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

Hepatocellular Carcinoma (HCC) Clinical Trial

Official title:

A Multicenter, Randomized, Open-label, Phase II Clinical Study to Evaluate the Efficacy and Safety of Brivanib Alaninate (ZL-2301) Combined With Best Supportive Care (BSC) and Pharmacokinetic Profiles of Brivanib Alaninate in Patients With Advanced Hepatocellular Carcinoma (HCC) Failed or Intolerant of Standard Systemic Chemotherapy and/or Sorafenib

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03516071
• Other study ID #: ZL-2301-001
• Status: Completed
• Phase: Phase 2
• Start date: May 17, 2017
• Est. completion date: July 19, 2019

Study information

• Verified date: September 2019
• Source: Zai Lab (Shanghai) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 19, 2019
• Est. primary completion date: November 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma (HCC)

Intervention

Drug:
• Brivanib 800 mg, QD
Brivanib Alaninate 800 mg QD, PO
• Brivanib 400 mg, BID
Brivanib Alaninate 400 mg BID, PO

Locations

Country	Name	City	State
China	The first Hospital of Jilin University	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	West China Hospital West China School of Medicine Sichuan University	Chengdu	Sichuan
China	Nanfang Hospital	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Anhui Provincial Hospital	Hefei	Anhui
China	China PLA 81st hospital	Nanjing	Jiangsu
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Zhongshan Hospital	Shanghai	Shanghai
China	Army General Hospital of Shenyang military region	Shenyang	Liaoning
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin
China	Tangdu Hospital	Xi'an	Shanxi
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Zai Lab (Shanghai) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks from randomization
Primary	Time to Progress (TTP)	Defined as the time from random assignment to radiologic disease progression.	12 weeks from randomization
Secondary	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.	24 weeks from randomization
Secondary	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.	24 weeks from randomization
Secondary	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	24 weeks from randomization
Secondary	Overall survival (OS)	Refers to the duration from randomization to death from any cause	24 weeks from randomization