drugset / Trial / NCT02178956
A Study of BBI608 Plus Weekly Paclitaxel to Treat Gastric and Gastro-Esophageal Junction Cancer
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to find out whether it is better to receive a new drug, BBI608, in addition to paclitaxel chemotherapy or better to receive paclitaxel chemotherapy alone as second line treatment for gastric and gastroesophageal junction cancer after prior first line platinum and fluoropyrimidine based chemotherapy.
Timeline
- Start
- 2014-10
- Primary completion
- 2017-09-20
- Completion
- 2017-09-20
Outcome
Missed primary endpoint
registry analysis (superiority test); Napabucasin + Paclitaxel vs Placebo + Paclitaxel; p = 0.8596; Hazard Ratio (HR) 1.01 (95% CI 0.86 to 1.02); Log Rank; note: two-sided NCT02178956 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Napabucasin | Small molecule | 480 mg | Oral |
| Background | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |