Status:
COMPLETED
A Study of GC33 (RO5137382) in Patients With Advanced or Metastatic Hepatocellular Carcinoma
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 2 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2015
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT01507168
Start Date
February 2 2012
End Date
August 20 2015
Last Update
April 3 2020
Active Locations (57)
Enter a location and click search to find clinical trials sorted by distance.
1
UCLA Medical Center
Los Angeles, California, United States, 90095
2
National Cancer Institute; Ctr for Cancer Research
Bethesda, Maryland, United States, 20889-0001
3
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
4
Washington Univ School of Med; Barnes-Jewish Hospital; Siteman Cancer Center
St Louis, Missouri, United States, 63110