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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 185 participants |
| Start Date | 2012-02-02 |
| Est. Completion | 2015-08-20 |
| Phase | Phase 2 |
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.
Learn More About Clinical Trials
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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.
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