A Dose-Finding and Exploratory Study of RO5323441 in Combination With Sorafenib in Patients With Hepatocellular Carcinoma
Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
Participant gender:
Summary
This open-label study will assess the safety, efficacy and pharmacokinetics of RO5323441 in
combination with sorafenib in patients with advanced or metastatic hepatocellular carcinoma
previously untreated with systemic therapy. In the dose-finding Part I, cohorts of patients
will receive escalating doses of RO5323441 intravenously (iv) every 2 weeks in combination
with sorafenib 400 mg orally twice daily. In the exploratory Part II, patients will be
randomized to receive either the previously established dose of RO5323441 iv every 2 weeks
plus continuous oral sorafenib or sorafenib alone. Anticipated time on study treatment is
until disease progression or unacceptable toxicity occurs. For patients in the sorafenib arm
with disease progression crossover to combination treatment with RO5323441 will be allowed.