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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capecitabine + Gemcitabine | Experimental | Participants will receive oral capecitabine (830 milligrams per meter-squared [mg/m^2]) twice daily (BID) as intermittent treatment (Days 1 to 21 every 4 weeks [q4w]) along with IV infusion of gemcitabine (1000 mg/m^2) once weekly as intermittent treatment (4-week cycles of 3-week treatment period and 1-week rest period). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall objective response rate | At the end of 6 cycles (24 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response | Up to approximately 3.5 years | |
| Time to disease progression | Up to approximately 3.5 years | |
| Time to response |
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Inclusion Criteria:
Exclusion Criteria:
- Prior chemotherapy for pancreatic cancer
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buchun | 420-021 | South Korea | ||||
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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|
| Gemcitabine | Drug | 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). |
|
| Up to approximately 3.5 years |
| Time to treatment failure | Up to approximately 3.5 years |
| Overall survival | Up to approximately 3.5 years |
| Incidence of adverse events | Up to approximately 3.5 years |
| Daegu |
| South Korea |
| Seoul | 135-720 | South Korea |
| Seoul | 137-702 | South Korea |
| Seoul | 138-736 | South Korea |
| Seoul | 158-710 | South Korea |
| Seoul | South Korea |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |