HCC
Conditions
Keywords
Donafenib, HCC, Advanced, inoperable, Phase 1B
Brief 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) .
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.
Interventions
DRUGDonafenib(200mg)
Donafenib 200mg,bid,po
DRUGDonafenib(300mg)
Donafenib 300mg,bid,po
Sponsors
Tigermed Consulting Co., Ltd
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to progression(TTP) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to symptomatic progression(TTSP) | 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. |
Countries
China
Outcome results
None listed