HCCPhase 1/2NCT02229071
Safety and Efficacy of Donafenib in Patients With Advanced Hepatocellular Carcinoma
A Phase 1/2 study testing Donafenib(200mg) and Donafenib(300mg) in people with HCC, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
This phase IB study of donafenib, an oral multikinase inhibitor that targets Raf kinase and receptor tyrosine kinases, is to assess toxicity,efficacy and pharmacokinetics in patients wiht advanced hepatocellular carcinoma (HCC) . Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HCC
- What is being tested?
- Donafenib(200mg) and Donafenib(300mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- Apr 2014to 30 Oct 2016
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 -70 years old
- Patients with measurable, histologically proven, inoperable HCC
- Child-Pugh (CP) score of A
- Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
- Patients received prior systemic treatments for HCC before 4 weeks
- Patients received operate before 3 months
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- Patients received TACE before 4 weeks
- Life expectancy at least 3 months
- Adequate hepatic and renal function
- Adequate hematologic function (platelet count,≥70×109per liter;hemoglobin ≥8.5 g per deciliter)
- Prothrombin time international normalized ratio≤2; or prothrombin time ≤16 seconds;or APTT≤43s;or TT≤21s.
Who cannot join
- Patients had prior treatment with sorafenib
- CNS involvement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Donafenib in Advanced Hepatocellular Carcinoma: A Randomized Phase 1B Study of Safety, Efficacy, and Pharmacokinetics
This phase IB study of donafenib, an oral multikinase inhibitor that targets Raf kinase and receptor tyrosine kinases, is to assess toxicity,efficacy and pharmacokinetics in patients wiht advanced hepatocellular carcinoma (HCC) .
Read the detailed description
Eligibility Criteria:
- 18 -70 years old;
- Patients with measurable, histologically proven, inoperable HCC;
- Child-Pugh (CP) score of A;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
- Patients received prior systemic treatments for HCC before 4 weeks;
- Patients received operate before 3 months;
- Patients received TACE before 4 weeks;
- Life expectancy at least 3 months;
- Adequate hepatic and renal function;
- Adequate hematologic function (platelet count,≥70×109per liter;hemoglobin ≥8.5 g per deciliter);
- Prothrombin time international normalized ratio≤2; or prothrombin time ≤16 seconds;or APTT≤43s;or TT≤21s.
Exclusion Criteria:
- Patients had prior treatment with sorafenib;
- CNS involvement.
Method:
- open-label,randomized,multiceters study;
- 2 dose cohorts: 200mg bid and 300mg bid;
- Patients with advanced HCC(inoperable) and Child-Pugh (CP) A , randomized,receive continuous donafenib either 200mg bid or 300mg bid in 4 weeks cycles;
- Sample size:106 patients(53 patients in each dose cohort).
Endpoints:
- Safety: toxicities are assessed according to CTCAE 3.0;
- TTP:Tumor response is assessed every two cycles using RECISIT1.1 criteria;
- Donafenib pharmacokinetics is measured in plasma samples.
- Conditions
- HCC
- Being tested
- Donafenib(200mg), Donafenib(300mg)
- Keywords
- Donafenib, HCC, Advanced, inoperable, Phase 1B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donafenib(200mg)Drug
Also called A Group
Donafenib 200mg,bid,po
Donafenib(300mg)Drug
Also called B Group
Donafenib 300mg,bid,po
| Study group | Role | What they receive |
|---|---|---|
| Donafenib(200mg) | Experimental | Donafenib 200 mg orally twice daily,each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops. Receives: Drug: Donafenib(200mg) |
| Donafenib(300mg) | Active comparator | Donafenib 300 mg orally twice daily,each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops. Receives: Drug: Donafenib(300mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Patient visits are scheduled every 4 weeks to monitor safety and drug accountability. Patients were monitored for adverse events by use of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0
Measured: 1 years
Secondary outcomes (1)
Time to progression(TTP)
Patient visits are scheduled every 8 weeks to monitor efficacy.TTP is measured from the date of randomisation until disease progression according to RECIST 1.1.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2015
- Study completion30 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies of the same condition, open and under way.
