Liver Cancer
Conditions
Interventions
investigational material(s)
Generic name etc : GC33 (RO5137382)
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational
Sponsors
Chugai Pharmaceutical Co., Ltd.
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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 1.1
Exclusion 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 hypersensitivity to similar agents (monoclonal antibody, protein-included drugs, Chinese hamster ovary products)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival tumor assessments according to RECIST criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| - Overall survival - Time to progression (TTP) - Disease control rate (DCR) - Safety - Pharmacokinetics - GPC-3 expression in tumor tissue (biopsy) by immunohistochemistry (IHC) assay CTCAE V4.0,IHC | — |
Outcome results
None listed