Safety and Efficacy of Donafenib in Patients With Advanced Hepatocellular Carcinoma

• Status: Completed
• Trial end date: 2016-10-30
• Target enrollment: 0
• Participant gender: All

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) .

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Collaborator: Tigermed Consulting Co., Ltd

Criteria

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.