A Phase 2 Study of Brivanib in Chinese Patients With Previously Treated Advanced HCC

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hepatocellular Carcinoma (HCC)

Intervention / Treatment
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* Drug: Brivanib 800 mg, QD
* Drug: Brivanib 400 mg, BID


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brivanib 800 mg, QD + BSC<br> | Drug: Brivanib 800 mg, QD<br>* Brivanib Alaninate 800 mg QD, PO<br>|
| Experimental: Brivanib 400 mg, BID + BSC<br> | Drug: Brivanib 400 mg, BID<br>* Brivanib Alaninate 400 mg BID, PO<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate (DCR) at 3 months 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. | 12 weeks from randomization | 
| Time to Progress (TTP) | Defined as the time from random assignment to radiologic disease progression. | 12 weeks from randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate (DCR) at 6 months from randomization | Defined as the percentage of patients with complete response, partial response, or stable disease at 24 weeks from randomization by RECIST v1.1. | 24 weeks from randomization | 
| Progression-free survival (PFS) | Defined as the time from random assignment until the date of disease progression or death as a result of any cause. | 24 weeks from randomization | 
| Objective response rate (ORR) | Defined as the proportion of randomized patients with CR or PR as the optimal response in each treatment group assessed by use of RECIST 1.1 criteria | 24 weeks from randomization | 
| Overall survival (OS) | Refers to the duration from randomization to death from any cause | 24 weeks from randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular Carcinoma, HCC, Brivanib