drugset / Trial / NCT02312804
Ph Ib/BGJ398/Cervix and Other Solid Tumors
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study will be conducted using 3+3 design and includes, a dose escalation part to define the MTDfRP2D for the combination of BGJ398 and carboplatin/paclitaxel, and a dose expansion part to treat another 12 patients (only cervix cancer) to further evaluate safety of this combination. Safety, tolerability and MTD will be determined in the dose escalation part of the study. The dose expansion will additionally investigate preliminary anti-tumor efficacy in cervical cancer. The dosing cycle is 21 days.
Timeline
- Start
- 2015-01
- Primary completion
- 2015-01
- Completion
- 2015-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | — | Intravenous |
| Subject | Infigratinib | Small molecule | — | Oral |
| Subject | Paclitaxel | Small molecule | — | Intravenous |