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

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie (prior sponsor, Abbott)
• Collaborator: Genentech, Inc.

Criteria

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