Pancreatic Cancer
Conditions
Brief summary
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.
Interventions
DRUGCapecitabine
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).
DRUGGemcitabine
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).
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adult participants 18 to 75 years of age * Locally advanced or metastatic pancreatic cancer
Exclusion criteria
\- Prior chemotherapy for pancreatic cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall objective response rate | At the end of 6 cycles (24 weeks) |
Secondary
| Measure | Time frame |
|---|---|
| Time to response | Up to approximately 3.5 years |
| Time to treatment failure | Up to approximately 3.5 years |
| Time to disease progression | Up to approximately 3.5 years |
| Incidence of adverse events | Up to approximately 3.5 years |
| Duration of response | Up to approximately 3.5 years |
| Overall survival | Up to approximately 3.5 years |
Countries
South Korea
Outcome results
None listed