NCT01507168

A Study of GC33 (RO5137382) in Patients With Advanced or Metastatic Hepatocellular Carcinoma

A Randomised, Placebo-controlled, Double-blind, Multicenter Phase II Trial of Intravenous GC33 at 1600 mg Q2W in Previously Treated Patients With Unresectable Advanced or Metastatic Hepatocellular Carcinoma (HCC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized, placebo-controlled, multicenter study will evaluate the efficacy and safety of GC33 (RO5137382) in previously treated patients with unresectable advanced or metastatic hepatocellular carcinoma. Participants will be stratified according to the level of GPC-3 expression in tumors and randomized to receive either GC33 (1600 mg intravenously) or placebo on Days 1 and 8 of Cycle 1 and every 2 weeks thereafter. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	Placebo	iv Days 1 and 8, and every 2 weeks thereafter
DRUG	GC33	1600 mg iv Day 1 and 8, and every 2 weeks thereafter

Timeline

• Start date: 2012-02-02
• Primary completion: 2015-08-20
• Completion: 2015-08-20
• First posted: 2012-01-10
• Last updated: 2020-04-03

Locations

57 sites across 13 countries: United States, Belgium, France, Germany, Hong Kong, Italy, Japan, New Zealand, Singapore, South Korea, Spain, Taiwan, United Kingdom