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OpenTrials
Completed

NCT Number: NCT02229071

Safety and Efficacy of Donafenib in Patients With Advanced Hepatocellular Carcinoma

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) .

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Key information

Conditions

HCC

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

West China Hospital,SCU

Chengdu, Sichuan, 610041, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Donafenib(200mg)

Drug

Donafenib 200mg,bid,po

Other names: A Group

Donafenib(300mg)

Drug

Donafenib 300mg,bid,po

Other names: B Group

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Other outcomes

  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.

Sponsors and collaborators

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Industry

Collaborators

  • Tigermed Consulting Co., Ltd

Registry information

Official study title

Donafenib in Advanced Hepatocellular Carcinoma: A Randomized Phase 1B Study of Safety, Efficacy, and Pharmacokinetics

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Aug 29, 2014
Registry last updated
Mar 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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