A Phase II Study of ARQ 501 in Combination With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma

Inclusion Criteria:

- Have a pathologically confirmed diagnosis of unresectable, metastatic pancreatic
adenocarcinoma

- Be treatment-naïve.

- Have measurable disease per RECIST Criteria.

- Be ≥18 years old.

- Have a Karnofsky Performance Status (KPS) of ≥70%.

- Have an estimated life expectancy of ≥12 weeks.

- Be male or a non-pregnant, non-lactating female patient. Patients who are fertile
agree to use an effective barrier method of birth control (e.g., latex condom,
diaphragm, or cervical cap) to avoid pregnancy.

- Have a negative serum or urine pregnancy test within 7 days prior to the first dose
of study drug (if patient is a female of childbearing potential).

- Sign a written informed consent form.

- Have adequate organ function as indicated by acceptable laboratory values obtained
within 7 days prior to the first dose of study drug.

Exclusion Criteria:

- Have received any prior therapy for the treatment of their pancreatic malignancy
(including chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major
surgery, or irradiation, whether conventional or investigational).

- Have an active, uncontrolled systemic infection considered opportunistic, life
threatening or clinically significant at the time of treatment.

- Are pregnant or lactating.

- Have a psychiatric disorder(s) that would interfere with consent, study
participation, or follow-up.

- Have any other severe concurrent disease, which, in the judgment of the investigator,
would make the patient inappropriate for entry into this study.

- Have symptomatic or untreated central nervous system (CNS) metastases.

- Have a known hypersensitivity to gemcitabine.