A Study of GC33 (RO5137382) in Patients With Advanced or Metastatic Hepatocellular Carcinoma
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)
2 other identifiers
interventional
185
13 countries
57
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2012
Typical duration for phase_2
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2012
CompletedFirst Posted
Study publicly available on registry
January 10, 2012
CompletedStudy Start
First participant enrolled
February 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2015
CompletedApril 3, 2020
April 1, 2020
3.5 years
January 6, 2012
April 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival (tumor assessments according to RECIST criteria)
approximately 24 months
Secondary Outcomes (6)
Overall survival
approximately 32 months
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
- +1 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORGC33 (RO5137382)
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (57)
UCLA Medical Center
Los Angeles, California, 90095, United States
National Cancer Institute; Ctr for Cancer Research
Bethesda, Maryland, 20889-0001, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Washington Univ School of Med; Barnes-Jewish Hospital; Siteman Cancer Center
St Louis, Missouri, 63110, United States
Columbia University Medical Center
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Vanderbilt Medical Center
Nashville, Tennessee, 37232-7610, United States
Swedish Cancer Inst.
Seattle, Washington, 98104, United States
Hospital Erasme
Brussels, 1070, Belgium
UZ Gent
Ghent, 9000, Belgium
Hotel Dieu; Medecine A
Angers, 49033, France
CHU de GRENOBLE; UF de Cancérologie
Grenoble, 38 043, France
Aphm; Hopital De La Conception
Marseille, 13385, France
Hopital de L'Archet; Pole de Reference Hepatite C
Nice, 06202, France
Hôpital Saint Antoine; Service Hépathologie
Paris, 75571, France
Hopital Purpan;Gastro Enterologie Hepatologie
Toulouse, 31059, France
Hôpital d'Adultes; Service hépato-gastro-entérologie
Vandœuvre-lès-Nancy, 54511, France
Charité Uni.-medizin Berlin, Campus Virchow-Klinikum; Med. Klinik m.S. Hepatologie Gastroenterologie
Berlin, 13353, Germany
Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I
Frankfurt am Main, 60590, Germany
Uni Heidelberg Med. Klinik; Innere Medizin IV
Heidelberg, 69120, Germany
Universitätsklinikum Leipzig
Leipzig, 04103, Germany
Klinikum rechts der Isar der TU München; Klinikapotheke
München, 81675, Germany
Queen Mary Hospital; Dept of Surgery
Pokfulam, Hong Kong
Prince of Wales Hosp; Dept. Of Clinical Onc
Shatin, Hong Kong
Azienda Ospedaliera G. Rummo; Unità Operativa di Oncologia Medica 1
Benevento, Campania, 82100, Italy
Policlinico Universitario Agostino Gemelli
Rome, Lazio, 00168, Italy
Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia
Milan, Lombardy, 20122, Italy
National Cancer Center Hospital East
Chiba, 277-8577, Japan
Kanazawa University Hospital
Ishikawa, 920-8641, Japan
Kanagawa Cancer Center
Kanagawa, 241-8515, Japan
Kindai University Hospital
Osaka, 589-8511, Japan
National Cancer Center Hospital
Tokyo, 104-0045, Japan
Kyorin University Hospital
Tokyo, 181-8611, Japan
Auckland Hospital; New Zealand Liver Transplant Unit
Auckland, 100, New Zealand
National Cancer Centre; Medical Oncology
Singapore, 169610, Singapore
Pusan University Hospital
Busan, 602-739, South Korea
National Cancer Center
Gyeonggi-do, 10408, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Seoul St Mary's Hospital
Seoul, 06591, South Korea
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
Santander, Cantabria, 39008, Spain
Hospital Universitari Vall d'Hebron; Servicio de Hepatologia
Barcelona, 08035, Spain
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona, 08036, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, 28007, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, 28041, Spain
Hospital Universitario Miguel Servet; Servicio Hematologia
Zaragoza, 50009, Spain
Chang Gung Memorial Foundation - Kaohsiung
Kaohsiung City, 00833, Taiwan
Taichung Veterans Gen Hosp
Taichung, 40705, Taiwan
National Cheng Kung Univ Hosp
Tainan, 00704, Taiwan
National Taiwan Uni Hospital; Dept of Oncology
Taipei, 100, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
The Clatterbridge Cancer Ctr NHS Foundation Trust
Bebington, CH63 4JY, United Kingdom
Royal Free Hospital; Dept of Oncology
London, NW3 2QG, United Kingdom
King'S College Hospital; Haematology
London, SE5 9RS, United Kingdom
Related Publications (2)
Pradier MF, Reis B, Jukofsky L, Milletti F, Ohtomo T, Perez-Cruz F, Puig O. Case-control Indian buffet process identifies biomarkers of response to Codrituzumab. BMC Cancer. 2019 Mar 28;19(1):278. doi: 10.1186/s12885-019-5472-0.
PMID: 30922327DERIVEDAbou-Alfa GK, Puig O, Daniele B, Kudo M, Merle P, Park JW, Ross P, Peron JM, Ebert O, Chan S, Poon TP, Colombo M, Okusaka T, Ryoo BY, Minguez B, Tanaka T, Ohtomo T, Ukrainskyj S, Boisserie F, Rutman O, Chen YC, Xu C, Shochat E, Jukofsky L, Reis B, Chen G, Di Laurenzio L, Lee R, Yen CJ. Randomized phase II placebo controlled study of codrituzumab in previously treated patients with advanced hepatocellular carcinoma. J Hepatol. 2016 Aug;65(2):289-95. doi: 10.1016/j.jhep.2016.04.004. Epub 2016 Apr 13.
PMID: 27085251DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2012
First Posted
January 10, 2012
Study Start
February 2, 2012
Primary Completion
August 20, 2015
Study Completion
August 20, 2015
Last Updated
April 3, 2020
Record last verified: 2020-04