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

Zai Lab

Status and phase: Completed; Phase 2

Conditions: Hepatocellular Carcinoma (HCC)

Treatments: Drug: Brivanib 800 mg, QD; Drug: Brivanib 400 mg, BID

Study type: Interventional

Funder types: Industry

Identifiers

NCT03516071

ZL-2301-001

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Brivanib 800 mg, QD + BSC

Experimental group

Treatment:

Drug: Brivanib 800 mg, QD

Brivanib 400 mg, BID + BSC

Experimental group

Treatment:

Drug: Brivanib 400 mg, BID