Donafenib in 131I-Refractory Differentiated Thyroid Cancer
Donafenib in 131I-Refractory Differentiated Thyroid Cancer
Brief Summary:
Donafenib for advanced 131I-refractory/resistant differentiated thyroid cancer(DTC).
Detailed Description:
This phase 3 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,double-blind,placebo-controlled,study.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind,Placebo-controlled,Phase 3 Trial of Donafenib in 131IRefractory Differentiated Thyroid Cancer
Actual Study Start Date: August 29, 2018
Estimated Primary Completion Date: December 2021
Estimated Study Completion Date: December 2021
Arm:
- Experimental: Donafenib
- Placebo Comparator: Placebo
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 204 |
| Actual Study start date | 29 August 2018 |
| Estimated Study Completion Date | 01 December 2021 |