A Study of GC33 (RO5137382) in Patients With Advanced or Metastatic Hepatocellular Carcinoma
NCT ID: NCT01507168
Last Updated: 2020-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
185 participants
INTERVENTIONAL
2012-02-02
2015-08-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo
iv Days 1 and 8, and every 2 weeks thereafter
GC33 (RO5137382)
GC33
1600 mg iv Day 1 and 8, and every 2 weeks thereafter
Interventions
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Placebo
iv Days 1 and 8, and every 2 weeks thereafter
GC33
1600 mg iv Day 1 and 8, and every 2 weeks thereafter
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
St 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
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
Hotel Dieu; Medecine A
Angers, , France
CHU de GRENOBLE; UF de Cancérologie
Grenoble, , France
Aphm; Hopital De La Conception
Marseille, , France
Hopital de L'Archet; Pole de Reference Hepatite C
Nice, , France
Hôpital Saint Antoine; Service Hépathologie
Paris, , France
Hopital Purpan;Gastro Enterologie Hepatologie
Toulouse, , France
Hôpital d'Adultes; Service hépato-gastro-entérologie
Vandœuvre-lès-Nancy, , France
Charité Uni.-medizin Berlin, Campus Virchow-Klinikum; Med. Klinik m.S. Hepatologie Gastroenterologie
Berlin, , Germany
Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I
Frankfurt am Main, , Germany
Uni Heidelberg Med. Klinik; Innere Medizin IV
Heidelberg, , Germany
Universitätsklinikum Leipzig
Leipzig, , Germany
Klinikum rechts der Isar der TU München; Klinikapotheke
München, , 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, Italy
Policlinico Universitario Agostino Gemelli
Rome, Lazio, Italy
Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia
Milan, Lombardy, Italy
National Cancer Center Hospital East
Chiba, , Japan
Kanazawa University Hospital
Ishikawa, , Japan
Kanagawa Cancer Center
Kanagawa, , Japan
Kindai University Hospital
Osaka, , Japan
National Cancer Center Hospital
Tokyo, , Japan
Kyorin University Hospital
Tokyo, , Japan
Auckland Hospital; New Zealand Liver Transplant Unit
Auckland, , New Zealand
National Cancer Centre; Medical Oncology
Singapore, , Singapore
Pusan University Hospital
Busan, , South Korea
National Cancer Center
Gyeonggi-do, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul St Mary's Hospital
Seoul, , South Korea
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 12 de Octubre; Servicio de Oncologia
Madrid, , Spain
Hospital Universitario Miguel Servet; Servicio Hematologia
Zaragoza, , Spain
Chang Gung Memorial Foundation - Kaohsiung
Kaohsiung City, , Taiwan
Taichung Veterans Gen Hosp
Taichung, , Taiwan
National Cheng Kung Univ Hosp
Tainan City, , Taiwan
National Taiwan Uni Hospital; Dept of Oncology
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
The Clatterbridge Cancer Ctr NHS Foundation Trust
Bebington, , United Kingdom
Royal Free Hospital; Dept of Oncology
London, , United Kingdom
King'S College Hospital; Haematology
London, , United Kingdom
Countries
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References
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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.
Abou-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.
Other Identifiers
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2011-003574-84
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NP27884
Identifier Type: -
Identifier Source: org_study_id
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