RX-3117 in Combination With Abraxane® in Subjects With Metastatic Pancreatic Cancer

Inclusion Criteria

Disease Related

• Subject has confirmed histologic or cytologic evidence of metastatic pancreatic cancer and has no prior treatment for metastatic pancreatic cancer.
• Subject has measurable disease using Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1.
• Subject has a life expectancy of at least 3 months.
• Subject has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

Demographic

• Males or females ≥ 18 years of age
• Subject must be able to swallow capsules
• Subject must have adequate venous access for intravenous (IV) infusion

Laboratory

• Subject has hemoglobin ≥ 9.0 g/dL at Screening
• Subject has absolute neutrophil count (ANC) ≥ 1.5 x 109/L at Screening
• Subject has platelet count ≥ 100 x 109/L at Screening
• Subject has serum creatinine ≤ 1.5 times the upper limit of normal (ULN) at Screening. Subjects with serum creatinine levels > 1.5 times the ULN must have a 24-hour urine creatinine clearance ≥ 60 mL/min
• Subject has serum bilirubin ≤ 1.5 times the ULN (except in subjects with Gilbert's Syndrome who must have serum bilirubin < 3.0 x ULN)
• Subject has aspartate aminotransferase (AST; SGOT) and alanine aminotransferase (ALT; SGPT) ≤ 2.5 times the ULN (OR, AST and ALT ≤ 5 times the ULN in the presence of known liver metastases)
• Subject has alkaline phosphatase ≤ 2.5 times the ULN (OR ≤ 5 times the ULN in the presence of known liver or bone metastases)
• Subject has normal coagulation parameters (prothrombin time [PT] and/or international normalized ratio [INR], and partial thromboplastin time [PTT] within normal limits [<1.2 x ULN])
• Subject has potassium concentration within normal range, or correctable with supplements.
• Oxygen saturation by pulse oximetry ≥ 92% at rest.
• For women of childbearing potential: Negative serum pregnancy test during screening and negative serum or urine pregnancy test at start of study therapy (Cycle1 Day 1).

Reproductive

• For female subjects of childbearing potential, willingness to abstain from heterosexual intercourse or use a protocol-recommended method of contraception from the screening visit throughout the study treatment period and for 30 days following the last dose of study drug.
• Female subjects of non-childbearing potential defined as having amenorrhea for at least 24 consecutive months, a documented hysterectomy, or a documented bilateral oophorectomy)
• For fertile male subjects having intercourse with females of childbearing potential, willingness to abstain from heterosexual intercourse or use a protocol-recommended method of contraception from the start of study therapy throughout the study treatment period and for 30 days following the last dose of study drug and to refrain from sperm donation from the start of study treatment throughout the study treatment period and for 30 days following the last dose of study drug.

Ethical

• In the judgment of the investigator, participation in the protocol offers an acceptable benefit-to-risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the subject's cancer.
• Before any study-specific procedure, the appropriate written informed consent must be obtained

Exclusion Criteria

Disease Related

• Subject has primary brain tumors or clinical evidence of active brain metastasis
• Subject has undergone major surgery within 4 weeks of the start of study treatment. Laparoscopy and central venous catheter placement are not considered major surgery

Medications

• Subject has a history of systemic corticosteroid use within 7 days before Day 1 of Cycle 1

General

• Subject has an active infection requiring parenteral or oral antibiotics within 2 weeks before planned start of study therapy
• Subject has uncontrolled diabetes as assessed by the investigator
• Subject has a second malignancy other than curatively resected basal cell carcinoma of the