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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01693445 | S-1, Oxaliplatin, and Irinotecan for Advanced Gastrointestinal Cancer | PHASE1 | COMPLETED | 22 | — | — | Jun 1, 2012 | Aug 1, 2014 | Feb 19, 2016 | 1 | South Korea |
| Arm | Type | Description |
|---|---|---|
| OIS (Oxaliplatin, Irinotecan, S-1) | EXPERIMENTAL | Dose level 1 treatment will be delivered as a 2-week cycle as bellows; 1. Oxaliplatin 85 mg/m²IV on day 1 2. Irinotecan 120 mg/m² IV on day 1 3. S-1 60 mg/m2/day PO on day 1-7 Dose escalation will be continued until more than one-third of the patients in a given cohort show dose limiting toxicities (DLT) during treatment cycle 1. If at least 2 patients are observed to have DLT, this dose level is defined as the maximum tolerated dose (MTD). If exactly 1 of the 3 patients treated show DLT, 3 additional patients are treated at the current dose level. |
| Name | Type | Description |
|---|---|---|
| OIS (Oxaliplatin, Irinotecan, S-1) | DRUG | Dose level 1 treatment will be delivered as a 2-week cycle as bellows; 1. Oxaliplatin 85 mg/m²IV on day 1 2. Irinotecan 120 mg/m² IV on day 1 3. S-1 60 mg/m2/day PO on day 1-7 Dose escalation will be continued until more than one-third of the patients in a given cohort show dose limiting toxicities (DLT) during treatment cycle 1. If at least 2 patients are observed to have DLT, this dose level is defined as the maximum tolerated dose (MTD). If exactly 1 of the 3 patients treated show DLT, 3 additional patients are treated at the current dose level. |
Inclusion Criteria: * Histologically proven recurrent or metastatic adenocarcinoma of the gastrointestinal tract * Minimum age of 18 years * ECOG Performance status 0-2 * Life expectancy \>3 months * Presence of measurable or evaluable disease by RECIST * Prior adjuvant chemotherapy without S-1, ox...