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A Phase I-II Study of Sorafenib (Nexavar®) in Combination With Capecitabine and Cisplatin (XP) in Patients With Advanced Gastric Cancer
There is strong scientific rationale for exploring the role of sorafenib with capecitabine and cisplatin (XP) in AGC. XP is a new standard of care in AGC and sorafenib is a novel signal transduction inhibitor that prevents tumor cell proliferation and angiogenesis through blockade of the Raf/MEK/ERK pathway at the level of Raf kinase and the receptor tyrosine kinases VEGF-R2 and PDGFR-beta.
Details
| Lead sponsor | Asan Medical Center |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | COMPLETED |
| Enrolment | 22 |
| Start date | 2007-11 |
| Completion | 2009-12 |
Conditions
- Advanced Gastric Cancer
Interventions
- Capecitabine, Cisplatin, Sorafenib
Primary outcomes
- Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) — 28weeks
Number of Participants who Experienced Dose Limiting Toxicities (DLTs) - Progression-free Survival — 1 year
Countries
South Korea