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NCT01507168 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Carcinoma, Hepatocellular, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 2
Development phase
185
Enrollment target
20
Study locations

NCT01507168: Completed Phase 2 study of Carcinoma, Hepatocellular, sponsored by Hoffmann-La Roche.

NCT01507168 is a Phase 2 study of Carcinoma, Hepatocellular that has completed, run by Hoffmann-La Roche. The registered enrollment target is 185 participants, below the 606-participant average among 27 other Carcinoma, Hepatocellular trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01507168, a Phase 2 study of Carcinoma, Hepatocellular, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 2
Development phase
185 participants
Enrollment target
20
Study locations

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
Hoffmann-La Roche

909 total trials

What the finished NCT01507168 record still lists

NCT01507168 is an interventional study that assigns participants to a tested intervention. The registered 185 participants enrollment target is mid-sized for trials with a published cap, below the 606-participant average among 27 other Carcinoma, Hepatocellular trials with a reported enrollment target (69% lower).

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.

NCT01507168 names 20 study sites across 8 states, led by Other, New York, California.

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.

What interventions are being tested in trial NCT01507168?

The interventions under investigation include: Placebo (DRUG), GC33 (DRUG).

Who is sponsoring clinical trial NCT01507168?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Carcinoma, Hepatocellular

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01507168's enrollment target sits among peer trials

185 12th of 27 higher than 16 of 27 other Carcinoma, Hepatocellular trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Carcinoma, Hepatocellular trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01507168, the US trial registry maintained by the National Library of Medicine. NCT01507168 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.