Safety and Efficacy of Donafenib in Patients With Advanced Hepatocellular Carcinoma

NCT ID: NCT02229071

Last Updated: 2019-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-10-30

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.

Conditions

HCC

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Donafenib(200mg)

Donafenib 200 mg orally twice daily,each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.

Group Type: EXPERIMENTAL

Donafenib(200mg)

Intervention Type: DRUG

Donafenib 200mg,bid,po

Donafenib(300mg)

Donafenib 300 mg orally twice daily,each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.

Group Type: ACTIVE_COMPARATOR

Donafenib(300mg)

Intervention Type: DRUG

Donafenib 300mg,bid,po

Interventions

Donafenib(200mg)

Donafenib 200mg,bid,po

Intervention Type: DRUG

Donafenib(300mg)

Donafenib 300mg,bid,po

Intervention Type: DRUG

Other Intervention Names

A Group; B Group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tigermed Consulting Co., Ltd

INDUSTRY

Sponsor Role: collaborator

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Feng Bi, Doctor

Role: PRINCIPAL_INVESTIGATOR

Sichuan University

Locations

West China Hospital,SCU

Chengdu, Sichuan, China

Countries

China

Other Identifiers

ZGDH1B

Identifier Type: -

Identifier Source: org_study_id