drugset / Trial / NCT02406170

Regorafenib in Combination With Paclitaxel in Advanced Oesophagogastric Carcinoma

NCT02406170

Phase 1/2 Completed 47 enrolled Academic Medical Center - University of Amsterdam
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

EvaluationDrugModalityDoseRoute
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