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

Zai Lab (Shanghai) Co., Ltd.15 sites in 1 country90 target enrollmentMay 17, 2017

ConditionsHepatocellular Carcinoma (HCC)

InterventionsBrivanib 800 mg, QD Brivanib 400 mg, BID

DrugsBrivanib 800 mg, QD Brivanib 400 mg, BID

Overview

Phase: Phase 2
Intervention: Brivanib 800 mg, QD
Conditions: Hepatocellular Carcinoma (HCC)
Sponsor: Zai Lab (Shanghai) Co., Ltd.
Enrollment: 90
Locations: 15
Primary Endpoint: Disease control rate (DCR) at 3 months from randomization
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 17, 2017

End Date

July 19, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Zai Lab (Shanghai) Co., Ltd.

Responsible Party

Sponsor

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

Arms & Interventions

Brivanib 800 mg, QD + BSC

Intervention: Brivanib 800 mg, QD

Brivanib 400 mg, BID + BSC

Intervention: Brivanib 400 mg, BID

Outcomes

Primary Outcomes

Disease control rate (DCR) at 3 months from randomization

Time Frame: 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)

Time Frame: 12 weeks from randomization

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

Secondary Outcomes

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)
Overall survival (OS)(24 weeks from randomization)