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
1 other identifier
interventional
90
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2017
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 17, 2017
CompletedFirst Submitted
Initial submission to the registry
April 23, 2018
CompletedFirst Posted
Study publicly available on registry
May 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 19, 2019
CompletedSeptember 4, 2019
September 1, 2019
1.5 years
April 23, 2018
September 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Disease control rate (DCR) at 6 months from randomization
24 weeks from randomization
Progression-free survival (PFS)
24 weeks from randomization
Objective response rate (ORR)
24 weeks from randomization
Overall survival (OS)
24 weeks from randomization
Study Arms (2)
Brivanib 800 mg, QD + BSC
EXPERIMENTALBrivanib 400 mg, BID + BSC
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Anhui Provincial Hospital
Hefei, Anhui, China
Nanfang Hospital
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Hunan Cancer Hospital
Changsha, Hunan, China
China PLA 81st hospital
Nanjing, Jiangsu, China
The first Hospital of Jilin University
Changchun, Jilin, China
Army General Hospital of Shenyang military region
Shenyang, Liaoning, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Tangdu Hospital
Xi’an, Shanxi, China
West China Hospital West China School of Medicine Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2018
First Posted
May 4, 2018
Study Start
May 17, 2017
Primary Completion
November 9, 2018
Study Completion
July 19, 2019
Last Updated
September 4, 2019
Record last verified: 2019-09