A Study of GC33 (RO5137382) in Patients With Advanced or Metastatic Hepatocellular Carcinoma
Completed · Phase 2 · Has a placebo group
Conditions studied: Carcinoma, Hepatocellular
In brief
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.
Key facts
- Study ID
- NCT01507168
- Run by
- Hoffmann-La Roche
- People needed
- 185
- Starts
- 2012-02-02
- Expected to finish
- 2015-08-20
- Last updated by the study team
- 2020-04-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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)
Where it is running
- 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
- UCLA Medical Center — Los Angeles, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.