Masitinib in Combination With Gemcitabine for Treatment of Patients With Advanced/Metastatic Pancreatic Cancer

Human pancreatic cancer overexpresses a number of important tyrosine kinase (TK) growth
factors receptors and ligands, including expression of both PDGF and PDGF receptors. Drugs
that can selectively inhibit TKs are likely to be of benefit in pancreatic cancer. Masitinib
is a TK inhibitor, selectively and effectively inhibiting c-Kit (mast cell growth factor
receptor), PDGF receptor, FGF receptor and to a lower extent the FAK kinases. Pre-clinical
and clinical studies have shown that masitinib can reverse resistance of pancreatic tumor
cell lines to gemcitabine. Based on pre-clinical and phase 2 clinical studies, masitinib can
be considered as a good candidate to use in combination with gemcitabine in the treatment of
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