A Phase 2 Study of Brivanib in Chinese Patients With Previously Treated Advanced HCC

• Status: Completed
• Trial end date: 2019-07-19
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2, Open-label, Randomized, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Brivanib in Patients with Previously Treated Advanced Hepatocellular Carcinoma.

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

Details

• Lead Sponsor: Zai Lab (Shanghai) Co., Ltd.

Criteria

Inclusion Criteria:

• 18-75 years, male or female

• Histologically or cytologically confirmed or the clinical diagnosis standard confirmed hepatocellular carcinoma (HCC) patients

• Failure or intolerance to prior treatment with chemotherapy and/or targeted therapy

• Liver function status Child-Pugh Class A or B (score≤7)

• ECOG Performance Status score 0 or 1

• Patients must have adequate bone marrow, renal and hepatic function

Exclusion Criteria:

• Known history or symptomatic metastatic brain

• Uncontrolled moderate and severe ascites

• With bleeding tendency and thrombosis history

• Known history of severe cardiovascular disease

• Uncontrollable active infections (≥CTCAE Grade 2)

• Pregnant or breastfeeding women