A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, 2-parallel Group, Phase III Study to Compare Efficacy and Safety of Masitinib 9 mg/kg/Day in Combination With Gemcitabine Compared to Placebo in Combination With Gemcitabine in Treatment of Patients With Advanced/Metastatic Pancreatic Cancer

Main

Inclusion Criteria:

1. Histologically or cytologically confirmed adenocarcinoma of the pancreas

2. Chemo naïve patients 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. Men and women, age >18 years

5. Men and women of childbearing potential (entering the study after a confirmed
menstrual period and who have a negative pregnancy test), must agree to use two
methods (one for the patient and one for the partner) of medically acceptable forms
of contraception during the study and for 3 months after the last treatment intake.

6. Patient should be able and willing to comply with study visits and procedures as per
protocol.

7. Patient should understand, sign, and date the written voluntary informed consent form
at the screening visit prior to any protocol-specific procedures performed.

Main 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 in situ cervical cancer

2. Any condition that the physician judges could be detrimental to subjects
participating in this study; including any clinically important deviations from
normal clinical laboratory values or concurrent medical events Previous treatment

3. Any anti-tumor therapy (any chemotherapy, radiotherapy, immunotherapy, biologic or
hormonal therapy) within 6 months prior to baseline

4. Treatment with any investigational agent within 4 weeks prior to baseline