Back to resultsA Phase 2 Study of Brivanib in Chinese Patients With Previously Treated Advanced HCC
Primary Purpose
Hepatocellular Carcinoma (HCC)
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Brivanib 800 mg, QD
Brivanib 400 mg, BID
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma (HCC) focused on measuring Hepatocellular Carcinoma, HCC, Brivanib
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
Sites / Locations
- Anhui Provincial Hospital
- Nanfang Hospital
- Sun Yat-sen University Cancer Center
- Harbin Medical University Cancer Hospital
- Henan Cancer Hospital
- Hunan Cancer Hospital
- China PLA 81st hospital
- The first Hospital of Jilin University
- Army General Hospital of Shenyang military region
- Fudan University Shanghai Cancer Center
- Zhongshan Hospital
- Tangdu Hospital
- West China Hospital West China School of Medicine Sichuan University
- Tianjin Medical University Cancer Institute & Hospital
- Zhejiang Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Brivanib 800 mg, QD + BSC
Brivanib 400 mg, BID + BSC
Arm Description
Outcomes
Primary Outcome Measures
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.
Time to Progress (TTP)
Defined as the time from random assignment to radiologic disease progression.
Secondary Outcome Measures
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.
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.
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
Overall survival (OS)
Refers to the duration from randomization to death from any cause
Full Information
NCT ID
NCT03516071
First Posted
April 23, 2018
Last Updated
September 3, 2019
Sponsor
Zai Lab (Shanghai) Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03516071
Brief Title
A Phase 2 Study of Brivanib in Chinese Patients With Previously Treated Advanced HCC
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 17, 2017 (Actual)
Primary Completion Date
November 9, 2018 (Actual)
Study Completion Date
July 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zai Lab (Shanghai) Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma (HCC)
Keywords
Hepatocellular Carcinoma, HCC, Brivanib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brivanib 800 mg, QD + BSC
Arm Type
Experimental
Arm Title
Brivanib 400 mg, BID + BSC
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Brivanib 800 mg, QD
Intervention Description
Brivanib Alaninate 800 mg QD, PO
Intervention Type
Drug
Intervention Name(s)
Brivanib 400 mg, BID
Intervention Description
Brivanib Alaninate 400 mg BID, PO
Primary Outcome Measure Information:
Title
Disease control rate (DCR) at 3 months from randomization
Description
Defined as the percentage of patients with complete response, partial response, or stable disease at 12 weeks from randomization by RECIST v1.1.
Time Frame
12 weeks from randomization
Title
Time to Progress (TTP)
Description
Defined as the time from random assignment to radiologic disease progression.
Time Frame
12 weeks from randomization
Secondary Outcome Measure Information:
Title
Disease control rate (DCR) at 6 months from randomization
Description
Defined as the percentage of patients with complete response, partial response, or stable disease at 24 weeks from randomization by RECIST v1.1.
Time Frame
24 weeks from randomization
Title
Progression-free survival (PFS)
Description
Defined as the time from random assignment until the date of disease progression or death as a result of any cause.
Time Frame
24 weeks from randomization
Title
Objective response rate (ORR)
Description
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
Time Frame
24 weeks from randomization
Title
Overall survival (OS)
Description
Refers to the duration from randomization to death from any cause
Time Frame
24 weeks from randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
Country
China
Facility Name
Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
Country
China
Facility Name
China PLA 81st hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
The first Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Army General Hospital of Shenyang military region
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Tangdu Hospital
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
West China Hospital West China School of Medicine Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Phase 2 Study of Brivanib in Chinese Patients With Previously Treated Advanced HCC
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