Clinical Trials

Inclusion Criteria:

• Subjects greater than or equal to (≥) 18 years of age with locally advanced unresectable or metastatic pancreatic adenocarcinoma proven by histology or cytology and previously untreated with chemotherapy or systemic therapy other than:
  • Radiosensitizing doses of 5-fluorouracil;
  • Radiosensitizing doses of gemcitabine if relapse occurred at least 6 months after completion of gemcitabine;
  • Neoadjuvant chemotherapy if relapse occurred at least 6 months after surgical resection;
  • Adjuvant chemotherapy if relapse occurred at least 6 months after completion of adjuvant chemotherapy
• Subjects may have measurable or non-measurable disease according to RECIST 1.1.
• Eastern cooperative oncology group (ECOG) performance status of 0 or 1
• Acceptable hematological status, liver and renal function as defined in the protocol
• Other protocol defined inclusion criteria could apply

Exclusion Criteria:

• Significant cardiac or peripheral vascular arterial disease
• Known brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 3 months)
• Severe chronic obstructive or other pulmonary disease with hypoxemia
• Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
• Subjects receiving concomitant treatment with radiotherapy or other investigational drugs
• Other protocol defined exclusion criteria could apply