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Brivanib

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

Clinical trial landscape

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 used for in Hepatocellular Carcinoma (HCC)?

Brivanib is an investigational small molecule being studied for the treatment of Hepatocellular Carcinoma (HCC), a type of liver cancer. It is being developed for patients with previously treated advanced HCC, specifically in a Chinese patient population. The drug is currently in Phase 2 clinical development and is not yet approved.

Who makes Brivanib?

Brivanib is being developed by Zai Lab Limited, a biopharmaceutical company traded on the stock exchange under the ticker symbol ZLAB. The company is conducting clinical trials for Brivanib in the oncology therapeutic area, focusing on Hepatocellular Carcinoma (HCC).

What phase is Brivanib in?

Brivanib is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. A Phase 2 study of Brivanib in Chinese patients with previously treated advanced HCC has been completed, but the drug remains in clinical development.

What clinical trials is Brivanib in?

Brivanib has one completed clinical trial, identified by the National Clinical Trial number NCT03516071. This was a Phase 2 study in Chinese patients with previously treated advanced Hepatocellular Carcinoma (HCC). The trial enrolled 90 participants and was a controlled, randomized study, though it was not double-blind.

Is Brivanib FDA approved?

Brivanib is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Hepatocellular Carcinoma (HCC). The completed Phase 2 trial, NCT03516071, was conducted in China, but no approval status has been established for Brivanib in any market.

How does Brivanib work?

Brivanib is a small molecule, but its specific molecular target has not been disclosed in the available information. As an investigational oncology drug, it is being studied for its potential effect in treating advanced Hepatocellular Carcinoma (HCC), though its exact mechanism of action is not detailed here.