Phase 2 Nab® -Paclitaxel (Abraxane®) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC)

This is an international, non-randomized, open-label, multi-center, Phase 2 study in subjects
who are 18 years old or older with locally advanced pancreatic cancer who have not received
prior treatment for their pancreatic cancer. All subjects will be treated with nab-paclitaxel
plus gemcitabine for 6 cycles followed by an Investigator's Choice of continuation of
treatment with nab-paclitaxel plus gemcitabine, chemoradiation therapy, or surgery.

Safety assessments by laboratory testing and physical exams will be conducted through-out the
study.

Efficacy assessments by physical exam will be preformed through-out the study and tumor
imaging will be conducted approximately every 2 months.

Subjects will be considered active study participants from enrollment up to, but not
including, survival follow-up period.

Inclusion Criteria:

- Non- metastasis, unresectable, adenocarcinoma pancreatic cancer patients

- No prior anticancer therapy for pancreatic cancer

•≥ 18 years of age with a performance status of 0 or 1•Adequate complete blood counts,
hepatic function, and renal function

- Signed informed Consent

Exclusion Criteria:

- Active bacterial, viral, or fungal infection

- Infection with hepatitis B or C, or history of human immunodeficiency virus (HIV)
infection, or receiving immunosuppressive or myelosuppressive

- Subjects with sensory neuropathy, ascites, or plastic biliary stent.

- Serious medical risk factors involving any of the major organ systems, or serious
psychiatric disorders (including but not limited to connective tissue disorders, lung
disease, and cardiac or seizure disorders)

- Women who are pregnant or breast feeding