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COMPLETED Phase 2

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

NCT01507168 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG GC33

Study Locations (20)

Other

  • Hospital Erasme — Brussels
  • UZ Gent — Ghent
  • Hotel Dieu; Medecine A — Angers
  • CHU de GRENOBLE; UF de Cancérologie — Grenoble
  • Aphm; Hopital De La Conception — Marseille
  • Hopital de L'Archet; Pole de Reference Hepatite C — Nice
  • Hôpital Saint Antoine; Service Hépathologie — Paris
  • Hopital Purpan;Gastro Enterologie Hepatologie — Toulouse
  • Hôpital d'Adultes; Service hépato-gastro-entérologie — Vandœuvre-lès-Nancy
  • Charité Uni.-medizin Berlin, Campus Virchow-Klinikum; Med. Klinik m.S. Hepatologie Gastroenterologie — Berlin
  • Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I — Frankfurt am Main
  • Uni Heidelberg Med. Klinik; Innere Medizin IV — Heidelberg

New York

  • Columbia University Medical Center — New York
  • Memorial Sloan Kettering Cancer Center — New York

California

  • UCLA Medical Center — Los Angeles

Maryland

  • National Cancer Institute; Ctr for Cancer Research — Bethesda

Michigan

  • Barbara Ann Karmanos Cancer Institute — Detroit

Missouri

  • Washington Univ School of Med; Barnes-Jewish Hospital; Siteman Cancer Center — St Louis

Tennessee

  • Vanderbilt Medical Center — Nashville

Washington

  • Swedish Cancer Inst. — Seattle

Trial Details

FieldValue
Enrollment Target 185 participants
Start Date 2012-02-02
Est. Completion 2015-08-20
Phase Phase 2

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01507168

The ClinicalTrials.gov registry entry for NCT01507168 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 185 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Carcinoma, Hepatocellular appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01507168 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, New York, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01507168 about?

NCT01507168 is a clinical study titled "A Study of GC33 (RO5137382) in Patients With Advanced or Metastatic Hepatocellular Carcinoma". 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 ...

What is the current status of trial NCT01507168?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 185 participants. The study started on 2012-02-02. Estimated completion is 2015-08-20.

What conditions does trial NCT01507168 study?

This clinical trial studies the following conditions: Carcinoma, Hepatocellular. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01507168?

The interventions under investigation include: Placebo (DRUG), GC33 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01507168?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01507168 being conducted?

This trial has 20 study locations across California, Maryland, Michigan, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial