ARQ 501 in Combination With Gemcitabine in Subjects With Pancreatic Cancer

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.