drugset / Trial / NCT01897038
A Safety, Tolerability, and Pharmacokinetics Study of Onartuzumab as Single Agent or in Combination With Sorafenib in Participants With Advanced Hepatocellular Carcinoma
Parallel-groupOpen-labelTreatment
Summary
This multicenter, open-label study will evaluate the maximum tolerated dose (MTD) and dose-limiting toxicities of onartuzumab as single agent or in combination with sorafenib in participants with advanced hepatocellular carcinoma. Participants in Cohort 1 will receive onartuzumab as single agent on Day 1 of each 21-day cycle. Participants in Cohorts 2 or 3 will receive onartuzumab on Day 1 of each 21-day cycle in combination with sorafenib 400 mg orally daily or twice daily. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Timeline
- Start
- 2013-09
- Primary completion
- 2015-03
- Completion
- 2015-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Onartuzumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Onartuzumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | Sorafenib | Small molecule | 400 mg | Oral |