NCT01308723

A Dose-Finding and Exploratory Study of RO5323441 in Combination With Sorafenib in Patients With Hepatocellular Carcinoma

Exploratory Open Label Dose-escalation Phase Ib Study to Evaluate Safety, Pharmacokinetics and Therapeutic Activity of RO5323441, Administered Intravenously, in Combination With Sorafenib (Nexavar®), in Patients With Advanced or Metastatic and/or Unresectable Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	RO5323441	escalating doses iv
DRUG	RO5323441	iv every 2 weeks
DRUG	sorafenib	400 mg orally twice daily to once every other day

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2011-03-04
• Last updated: 2016-11-02

Locations

2 sites across 1 country: Singapore