Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00553696 | Study Of Sunitinib With S-1 And Cisplatin For Gastric Cancer | PHASE1 | COMPLETED | 27 | — | — | Nov 1, 2007 | Mar 1, 2014 | Mar 13, 2015 | 3 | Japan |
A DLT is any of a predefined set of unacceptable adverse events, regardless of cause. DLTs were assessed during the first cycle (4 weeks).
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Cisplatin | DRUG | Cisplatin 60 mg/m2 on day 1 of each 28 day cycle |
| S-1 | DRUG | S-1 80 mg/m2 on days 1-21 of each 28 day cycle |
| Sunitinib | DRUG | Sunitinib 25 mg, 37.5 mg and 50 mg daily S-1 80 mg/m2 on days 1-21 of each 28 day cycle Cisplatin 60 mg/m2 on day 1 of each 28 day cycle |
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of gastric cancer * Chemonaive patients * Adequate organ function Exclusion Criteria: * Patients who meet the contra-indications of S-1 and Cisplatin. * Prior chemotherapy failure patients