Liver Cancer
Phase III Trans-Arterial Chemo-Embolization (TACE) Adjuvant HCC (UW09018)
A Randomized, Double-blind, Multicenter Phase III Study of Brivanib versus Placebo as Adjuvant Therapy to Trans-Arterial Chemo-Emboliztion (TACE) in Patients with Unresectable Hepatocellular Carcinoma: The BRISK TA Study
| Status | Conditions | Phase | Study ID |
| Closed | Liver Cancer | Phase III |
UW09018 NCT00908752 |
Summary
The purpose of this study is to compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy.
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Eligibility Criteria (must meet the following to participate in this study)
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with diagnosis of hepatocellular carcinoma
- Cirrhotic status of Child-Pugh Class A or B with a score of 7
- ECOG performance status of 0 or 1
- Adequate hematologic, hepatic, and renal function
Exclusion criteria:
- Prior use of any systemic anticancer chemotherapy, immunotherapy, investigational or molecular targeted agents for HCC
- History of cardiac disease
- Active and untreated hepatitis B
- Inability to swallow tablets or untreated malabsorption syndrome
- History of human immunodeficiency virus (HIV) infection
Last Updated
December 21, 2012See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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