NCT02229071

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) .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2016

Completed
Last Updated

March 22, 2019

Status Verified

March 1, 2015

Enrollment Period

1.7 years

First QC Date

August 26, 2014

Last Update Submit

March 20, 2019

Conditions

HCC

Keywords

DonafenibHCCAdvancedinoperablePhase 1B

Outcome Measures

Primary Outcomes (1)

  • 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

    1 years

Secondary Outcomes (1)

  • Time to progression(TTP)

    1 year

Other Outcomes (1)

  • Time to symptomatic progression(TTSP)

    1 year

Study Arms (2)

Donafenib(200mg)

EXPERIMENTAL

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

Drug: Donafenib(200mg)

Donafenib(300mg)

ACTIVE COMPARATOR

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

Drug: Donafenib(300mg)

Interventions

Donafenib(200mg)DRUG

Donafenib 200mg,bid,po

Also known as: A Group
Donafenib(200mg)
Donafenib(300mg)DRUG

Donafenib 300mg,bid,po

Also known as: B Group
Donafenib(300mg)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients had prior treatment with sorafenib
  • CNS involvement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital,SCU

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Interventions

donafenib

Study Officials

  • Feng Bi, Doctor

    Sichuan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2014

First Posted

August 29, 2014

Study Start

April 1, 2014

Primary Completion

December 1, 2015

Study Completion

October 30, 2016

Last Updated

March 22, 2019

Record last verified: 2015-03

Locations

CN(1)