Study to Evaluate Efficacy of CO-1.01 as Second Line Therapy for Gemcitabine-Refractory Stage IV Pancreatic Adenocarcinoma

Exclusion Criteria

• •1. Patients who have had stable disease, partial response or complete response to first line gemcitabine-based therapy
• •2. First-line chemotherapy regimen that does not contain gemcitabine
• •3. First-line treatment discontinued due to intolerable gemcitabine-induced toxicity
• •4. Second or subsequent line therapy for advanced disease. Prior exposure to CO-1.01 or prior randomization in a protocol studying CO-1.01 (e.g.,Protocol CO-101-001)
• •5. Tumor that cannot be evaluated for hENT1 expression or that has hENT1 staining in \>50% of cells
• •6. Symptomatic brain metastases
• •7. Concomitant treatment with prohibited medications (e.g., concurrent anticancer therapy including other chemotherapy, radiation, hormonal treatment \[except corticosteroids and megestrol acetate\], or immunotherapy) ≤14 days prior to CO-1.01
• •8. Exploratory laparotomy, palliative (e.g., bypass) surgery, or other procedures are not allowed \<14 days prior to CO-1.01 administration; stenting procedures are permissible at any time prior to dosing; in all cases, the patient must be sufficiently recovered and stable
• •9. History of allergy to gemcitabine or eggs
• •10. Females who are pregnant or breastfeeding
• •11. Refusal to use adequate contraception for fertile patients (females and males during the study and for 6 months after the last dose of CO-1.01)
• •12. Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, psychiatric disturbance, uncontrolled intercurrent illness including active infection, arterial thrombosis, or symptomatic pulmonary embolism)
• •13. Any other reason for which the investigator considers the patient should not participate in the study