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

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

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 Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma (HCC)
• Intervention / Treatment: Drug: Brivanib 800 mg, QD; Drug: Brivanib 400 mg, BID

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brivanib 800 mg, QD + BSC	Drug: Brivanib 800 mg, QD; Brivanib Alaninate 800 mg QD, PO
Experimental: Brivanib 400 mg, BID + BSC	Drug: Brivanib 400 mg, BID; Brivanib Alaninate 400 mg BID, PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Time to Progress (TTP)	Defined as the time from random assignment to radiologic disease progression.	12 weeks from randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Overall survival (OS)	Refers to the duration from randomization to death from any cause	24 weeks from randomization

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2017
• Primary Completion (Actual): November 9, 2018
• Study Completion (Actual): July 19, 2019

Study Registration Dates

• First Submitted: April 23, 2018
• First Submitted That Met QC Criteria: April 23, 2018
• First Posted (Actual): May 4, 2018

Study Record Updates

• Last Update Posted (Actual): September 4, 2019
• Last Update Submitted That Met QC Criteria: September 3, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Hepatocellular Carcinoma; HCC; Brivanib
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: ZL-2301-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No