This study will evaluate the efficacy and safety of oral capecitabine plus intravenous (IV) gemcitabine in participants with locally advanced or metastatic pancreatic cancer. The anticipated time on study treatment is 3 to 12 months, and the target sample size is 56 individuals.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Capecitabine will be administered orally at 830 mg/m\^2 BID (equivalent to a total daily dose of 1660 mg/m\^2) as intermittent treatment (given days 1 to 21 q4w).
Gemcitabine will be administered at a dose of 1000 mg/m\^2 once weekly via IV infusion as intermittent treatment (repeated 4-week cycles of 3 weeks treatment and 1 week rest).
Unnamed facility
Buchun, South Korea
Unnamed facility
Daegu, South Korea
Unnamed facility
Seoul, South Korea
Unnamed facility
Seoul, South Korea
Unnamed facility
Overall objective response rate
Time frame: At the end of 6 cycles (24 weeks)
Duration of response
Time frame: Up to approximately 3.5 years
Time to disease progression
Time frame: Up to approximately 3.5 years
Time to response
Time frame: Up to approximately 3.5 years
Time to treatment failure
Time frame: Up to approximately 3.5 years
Overall survival
Time frame: Up to approximately 3.5 years
Incidence of adverse events
Time frame: Up to approximately 3.5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Seoul, South Korea
Unnamed facility
Seoul, South Korea
Unnamed facility
Seoul, South Korea