- More trials run by Suzhou Zelgen Biopharmaceuticals Co.,LtdThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Feng Bi, Doctor, Principal investigator, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229071
- Sponsor's protocol ID
- ZGDH1B
- Status last verified
- Mar 2015
- First submitted
- 26 Aug 2014
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Donafenib in Advanced Hepatocellular Carcinoma: A Randomized Phase 1B Study of Safety, Efficacy, and Pharmacokinetics
- ClinicalTrials.gov ID
- NCT02229071
- Acronym / sponsor ID
- ZGDH1B
- Conditions
- HCC
- Keywords
- Donafenib, HCC, Advanced, inoperable, Phase 1B
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Study start
- Apr 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- 30 Oct 2016 (actual)
- First posted
- 29 Aug 2014 (estimated)
- 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 phase IB study of donafenib, an oral multikinase inhibitor that targets Raf kinase and receptor tyrosine kinases, is to assess toxicity,efficacy and pharmacokinetics in patients wiht advanced hepatocellular carcinoma (HCC) .
Detailed description
Eligibility Criteria:
- 18 -70 years old;
- Patients with measurable, histologically proven, inoperable HCC;
- Child-Pugh (CP) score of A;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
- Patients received prior systemic treatments for HCC before 4 weeks;
- Patients received operate before 3 months;
- Patients received TACE before 4 weeks;
- Life expectancy at least 3 months;
- Adequate hepatic and renal function;
- Adequate hematologic function (platelet count,≥70×109per liter;hemoglobin ≥8.5 g per deciliter);
- Prothrombin time international normalized ratio≤2; or prothrombin time ≤16 seconds;or APTT≤43s;or TT≤21s.
Exclusion Criteria:
- Patients had prior treatment with sorafenib;
- CNS involvement.
Method:
- open-label,randomized,multiceters study;
- 2 dose cohorts: 200mg bid and 300mg bid;
- Patients with advanced HCC(inoperable) and Child-Pugh (CP) A , randomized,receive continuous donafenib either 200mg bid or 300mg bid in 4 weeks cycles;
- Sample size:106 patients(53 patients in each dose cohort).
Endpoints:
- Safety: toxicities are assessed according to CTCAE 3.0;
- TTP:Tumor response is assessed every two cycles using RECISIT1.1 criteria;
- Donafenib pharmacokinetics is measured in plasma samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donafenib(200mg) | Experimental | Drug: Donafenib(200mg)Donafenib 200 mg orally twice daily,each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops. |
| Donafenib(300mg) | Active comparator | Drug: Donafenib(300mg)Donafenib 300 mg orally twice daily,each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 -70 years old
- Patients with measurable, histologically proven, inoperable HCC
- Child-Pugh (CP) score of A
- Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
- Patients received prior systemic treatments for HCC before 4 weeks
Key exclusion criteria (2 listed)
- Patients had prior treatment with sorafenib
- CNS involvement.
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 |
|---|---|---|
| Donafenib(200mg)Also: A GroupDonafenib 200mg,bid,po | Drug | Donafenib(200mg) |
| Donafenib(300mg)Also: B GroupDonafenib 300mg,bid,po | Drug | Donafenib(300mg) |
Primary outcome
Adverse events
Time frame: 1 years
Patient visits are scheduled every 4 weeks to monitor safety and drug accountability. Patients were monitored for adverse events by use of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0
1 secondary outcome
Time to progression(TTP)
Time frame: 1 year
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 22 Mar 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.
Feng Bi, Doctor principal investigator
Sichuan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Donafenib(200mg) and Donafenib(300mg) in people with HCC, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site 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 11 inclusion and 2 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 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Adverse events (time frame: 1 years). 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 22 Mar 2019.