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

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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)

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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

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

Hôpital Saint Antoine; Service Hépathologie; 🇫🇷 Paris, France

Charité Uni.-medizin Berlin, Campus Virchow-Klinikum; Med. Klinik m.S. Hepatologie Gastroenterologie; 🇩🇪 Berlin, Germany

Policlinico Universitario Agostino Gemelli; 🇮🇹 Roma, Lazio, Italy

Hospital Universitario 12 de Octubre; Servicio de Oncologia; 🇪🇸 Madrid, Spain

UZ Gent; 🇧🇪 Gent, Belgium

National Cancer Center Hospital; 🇯🇵 Tokyo, Japan

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

National Cancer Center; 🇰🇷 Gyeonggi-do, Korea, Republic of

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

National Cancer Center Hospital East; 🇯🇵 Chiba, Japan

Kindai University Hospital; 🇯🇵 Osaka, Japan

Taichung Veterans Gen Hosp; 🇨🇳 Taichung, Taiwan

Kyorin University Hospital; 🇯🇵 Tokyo, Japan

National Cancer Centre; Medical Oncology; 🇸🇬 Singapore, Singapore

Chang Gung Memorial Foundation - Kaohsiung; 🇨🇳 Kaohsiung, Taiwan

Taipei Veterans General Hospital; 🇨🇳 Taipei City, Taiwan

Hospital Erasme; 🇧🇪 Bruxelles, Belgium

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

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

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

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

Hotel Dieu; Medecine A; 🇫🇷 Angers, France

CHU de GRENOBLE; UF de Cancérologie; 🇫🇷 Grenoble, France

Aphm; Hopital De La Conception; 🇫🇷 Marseille, France

Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I; 🇩🇪 Frankfurt Am Main, Germany

Hopital de L'Archet; Pole de Reference Hepatite C; 🇫🇷 Nice, France

Hopital Purpan;Gastro Enterologie Hepatologie; 🇫🇷 Toulouse, France

Uni Heidelberg Med. Klinik; Innere Medizin IV; 🇩🇪 Heidelberg, Germany

Hôpital d'Adultes; Service hépato-gastro-entérologie; 🇫🇷 Vandoeuvre-les-nancy, France

Klinikum rechts der Isar der TU München; Klinikapotheke; 🇩🇪 Muenchen, Germany

Azienda Ospedaliera G. Rummo; Unità Operativa di Oncologia Medica 1; 🇮🇹 Benevento, Campania, Italy

Prince of Wales Hosp; Dept. Of Clinical Onc; 🇭🇰 Shatin, Hong Kong

Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia; 🇮🇹 Milano, Lombardia, Italy

Kanazawa University Hospital; 🇯🇵 Ishikawa, Japan

Kanagawa Cancer Center; 🇯🇵 Kanagawa, Japan

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul St Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Auckland Hospital; New Zealand Liver Transplant Unit; 🇳🇿 Auckland, New Zealand

Hospital Universitario Marques de Valdecilla; Servicio de Oncologia; 🇪🇸 Santander, Cantabria, Spain

Hospital Universitari Vall d'Hebron; Servicio de Hepatologia; 🇪🇸 Barcelona, Spain

Hospital Clínic i Provincial; Servicio de Hematología y Oncología; 🇪🇸 Barcelona, Spain

Hospital General Universitario Gregorio Marañon; Servicio de Oncologia; 🇪🇸 Madrid, Spain

Hospital General Universitario Gregorio Marañon; 🇪🇸 Madrid, Spain

Hospital Universitario Clínico San Carlos; Servicio de Oncologia; 🇪🇸 Madrid, Spain

Hospital Universitario Miguel Servet; Servicio Hematologia; 🇪🇸 Zaragoza, Spain

National Cheng Kung Univ Hosp; 🇨🇳 Tainan, Taiwan

National Taiwan Uni Hospital; Dept of Oncology; 🇨🇳 Taipei, Taiwan

Royal Free Hospital; Dept of Oncology; 🇬🇧 London, United Kingdom

The Clatterbridge Cancer Ctr NHS Foundation Trust; 🇬🇧 Bebington, United Kingdom

King'S College Hospital; Haematology; 🇬🇧 London, United Kingdom

Universitätsklinikum Leipzig; 🇩🇪 Leipzig, Germany

Pusan University Hospital; 🇰🇷 Busan, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Queen Mary Hospital; Dept of Surgery; 🇭🇰 Pokfulam, Hong Kong