NCT00976170

Study of GC33 and Sorafenib in Combination in Advanced or Metastatic Liver Cancer (Hepatocellular Carcinoma)

A Phase I, Open-Label, Multi-center, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of GC33 in Combination With Sorafenib (Nexavar®) in Patients With Advanced or Metastatic Hepatocellular Carcinoma (HCC).

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Chugai Pharmaceutical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial is studying the safety and best dose of GC33 and Sorafenib in combination in patients with advanced or metastatic liver cancer.

Detailed description

This is a Phase I open-label dose escalation study of GC33 in combination with Sorafenib in patients with advanced or metastatic HCC. This study is designed to evaluate safety, tolerability, pharmacokinetics, and efficacy. Enrollment will proceed until a maximum tolerated dose (MTD) and a recommended Phase II dose has been established.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	GC33(RO5137382)	IV administration at 6 escalating dose levels.
DRUG	Sorafenib	Oral administration at 400mg twice daily or 400mg once daily

Timeline

• Start date: 2009-09-01
• Primary completion: 2013-07-01
• Completion: 2014-09-01
• First posted: 2009-09-14
• Last updated: 2014-10-03

Locations

7 sites across 2 countries: United States, Taiwan