A Safety and Efficacy Study of RX-0201 Plus Gemcitabine in Metastatic Pancreatic Cancer

Exclusion Criteria

• •Are unwilling or unable to provide informed consent.
• •Are unwilling or unable to comply with the requirements of the protocol.
• •Have been treated with another investigational agent for pancreatic cancer.
• •Have any of the following screening laboratory values:
• •* Hemoglobin \< 8.0 grams/deciliter (g/dL)
• •* Absolute neutrophil count (ANC) \< 1500/microliter (μL)
• •* Platelet count \< 100,000/μL
• •* Serum creatinine \> 1.5 x the institutional upper limit of normal (IULN) creatinine.
• •* Serum bilirubin \> 1.5 X IULN
• •* Aspartate transaminase (AST) (serum glutamic oxaloacetic transaminase, SGOT) \> 2 x IULN (\> 5 x IULN in presence of known liver metastasis)
• •* Alanine transaminase (ALT) (serum glutamate pyruvate transaminase, SGPT) \> 2 x IULN (\> 5 x IULN in presence of known liver metastasis)
• •* Have a prothrombin time \>1.25 x IULN on screening laboratory assessments.
• •* HCV or HBsAg positive subjects
• •Have received therapeutic dose of either warfarin or heparin within 21 days before Day 1 (the first day of dosing; prophylactic use of warfarin or heparin) to maintain patency of indwelling IV catheters/lines is allowed
• •Have a history of brain cancer (primary or metastatic).
• •Have a history of an active hematologic malignancy within the past 2 years.
• •Have an underlying diagnosis or disease state associated with an increased risk of bleeding (i.e., coagulopathies, HIV).
• •Have a serious infection requiring intravenous antibiotic therapy during screening.
• •Females who are pregnant, lactating, or have a positive serum pregnancy test during the screening period.