A phase 2 Study of RO5137382 (GC33) in Patients With Advanced or Metastatic Hepatocellular Carcinoma
- Conditions
- iver Cancer
- Registration Number
- JPRN-jRCT2080221779
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 185
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
- 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival<br>tumor assessments according to RECIST criteria
- Secondary Outcome Measures
Name Time Method - Overall survival <br>- Time to progression (TTP) <br>- Disease control rate (DCR) <br>- Safety <br>- Pharmacokinetics <br>- GPC-3 expression in tumor tissue (biopsy) by immunohistochemistry (IHC) assay <br>CTCAE V4.0,IHC