Locally Advanced or Metastatic Pancreatic Cancer
Conditions
Keywords
Pancreatic cancer, tyrosine kinase inhibitor
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).
Interventions
DRUGMasitinib
DRUGGemcitabine
DRUGPlacebo
Sponsors
AB Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main inclusion criteria: 1. Histologically or cytologically confirmed adenocarcinoma of the pancreas, non resectable locally advanced or metastatic stage 2. Patient with pain related to the disease, as assessed by the investigator and the patient: * Pain related to the disease as assessed by the investigator is defined as clinical and documented evaluation by the investigator during physical examinations at screening and/or baseline. * Pain, as assessed by the patient is defined as at least one value out of two values \> 20mm on Visual Analogue Scale at screening or baseline. Visual Analogic scale consists in the visual representation of pain amplitude as perceived by the patient. The amplitude is represented by a 100 mm long line having no reference marks. One extremity indicates an absence of pain (0 value) and the other the worst imaginable pain (100 value). OR \- Patient treated with opioid analgesics at a dose ≥ 1 mg/kg/day (morphinic equivalent). 3\. Chemotherapy naïve patient for the advanced/metastatic disease Main
Exclusion criteria
1. Patient with no pain related to the disease (as defined in the inclusion criterion number 2) 2. Pregnant or nursing female patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Belgium, France, Greece, India, Russia, Slovakia, Tunisia, Ukraine
Outcome results
None listed