Phase 2 Study of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)

An Open-label, Phase 2 study of efficacy and tolerability of ABT-869 in advanced hepatocellular carcinoma (HCC)

Inclusion criteria

• 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

Exclusion criteria

• 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