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

Zai Lab (Shanghai) Co., Ltd.90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatocellular Carcinoma (HCC)

Interventions

Brivanib 800 mg, QDDRUG

Brivanib Alaninate 800 mg QD, PO

Brivanib 400 mg, BIDDRUG

Brivanib Alaninate 400 mg BID, PO

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (15)

Anhui Provincial Hospital

Hefei, Anhui, China

Nanfang Hospital

Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Disease control rate (DCR) at 3 months from randomization

Defined as the percentage of patients with complete response, partial response, or stable disease at 12 weeks from randomization by RECIST v1.1.

Time frame: 12 weeks from randomization

Time to Progress (TTP)

Defined as the time from random assignment to radiologic disease progression.

Time frame: 12 weeks from randomization

Secondary Outcomes

Disease control rate (DCR) at 6 months from randomization

Defined as the percentage of patients with complete response, partial response, or stable disease at 24 weeks from randomization by RECIST v1.1.

Time frame: 24 weeks from randomization

Progression-free survival (PFS)

Defined as the time from random assignment until the date of disease progression or death as a result of any cause.

Time frame: 24 weeks from randomization

Objective response rate (ORR)

Defined as the proportion of randomized patients with CR or PR as the optimal response in each treatment group assessed by use of RECIST 1.1 criteria

Time frame: 24 weeks from randomization

Overall survival (OS)

Refers to the duration from randomization to death from any cause

Time frame: 24 weeks from randomization

Data from ClinicalTrials.gov

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