Masitinib Plus Gemcitabine in Pancreatic Cancer
- Conditions
- Locally Advanced or Metastatic Pancreatic Cancer
- Interventions
- Registration Number
- NCT03766295
- Lead Sponsor
- AB Science
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 377
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo & gemcitabine Placebo Participants receive matching placebo, given orally twice daily, plus gemcitabine at 1000mg/m2 by intravenous infusion during 30 minutes, once every 7 days, for up to 7 weeks, followed by a week of rest. Subsequent cycles should consist of an IV infusion, once every 7 days, for 3 consecutive weeks out of every 4 weeks, until disease progression, death, limiting toxicity or patient consent withdrawal. Masitinib & gemcitabine Masitinib Participants receive masitinib (6 mg/kg/day), given orally twice daily, plus gemcitabine at 1000mg/m2 by intravenous infusion during 30 minutes, once every 7 days, for up to 7 weeks, followed by a week of rest. Subsequent cycles should consist of an IV infusion, once every 7 days, for 3 consecutive weeks out of every 4 weeks, until disease progression, death, limiting toxicity or patient consent withdrawal. Masitinib & gemcitabine Gemcitabine Participants receive masitinib (6 mg/kg/day), given orally twice daily, plus gemcitabine at 1000mg/m2 by intravenous infusion during 30 minutes, once every 7 days, for up to 7 weeks, followed by a week of rest. Subsequent cycles should consist of an IV infusion, once every 7 days, for 3 consecutive weeks out of every 4 weeks, until disease progression, death, limiting toxicity or patient consent withdrawal. Placebo & gemcitabine Gemcitabine Participants receive matching placebo, given orally twice daily, plus gemcitabine at 1000mg/m2 by intravenous infusion during 30 minutes, once every 7 days, for up to 7 weeks, followed by a week of rest. Subsequent cycles should consist of an IV infusion, once every 7 days, for 3 consecutive weeks out of every 4 weeks, until disease progression, death, limiting toxicity or patient consent withdrawal.
- Primary Outcome Measures
Name Time Method Overall Survival (median) From day of randomization to death, assessed for a maximum of 60 months 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.
- Secondary Outcome Measures
Name Time Method Survival rates every 24 weeks The proportion of patients alive at each time point, estimated with Kaplan-Meier distribution
Progression Free Survival From day of randomization to disease progression or death, assessed for a maximum of 60 months 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
Trial Locations
- Locations (9)
Centre Hospitalier de Longjumeau
🇫🇷Longjumeau, France
General University Hospital of Patras
🇬🇷Patras, Greece
Hospital AZ Sint-Jan
🇧🇪Brugge, Belgium
Sanjeevani CBCC USA Cancer Hospital
🇮🇳Raipur, India
National Oncology Institute
🇸🇰Bratislava, Slovakia
Institut Salah Azaiez de Cancerologie
🇹🇳Bab Saadoun, Tunisia
Polyclinique de Limoges site CHENIEUX
🇫🇷Limoges, France
Omsk Clinical oncology dispensary Omsk
🇷🇺Omsk, Russian Federation
Center of Surgical Innovations
🇺🇦Kiev, Ukraine