Nab-Paclitaxel+Cisplatin+Gemcitabine in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (PDA)

This is a phase 1b/2 open-label pilot study evaluating the preliminary efficacy and safety
of nab-paclitaxel, cisplatin, and gemcitabine in patients with metastatic pancreatic ductal
adenocarcinoma.

An individual cycle of therapy will be defined as Days 1 and 8 every 21 days. Multiple
cycles may be administered until the patient is withdrawn from therapy.

Overall response rates as well as individual categories of response (complete response-CR,
partial response-PR, stable disease-SD and progressive disease-PD) will be determined using
RECIST 1.1. Time-to-event endpoints, including progression free survival (PFS) and OS
(overall survival) will be assessed using the Kaplan-Meier method. Evaluation of stable
disease at 9 weeks will also be assessed. Toxicity (adverse events) will be recorded using
the NCI CTCAE (v4.0, May 2009).

Inclusion Criteria:

- Age >18 years of age; male or female.

- Histologically or cytologically confirmed metastatic pancreatic ductal
adenocarcinoma.

- Capable of providing informed consent and complying with trial procedures.

- Karnofsky Performance Status (KPS) of >/=70%.

- Life expectancy >/=12 weeks.

- Measurable tumor lesions according to RECIST 1.1 criteria.

- Women must not be able to become pregnant (e.g. post-menopausal for at least 1 year,
surgically sterile, or practicing adequate birth control methods) for the duration of
the study. Women of child bearing potential must have a negative serum or urine
pregnancy test at the Screening Visit and be non-lactating. Both male and female
patients of reproductive potential must agree to use a reliable method of birth
control during the study.

Exclusion Criteria:

- Patients must have received no previous radiotherapy, surgery, chemotherapy or
investigational therapy for the treatment of metastatic disease. Prior treatments in
the adjuvant setting with gemcitabine and/or 5-FU or gemcitabine administered as a
radiation sensitizer are allowed, provided at least 6 months have elapsed since
completion of the last dose and no lingering toxicities are present.

- Palliative surgery and/or radiation treatment less than 4 weeks prior to initiation
of study treatment.

- Exposure to any investigational agent within 4 weeks prior to initiation of study
treatment.

- Evidence of central nervous system (CNS) metastasis (negative imaging study, if
clinically indicated, within 4 weeks of Screening Visit).

- History of other malignancies (except cured basal cell carcinoma, superficial bladder
cancer or carcinoma in situ of the cervix) unless documented free of cancer for >/= 5
years.

- Laboratory values: Screening serum creatinine > upper limits of normal (ULN); total
bilirubin > ULN: alanine aminotransferase (ALT) and AST >/= 2.5 ULN or >/= 5.0 x ULN
if liver metastases are present; absolute neutrophil count < 1,500/mm3, platelet
concentration < 100,00/mm3, hematocrit level < 27% for females or < 30% for males, or
coagulation tests (prothrombin time [PT], partial thromboplastin time [PTT],
International Normalized Ratio [INR]) > 1.5 x ULN unless on therapeutic doses of
warfarin.

- current, serious, clinically significant cardiac arrhythmias as determined by the
Investigator.

- History of HIV infection.

- Active, clinically significant serious infection requiring treatment with
antibiotics, anti-virals or anti-fungals.

- Major surgery within 4 weeks prior to initiation of study treatment. Any condition
that might interfere with the patient's participation in the study or in the
evaluation of the study results.

- Any condition that is unstable and could jeopardize the patient's participation in
the study.