Hepatocellular Carcinoma (HCC)Phase 2NCT03516071
A Phase 2 Study of Brivanib in Chinese Patients With Previously Treated Advanced HCC
A Phase 2 study testing Brivanib 800 mg, QD and Brivanib 400 mg, BID in people with Hepatocellular Carcinoma (HCC), run by Zai Lab (Shanghai) Co., Ltd. at 15 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Brivanib 800 mg, QD and Brivanib 400 mg, BID
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 15 sitesChina
- Study dates
- 17 May 2017to 19 Jul 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
The first Hospital of Jilin University
Changchun, Jilin
Hunan Cancer Hospital
Changsha, Hunan
West China Hospital West China School of Medicine Sichuan University
Chengdu, Sichuan
Nanfang Hospital
Guangzhou, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
Anhui Provincial Hospital
Hefei, Anhui
China PLA 81st hospital
Nanjing, Jiangsu
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Zhongshan Hospital
Shanghai, Shanghai Municipality
Army General Hospital of Shenyang military region
Shenyang, Liaoning
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality
Tangdu Hospital
Xi’an, Shanxi
Henan Cancer Hospital
Zhengzhou, Henan
About this study
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
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.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Brivanib 800 mg, QD, Brivanib 400 mg, BID
- Keywords
- Hepatocellular Carcinoma, HCC, Brivanib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brivanib 800 mg, QDDrug
Brivanib Alaninate 800 mg QD, PO
Brivanib 400 mg, BIDDrug
Brivanib Alaninate 400 mg BID, PO
| Study group | Role | What they receive |
|---|---|---|
| Brivanib 800 mg, QD + BSC | Experimental | Not described Receives: Drug: Brivanib 800 mg, QD |
| Brivanib 400 mg, BID + BSC | Experimental | Not described Receives: Drug: Brivanib 400 mg, BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks from randomization
Time to Progress (TTP)
Defined as the time from random assignment to radiologic disease progression.
Measured: 12 weeks from randomization
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 24 weeks from randomization
Overall survival (OS)
Refers to the duration from randomization to death from any cause
Measured: 24 weeks from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start17 May 2017
- Primary completion9 Nov 2018
- Study completion19 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zai Lab (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516071
- Sponsor's protocol ID
- ZL-2301-001
- Status last verified
- Sep 2019
- First submitted
- 23 Apr 2018
- Last updated
- 4 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03516071
- Acronym / sponsor ID
- ZL-2301-001
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- Hepatocellular Carcinoma, HCC, Brivanib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Zai Lab (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 May 2017 (actual)
- Primary completion
- 9 Nov 2018 (actual)
- Study completion
- 19 Jul 2019 (actual)
- First posted
- 4 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brivanib 800 mg, QD + BSC | Experimental | Drug: Brivanib 800 mg, QD |
| Brivanib 400 mg, BID + BSC | Experimental | Drug: Brivanib 400 mg, BID |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brivanib 800 mg, QDBrivanib Alaninate 800 mg QD, PO | Drug | Brivanib 800 mg, QD + BSC |
| Brivanib 400 mg, BIDBrivanib Alaninate 400 mg BID, PO | Drug | Brivanib 400 mg, BID + BSC |
Primary outcome
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.
4 secondary outcomes
Disease control rate (DCR) at 6 months from randomization
Time frame: 24 weeks from randomization
Progression-free survival (PFS)
Time frame: 24 weeks from randomization
Objective response rate (ORR)
Time frame: 24 weeks from randomization
Overall survival (OS)
Time frame: 24 weeks from randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brivanib 800 mg, QD and Brivanib 400 mg, BID in people with Hepatocellular Carcinoma (HCC), run by Zai Lab (Shanghai) Co., Ltd. at 15 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease control rate (DCR) at 3 months from randomization (time frame: 12 weeks from randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019.