A Study Comparing CO-1.01 With Gemcitabine as First Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma (LEAP)

Inclusion Criteria:

* Metastatic pancreatic ductal adenocarcinoma (i.e., Stage 4).
* Histological/cytological confirmation of metastatic tissue (not primary tumor) by a central pathology laboratory (H\&E stain) to ensure sufficient material is available for later hENT1 analysis.
* Adjuvant chemotherapy/radiotherapy ≥ 6 months prior to randomization.
* Palliative radiotherapy (if administered) ≥ 1 month prior to randomization.
* CT scan ≤30 days prior to randomization
* Performance Status (ECOG) 0 or 1.
* Estimated life expectancy ≥ 12 weeks.
* Age ≥ 18 years.
* Adequate hematological and biological function.
* Written consent on an Institutional Review Board/Institutional Ethics Committee-approved Informed Consent Form prior to any study-specific evaluation.

Exclusion Criteria:

* Prior palliative chemotherapy for pancreatic cancer.
* Radical pancreatic resections (e.g., Whipple procedure) are not allowed \< 6 months prior to randomization. Exploratory laparotomy, palliative (e.g., bypass) surgery, or other procedures (e.g., stents) are not allowed \< 14 days prior to randomization. In both cases the patient must be sufficiently recovered and stable.
* Symptomatic brain metastases.
* Participation in other investigational drug clinical studies ≤ 30 days prior to randomization.
* Concomitant treatment with prohibited medications.
* History of allergy to gemcitabine or eggs.
* Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, uncontrolled intercurrent illness including active infection, arterial thrombosis, symptomatic pulmonary embolism).
* Any disorder that would hamper protocol compliance.
* Prior nonpancreatic malignancy treated with chemotherapy. Prior malignancies treated with surgery or radiotherapy alone must be in remission ≥ 3 years. The following prior malignancies are allowable irrespective of when they occurred: in situ carcinoma of the cervix, in situ ductal breast cancer, low-grade local bladder cancer, and nonmelanotic skin cancer.
* Females who are pregnant or breastfeeding.
* Refusal to use adequate contraception for fertile patients (females and males during the study and for 6 months after the last study treatment). Adequate forms of contraception are double-barrier methods (condoms or diaphragm with spermicidal jelly or foam); oral, depot, or injectable contraceptives; intrauterine devices; tubal ligation.
* Any other reason the investigator considers the patient should not participate in the study.