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Safety and Efficacy of Donafenib in Patients With Advanced Hepatocellular Carcinoma

Primary Purpose

HCC

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Donafenib(200mg)
Donafenib(300mg)
Sponsored by
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HCC focused on measuring Donafenib, HCC, Advanced, inoperable, Phase 1B

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • West China Hospital,SCU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Donafenib(200mg)

Donafenib(300mg)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Adverse events
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

Time to progression(TTP)
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.

Full Information

First Posted
August 26, 2014
Last Updated
March 20, 2019
Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Collaborators
Tigermed Consulting Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02229071
Brief Title
Safety and Efficacy of Donafenib in Patients With Advanced Hepatocellular Carcinoma
Official Title
Donafenib in Advanced Hepatocellular Carcinoma: A Randomized Phase 1B Study of Safety, Efficacy, and Pharmacokinetics
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
October 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Collaborators
Tigermed Consulting Co., Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HCC
Keywords
Donafenib, HCC, Advanced, inoperable, Phase 1B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Donafenib(200mg)
Arm Type
Experimental
Arm Description
Donafenib 200 mg orally twice daily,each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Arm Title
Donafenib(300mg)
Arm Type
Active Comparator
Arm Description
Donafenib 300 mg orally twice daily,each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Intervention Type
Drug
Intervention Name(s)
Donafenib(200mg)
Other Intervention Name(s)
A Group
Intervention Description
Donafenib 200mg,bid,po
Intervention Type
Drug
Intervention Name(s)
Donafenib(300mg)
Other Intervention Name(s)
B Group
Intervention Description
Donafenib 300mg,bid,po
Primary Outcome Measure Information:
Title
Adverse events
Description
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
Time Frame
1 years
Secondary Outcome Measure Information:
Title
Time to progression(TTP)
Description
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.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Time to symptomatic progression(TTSP)
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng Bi, Doctor
Organizational Affiliation
Sichuan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
West China Hospital,SCU
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China

12. IPD Sharing Statement

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Safety and Efficacy of Donafenib in Patients With Advanced Hepatocellular Carcinoma

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