Clinical trial NCT03516071: A Phase 2 Study of Brivanib in Chinese Patients With Previously Treated Advanced HCC
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma (HCC)
Keywords: Hepatocellular Carcinoma
HCC
Brivanib
Lead sponsor: Zai Lab (Hong Kong), Ltd.
Sponsor class: INDUSTRY
First posted: 2018-05-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Disease control rate (DCR) at 3 months from randomization
timeFrame: 12 weeks from randomization
measure: Time to Progress (TTP)
timeFrame: 12 weeks from randomization
Secondary outcomes:
measure: Disease control rate (DCR) at 6 months from randomization
timeFrame: 24 weeks from randomization
measure: Progression-free survival (PFS)
timeFrame: 24 weeks from randomization
measure: Objective response rate (ORR)
timeFrame: 24 weeks from randomization
measure: Overall survival (OS)
timeFrame: 24 weeks from randomization
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: China PLA 81st hospital
state: Jiangsu
city: Changchun
country: China
facility: The first Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Army General Hospital of Shenyang military region
state: Liaoning
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital West China School of Medicine Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: