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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03223376 | A Phase III Study of Fruquintinib in Combination With Paclitaxel in Second Line Gastric Cancer(FRUTIGA) | PHASE3 | COMPLETED | 703 | — | — | Oct 18, 2017 | Sep 9, 2022 | Dec 1, 2025 | 7 | China |
every two months follow up after EOT observation period at 30 days after the last medication
PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause.
| Arm | Type | Description |
|---|---|---|
| fruquintinib+paclitaxel | ACTIVE_COMPARATOR | treatment arm (fruquintinib+paclitaxel) : Fruquintinib once daily, 3 weeks on/1week off combined with Paclitaxel 80mg/㎡ day1, 8, 15 of 4 weeks cycle. |
| placebo+paclitaxel | PLACEBO_COMPARATOR | control arm (placebo+paclitaxel): Fruquintinib placebo once daily, 3 weeks on/1week off combined with Paclitaxel 80mg/㎡ day1, 8, 15 of 4 weeks cycle. |
| Name | Type | Description |
|---|---|---|
| fruquintinib +paclitaxel | COMBINATION_PRODUCT | treatment arm(fruquintinib +paclitaxel)- subjects will receive Fruquintinib orally, once daily for 3 wks on/ 1 wk off combined with paclitaxel 80mg/㎡ at day 1,8,15 of 4-week cycle. Patients will receive a cycles of 4 weeks of study treatment or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria. |
| fruquintinib placebo + paclitaxel | COMBINATION_PRODUCT | control arm(fruquintinib placebo + paclitaxel)- subjects will receive Fruquintinib placebo orally, once daily for 3 wks on/ 1 wk off combined with paclitaxel 80mg/㎡ at day 1,8,15 of 4-week cycle. Patients will receive a cycles of 4 weeks of study treatment or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria. |
Inclusion Criteria: * Signed informed consent * Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma * Metastatic disease or locally advanced, unresectable disease * Disease progression during or within 4 months after the last dose of the first-line therapy ...