drugset / Trial / NCT01973868
Safety and Pharmacokinetics of Regorafenib and Cetuximab in Combination
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |