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

Roche

Status and phase

Completed

Phase 2

Conditions

Carcinoma, Hepatocellular

Treatments

Drug: GC33

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01507168

2011-003574-84 (EudraCT Number)

NP27884

Details and patient eligibility

About

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.

Enrollment

185 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult patients, >/= 18 years of age
Histologically confirmed hepatocellular carcinoma (without fibro-lamellar subtype)
Prior treatment with at least 1 systemic agent, with documented progressive disease after systemic agent(s), or documented adverse event(s) associated with prior systemic agent(s) that resulted in discontinuance of that (those) agent(s)
Not a candidate for curative treatments (e.g. resection, transplantation)
Child-Pugh A (score of 5-6)
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate hematologic, hepatic and renal function
Ability to provide, for central review, a tumor tissue sample to determine the level of GPC-3 expression by IHC
Measurable disease by RECIST criteria

Exclusion criteria

Child Pugh B or C
Known hepatocellular carcinoma with fibro-lamellar histology
Known brain or leptomeningeal metastases
Active infectious diseases requiring treatment except for hepatitis B and C
History of organ allograft including liver transplant
Anticipated or ongoing administration of anticancer therapies other than those administered in this study
Anticancer treatment within 2 weeks prior to entering the study
Patients who have not fully recovered from toxicities associated with previous HCC loco-regional or systemic therapies
Patients receiving interferon therapy
Pregnant or lactating women
Known HIV positivity or AIDS-related illness
History of significant hypersensitivity to similar agents (monoclonal antibody, protein-included drugs, Chinese hamster ovary products)