1. Subjects who aged 18 years or older
2. Subjects whose written informed consent was obtained complying with the local
regulatory requirements prior to their participation in the trial
3. Subjects who have histologically or cytologically confirmed unresectable or
metastatic epithelial cancer of the exocrine pancreas. High-quality contrast-enhanced
CT scanning is required to evaluate resectability. Measurable disease is not
1. Subjects who have received prior radiation therapy (XRT) for pancreatic cancer unless
progression was documented after XRT and 6 weeks have elapsed between completion of
XRT and start of trial medication.
2. Subjects who have had systemic treatment such as chemotherapy or immunotherapy, for
pancreatic cancer. However, prior use of chemotherapy, e.g. 5-FU or capecitabine, for
radiation sensitization is allowed. If gemcitabine was given in the adjuvant setting,
only subjects relapsed with cancer after 6 months of completing the last dose of
gemcitabine can participate in the trial.
3. Subjects who have had a major surgery within 2 weeks prior to the screening/baseline