Phase 2 Study of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subject must be greater than or equal to 18 years of age
Subject must be diagnosed with unresectable or metastatic HCC
Subjects must have a measurable lesion by RECIST on CT scan in at least one site which has not received radiation
Subject has an Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2
No other active malignancy within the past 5 years
Subject has received targeted VEGF/PDGF/TKI therapy. Prior Avastin is allowed
Subject has Child-Pugh grade Class C hepatic impairment
The subject has proteinuria Common Toxicity Criteria (CTC) grade > 1 as measured by routine urinalysis or 24 hour urine collection during screening assessment
Subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure > 100 mmHg or systolic blood pressure > 150 mmHg. Subjects may be re-screened if blood pressure is shown to be controlled with or without intervention
The subject has a documented left ventricular Ejection Fraction < 50%
Subject is receiving therapeutic anticoagulation therapy