advanced/metastatic pancreatic cancer MedDRA version: 14.0 Level: PT Classification code 10033610 Term: Pancreatic carcinoma metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
AB SCIENCE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed adenocarcinoma of the pancreas 2. Chemo naïve patient with advanced/metastatic disease 3. Documented decision justifying non eligibility for surgical resection. The documentation of the non eligibility for surgical resection will be reviewed by an independent committee. 4. Measurable tumor lesions with longest diameter = 20 mm using conventional techniques or = 10 mm with spiral CT scan according RECIST criteria 5. ECOG = 1 6. Patient with a BMI > 18 kg/m² and weighing at least 40kg 7. Patient with organ function as follows: • Absolute neutrophil count (ANC) = 1.5 x 109/L • Haemoglobin = 10 g/dL • Platelets = 100 x 109/L • AST/ALT = 2.5x ULN (= 5 x ULN in case of liver metastases) • GammaGT 12 weeks Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient treated for a cancer other than pancreatic cancer within 5 years before enrollment, with the exception of basal cell carcinoma or cervical cancer in situ 2. Patient with, or with history, of central nervous system (CNS) metastasis 3. Patient with an abnormal cardiac function as defined as: a. Medical history of myocardial infarction b. Medical history of cardiac failure defined as a LVEF < 50% and/or a current treatment for cardiac failure, c. Severe arrhythmia/conduction disorders, defined as severe ventricular arrhythmia; atrioventricular block at second or third level and/or left bundle branch block.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: During this study, an ancillary pharmacogenomic study will be performed in order to define predictive criteria of efficacy (all efficacy variables: survival and tumor assessment) from genomic data. ;Primary end point(s): Overall survival (OS). ;Timepoint(s) of evaluation of this end point: Analyses will be conducted after all patients will have been followed for 12 months (corresponding to 252 events);Main Objective: The objective is to compare efficacy and safety of masitinib at 9 mg/kg/day in combination with gemcitabine, to placebo in combination with gemcitabine, in treatment of patients with advanced/metastatic pancreatic cancer. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Tumor assessment: · OS rate every 6 months · Progression Free Survival (PFS). · Time to Progression (TTP) · Objective response rate (CR + PR) and control disease rate (CR + PR + SD) at week 24, 48 and 72 · Best response along study · Level of serum CA 19-9 at week 24, 48 and 72 | — |
Countries
Czech Republic, France, Hungary, Lebanon, Poland, Romania, United States
Outcome results
None listed