A Phase 2 Study of Brivanib in Chinese Patients With Previously Treated Advanced HCC
NCT ID: NCT03516071
Last Updated: 2019-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2017-05-17
2019-07-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Brivanib 800 mg, QD + BSC
Brivanib 800 mg, QD
Brivanib Alaninate 800 mg QD, PO
Brivanib 400 mg, BID + BSC
Brivanib 400 mg, BID
Brivanib Alaninate 400 mg BID, PO
Interventions
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Brivanib 800 mg, QD
Brivanib Alaninate 800 mg QD, PO
Brivanib 400 mg, BID
Brivanib Alaninate 400 mg BID, PO
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Zai Lab (Shanghai) Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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ZL-2301-001
Identifier Type: -
Identifier Source: org_study_id
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