drugset / Trial / NCT02406170
Regorafenib in Combination With Paclitaxel in Advanced Oesophagogastric Carcinoma
NaSingle-groupOpen-labelTreatment
Summary
Patients with advanced oesophagogastric cancer (OCG) have a very poor prognosis. After progression on first line therapy, second line chemotherapy with paclitaxel and a VEGF-R2 targeting antibody has a proven benefit on survival. However, no data are available on the combination of paclitaxel with kinase inhibitors in advanced OGC. Here the investigators propose a Phase 1b study to assess the tolerability of regorafenib (an oral multi kinase inhibitor) in combination with paclitaxel and to assess the uptake of paclitaxel in OCG metastasis.
Timeline
- Start
- 2015-04
- Primary completion
- 2019-10
- Completion
- 2019-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Subject | Regorafenib | Small molecule | 40 mg | Oral |
| Subject | Regorafenib | Small molecule | 80 mg | Oral |
| Subject | Regorafenib | Small molecule | 120 mg | Oral |
| Subject | Regorafenib | Small molecule | 160 mg | Oral |