Safety and Efficacy of Donafenib in Patients With Advanced Hepatocellular Carcinoma
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|ClinicalTrials.gov Identifier: NCT02229071|
Recruitment Status : Completed
First Posted : August 29, 2014
Last Update Posted : March 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|HCC||Drug: Donafenib(200mg) Drug: Donafenib(300mg)||Phase 1 Phase 2|
- 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.
- Patients had prior treatment with sorafenib;
- CNS involvement.
- 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).
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Donafenib in Advanced Hepatocellular Carcinoma: A Randomized Phase 1B Study of Safety, Efficacy, and Pharmacokinetics|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||October 30, 2016|
Donafenib 200 mg orally twice daily,each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Other Name: A Group
Active Comparator: Donafenib(300mg)
Donafenib 300 mg orally twice daily,each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Other Name: B Group
- 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
- Time to progression(TTP) [ Time Frame: 1 year ]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.
- Time to symptomatic progression(TTSP) [ Time Frame: 1 year ]Symtomatic progression is measured with the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-HP) domain of physical wellbeing and additional concerns at baseline and every 4 weeks.TTSP is measured from the date of randomisation until symptomatic progression.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229071
|West China Hospital,SCU|
|Chengdu, Sichuan, China, 610041|
|Principal Investigator:||Feng Bi, Doctor||Sichuan University|