drugset / Trial / NCT01973868

Safety and Pharmacokinetics of Regorafenib and Cetuximab in Combination

NCT01973868

Phase 1 Completed 42 enrolled Bayer
NaSingle-groupOpen-labelTreatment

Summary

To establish safety, tolerability and pharmacokinetics of regorafenib and cetuximab in combination, and to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)

Timeline

Start
2013-11-21
Primary completion
2017-01-31
Completion
2018-04-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Subject Regorafenib Small molecule 60 mg Oral
Subject Regorafenib Small molecule 100 mg Oral
Subject Regorafenib Small molecule 120 mg Oral
Subject Regorafenib Small molecule 160 mg Oral

Indications