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Brivanib ,

Phase 2

Hepatocellular Carcinoma (HCC) | Small molecule | Oncology |Zai Lab Limited|Last Updated: Sep 4, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment90
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03516071A Phase 2 Study of Brivanib in Chinese Patients With Previously Treated Advanced HCCPHASE2 COMPLETED 90May 17, 2017Jul 19, 2019Sep 4, 201915 China
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Study Endpoints
Primary Endpoints
Disease control rate (DCR) at 3 months from randomization
12 weeks 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.

Time to Progress (TTP)
12 weeks from randomization

Defined as the time from random assignment to radiologic disease progression.

Secondary Endpoints
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
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Brivanib 800 mg, QD + BSCEXPERIMENTAL -
Brivanib 400 mg, BID + BSCEXPERIMENTAL -
Interventions
NameTypeDescription
Brivanib 800 mg, QDDRUGBrivanib Alaninate 800 mg QD, PO
Brivanib 400 mg, BIDDRUGBrivanib Alaninate 400 mg BID, PO
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites15

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...

Countries:China
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