to evaluate the efficacy and safety of masitinib in combination with gemcitabine with respect to placebo in combination with gemcitabine for the treatment of non resectable locally advanced or metastatic pancreatic cancer patients with pain related to the disease. Approximately 330 patients with pain Visual Analogue Scale (VAS) \> 20 and/or treated with 'opioid analgesics' dose ≥ 1 mg/kg/day at baseline will be randomized in a 2:1 ratio to the masitinib and placebo arms, respectively. The primary outcome measure is overall survival (OS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
377
Hospital AZ Sint-Jan
Bruges, Belgium
Polyclinique de Limoges site CHENIEUX
Limoges, France
Centre Hospitalier de Longjumeau
Longjumeau, France
General University Hospital of Patras
Pátrai, Greece
Overall Survival (median)
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
Survival rates
The proportion of patients alive at each time point, estimated with Kaplan-Meier distribution
Time frame: every 24 weeks
Progression Free Survival
Progression Free Survival (PFS) 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
Time frame: From day of randomization to disease progression or death, assessed for a maximum of 60 months
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Sanjeevani CBCC USA Cancer Hospital
Raipur, India
Omsk Clinical oncology dispensary Omsk
Omsk, Russia
National Oncology Institute
Bratislava, Slovakia
Institut Salah Azaiez de Cancerologie
Bab Saadoun, Tunisia
Center of Surgical Innovations
Kiev, Ukraine