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

Phase 2

Completed

• Conditions: Hepatocellular Carcinoma (HCC)
• Interventions: Drug: Brivanib 800 mg, QD; Drug: Brivanib 400 mg, BID

• Registration Number: NCT03516071
• Lead Sponsor: Zai Lab (Shanghai) Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-17
• Study First Submitted: 2018-04-23
• Study First Submitted QC: 2018-04-23
• Study First Posted: 2018-05-04
• Primary Completion: 2018-11-09
• Study Completion: 2019-07-19
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-03
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brivanib 800 mg, QD + BSC	Brivanib 800 mg, QD	-
Brivanib 400 mg, BID + BSC	Brivanib 400 mg, BID	-

Primary Outcome Measures

Name	Time	Method
Disease control rate (DCR) at 3 months from randomization	12 weeks 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 to Progress (TTP)	12 weeks from randomization	Defined as the time from random assignment to radiologic disease progression.

Secondary Outcome Measures

Name	Time	Method
Disease control rate (DCR) at 6 months from randomization	24 weeks 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.
Progression-free survival (PFS)	24 weeks from randomization	Defined as the time from random assignment until the date of disease progression or death as a result of any cause.
Objective response rate (ORR)	24 weeks from randomization	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
Overall survival (OS)	24 weeks from randomization	Refers to the duration from randomization to death from any cause

Trial Locations

Locations (15)

West China Hospital West China School of Medicine Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Anhui Provincial Hospital; 🇨🇳 Hefei, Anhui, China

China PLA 81st hospital; 🇨🇳 Nanjing, Jiangsu, China

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, Heilongjiang, China

The first Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China

Army General Hospital of Shenyang military region; 🇨🇳 Shenyang, Liaoning, China

Tangdu Hospital; 🇨🇳 Xi'an, Shanxi, China

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China

Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China

Nanfang Hospital; 🇨🇳 Guangzhou, Guangdong, China

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

Tianjin Medical University Cancer Institute & Hospital; 🇨🇳 Tianjin, Tianjin, China