A Randomised, Placebo-controlled, Double-blind, Multicenter Phase II Trial of Intravenous GC33 at 1600 mg Q2W in Previously Treated Patients With Unresectable Advanced or Metastatic Hepatocellular Carcinoma (HCC)
Description
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 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.
Phase
Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.Inclusion and Exclusion 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
- 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)
Sites
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Washington
- Unknown facility, Seattle, Washington, 98104
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Texas
- Unknown facility, Houston, Texas, 77005
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Missouri
- Unknown facility, St. Louis, Missouri, 63110
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France
- Unknown facility, Clichy, 92118
- Unknown facility, Villejuif, 94804
- Unknown facility, Paris, 75571
- Unknown facility, Vandoeuvre-les-nancy, 54511
- Unknown facility, Angers, 49033
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Germany
- Unknown facility, Freiburg, 79106
- Unknown facility, Heidelberg, 69120
- Unknown facility, Tübingen, 72076
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Spain
- Unknown facility, Zaragoza, 50009
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Veneto
- Unknown facility, Padova, Veneto, 35128
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