Status:
TERMINATED
Phase II Trial of Tivozanib in Advanced Hepatocellular Cancer
Lead Sponsor:
Emory University
Collaborating Sponsors:
AVEO Pharmaceuticals, Inc.
Conditions:
Hepatocellular Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to learn about the effect of the investigational agent tivozanib on the control of the tumor growth in hepatocellular (liver) cancer. The investigators also plan to collec...
Detailed Description
Angiogenesis is the formation of new blood vessels. Angiogenesis is driven by cytokines including vascular endothelial growth factor. Tivozanib is an oral medication that inhibits vascular endothelial...
Eligibility Criteria
Inclusion
- Patients with measurable, histological diagnosis of hepatocellular carcinoma (HCC) and whose disease is not amenable to surgical or regional therapy.
- Prior allowed therapy:
- Surgery including hepatic resection
- Minimum of 4 weeks since any surgical procedure.
- Patients must have adequately recovered from surgery.
- Regional therapy
- Includes transarterial chemoembolization (TACE), drug-eluting bead \[DEB\]-TACE, percutaneous ethanol injection, radiofrequency/cryo ablation, Yttrium-90 radioembolization.
- More than 2 weeks must have lapsed from therapy.
- There must be an indicator lesion outside the treated area or clear evidence of progression in the treated lesion, not amenable for further local therapies.
- Concomitant sorafenib with regional therapy is allowed as long as no evidence of progression on sorafenib.
- Prior adjuvant sorafenib is allowed, if completed more than 6 months prior to disease recurrence.
- Adequate hematological, liver and metabolic organ function.
- Signed informed consent.
Exclusion
- Patients with mixed histology or fibrolamellar variant.
- Prior systemic therapy for metastatic disease.
- Uncontrolled hypertension (HTN).
- Symptomatic heart failure.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01807156
Start Date
March 1 2013
End Date
February 1 2015
Last Update
April 22 2016
Active Locations (1)
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1
Emory University, Winship Cancer Institute
Atlanta, Georgia, United States, 30322