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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
Sponsor:
Collaborator:
Tigermed Consulting Co., Ltd
Information provided by (Responsible Party):
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

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) .

Condition or disease Intervention/treatment Phase
HCC Drug: Donafenib(200mg) Drug: Donafenib(300mg) Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Donafenib(200mg)
Donafenib 200 mg orally twice daily,each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Drug: Donafenib(200mg)
Donafenib 200mg,bid,po
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.
Drug: Donafenib(300mg)
Donafenib 300mg,bid,po
Other Name: B Group




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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China, Sichuan
West China Hospital,SCU
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Tigermed Consulting Co., Ltd
Investigators
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Principal Investigator: Feng Bi, Doctor Sichuan University

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Responsible Party: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier: NCT02229071     History of Changes
Other Study ID Numbers: ZGDH1B
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2015
Keywords provided by Suzhou Zelgen Biopharmaceuticals Co.,Ltd:
Donafenib
HCC
Advanced
inoperable
Phase 1B
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases