drugset / Trial / NCT02387138
A Trial Assessing Several Schedules of Oral S-1 in Combination With a Fixed Dose of Oxaliplatin and Irinotecan
NaSingle-groupOpen-labelTreatment
Summary
This study is to determine the Maximal Tolerated Dose (MTD), the Dose Limitant Toxicities (DLTs) and the safety profile of S-1 combined with fixed doses of Irinotecan (SIRI schedule) and fixed doses of Irinotecan and Oxaliplatin (SIRINOX schedule).
Timeline
- Start
- 2014-04
- Primary completion
- 2018-06
- Completion
- 2018-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | S-1 | Small molecule | 10 mg/m2 | Oral |
| Subject | S-1 | Small molecule | 15 mg/m2 | Oral |
| Subject | S-1 | Small molecule | 20 mg/m2 | Oral |
| Subject | S-1 | Small molecule | 25 mg/m2 | Oral |
| Subject | S-1 | Small molecule | 30 mg/m2 | Oral |
| Background | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | — |