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Brivanib

Phase 3

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

Brivanib development status

Highest phase Phase 3 run by Bristol-Myers Squibb (NCT00908752)
Phase scored for ZLABPhase 2
Registered trials 14 across 2 sponsors since Sep 2005

Brivanib target and mechanism

Molecular targetFLT1, FLT4, KDR, FGFR3, FGFR1, FGFR4
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

Brivanib clinical trials

Brivanib · 1 trial · 1 indication

Phase 2 1
NCT03516071A Phase 2 Study of Brivanib in Chinese Patients With Previously Treated Advanced HCCHepatocellular Carcinoma (HCC)
COMPLETED90 Analytics
PHASE2COMPLETED
A Phase 2 Study of Brivanib in Chinese Patients With Previously Treated Advanced HCC
Hepatocellular Carcinoma (HCC)Unlock trial analytics

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 to 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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Frequently asked questions about Brivanib

What is Brivanib?

Brivanib is an investigational small molecule kinase inhibitor being developed by Zai Lab Limited for hepatocellular carcinoma (HCC), the most common form of primary liver cancer. It is a Phase 2 oral agent studied in Chinese patients with previously treated advanced HCC. Brivanib is also referred to as Brivanib 800 mg, QD.

What is Brivanib used for in hepatocellular carcinoma?

Brivanib is being studied for hepatocellular carcinoma (HCC), specifically in patients with advanced disease who have already received prior treatment. The clinical program has focused on Chinese patients with previously treated advanced HCC. It remains investigational and is not an approved therapy for HCC.

What does Brivanib target?

Brivanib targets the vascular endothelial growth factor receptors FLT1, FLT4 and KDR, along with the fibroblast growth factor receptors FGFR1, FGFR3 and FGFR4. As an inhibitor of these receptor kinases, it is designed to block VEGF- and FGF-driven signaling pathways involved in tumor growth and angiogenesis.

Who is developing Brivanib?

Brivanib is being developed by Zai Lab Limited, which trades under the ticker ZLAB. Zai Lab is advancing the compound in oncology, with a development focus on hepatocellular carcinoma in Chinese patients.

What phase is Brivanib in?

Brivanib is in Phase 2 development. It is an investigational drug and has not been approved by the FDA for any indication. The Phase 2 program in hepatocellular carcinoma has been completed, and no trials of Brivanib are currently active.

What clinical trials is Brivanib in?

Brivanib has been evaluated in the Phase 2 trial NCT03516071, titled A Phase 2 Study of Brivanib in Chinese Patients With Previously Treated Advanced HCC. That trial enrolled 90 patients in China, was controlled and randomized, and has been completed. No Brivanib trials are currently active.