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A Phase I Dose Finding Study of RAD001 in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Advanced Gastric Cancer
It is expected that RAD001 works in gastric cancer by inhibiting PI3K/AKT/mTOR pathway and Hif1A (hypoxia inducible factor 1, alpha subunit), a key player in angiogenesis and the growth of tumors like renal cell carcinoma.However, RAD001 alone looks not enough to control gastric cancer. By the mechanisms above, RAD001 can show additive or synergistic effect in combination with conventional chemotherapy. In this study, XELOX was selected as a conventional combination chemotherapy because it was proven very active and safe in gastric cancer. Combination of XELOX and RAD001 has been never tried for the treatment of cancer patients yet. So, the optimal dose will be first determined in this phase I study
Details
| Lead sponsor | Asan Medical Center |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 40 |
| Start date | 2010-02 |
| Completion | 2013-09 |
Conditions
- Advanced Gastric Cancer
Interventions
- RAD001, Capecitabine, Oxaliplatin
Primary outcomes
- To assess the maximum tolerated dose (MTD) — 1year
Countries
South Korea