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

NCT01897038

Phase 1 Completed 9 enrolled Hoffmann-La Roche
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

EvaluationDrugModalityDoseRoute
Subject Onartuzumab Monoclonal antibody 10 mg/kg Intravenous
Subject Onartuzumab Monoclonal antibody 15 mg/kg Intravenous
Subject Sorafenib Small molecule 400 mg Oral