NCT02870569

Phase 2 Trial of Donafenib in 131I-Refractory Differentiated Thyroid Cancer

A Multicenter, Randomized, Open-Label,Phase 2 Trial of Donafenib in 131I-Refractory Differentiated Thyroid Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Donafenib for advanced 131I-refractory/resistant differentiated thyroid cancer(DTC).

Detailed description

This phase 2 study of donafenib, an oral multikinase inhibitor that targets Raf kinase and receptor tyrosine kinases, is to assess efficacy and safety in patients with 131I-refractory/resistant differentiated thyroid cancer.The study is a randomised,multicentre,open-label study.

Conditions

• Differentiated Thyroid Cancer

Interventions

Type	Name	Description
DRUG	Donafenib 200mg	Donafenib is an oral multikinase inhibitor with antiproliferative and antiangiogenic effects.The arm is the lower dose one.
DRUG	Donafenib 300mg	Donafenib is an oral multikinase inhibitor with antiproliferative and antiangiogenic effects.The arm is the higher dose one.

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-07-02
• Completion: 2018-12-01
• First posted: 2016-08-17
• Last updated: 2019-03-01

Locations

1 site across 1 country: China