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

Phase 2

Completed

• Conditions: Carcinoma, Hepatocellular
• Interventions: Drug: Placebo; Drug: GC33

• Registration Number: NCT01507168
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-06
• Study First Submitted QC: 2012-01-06
• Study First Posted: 2012-01-10
• Study Start: 2012-02-02
• Primary Completion: 2015-08-20
• Study Completion: 2015-08-20
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-01
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
GC33 (RO5137382)	GC33	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival (tumor assessments according to RECIST criteria)	approximately 24 months

Secondary Outcome Measures

Name	Time	Method
Overall survival	approximately 32 months
GPC-3 expression in tumor tissue (biopsy) by immunohistochemistry (IHC) assay	at screening
Time to progression (TTP): Time from randomization to first documented disease progression	approximately 24 months
Disease control rate (DCR): Complete response, partial response or stable disease lasting at least 6 weeks	approximately 24 months
Safety: Incidence of adverse events	approximately 24 months
Pharmacokinetics: Serum concentrations (Cmax,Cmin)	Multiple sampling pre- and post-dose Days 1 and 8 Cycle 1, Day 1 Cycle 6, pre-dose Day 1 Cycles 2-11

Trial Locations

Locations (57)

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

National Cancer Institute; Ctr for Cancer Research; 🇺🇸 Bethesda, Maryland, United States

Barbara Ann Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

Washington Univ School of Med; Barnes-Jewish Hospital; Siteman Cancer Center; 🇺🇸 Saint Louis, Missouri, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Vanderbilt Medical Center; 🇺🇸 Nashville, Tennessee, United States

Swedish Cancer Inst.; 🇺🇸 Seattle, Washington, United States

Hospital Erasme; 🇧🇪 Bruxelles, Belgium

UZ Gent; 🇧🇪 Gent, Belgium

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