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

NCT01507168 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2020-04-03

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-02
Primary Completion
2015-08-20
Completion
2015-08-20

Countries

  • United States
  • Belgium
  • France
  • Germany
  • Hong Kong
  • Italy
  • Japan
  • New Zealand
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01507168 on ClinicalTrials.gov