NCT03602495

A Phase 3 Study of Donafenib in Patients With Radioiodine-refractory Differentiated Thyroid Cancer

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Donafenib in Patients With Radioiodine-Refractory Differentiated Thyroid Cancer

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study to compare the progression free survival, overall response rate (ORR) and safety of participants treated with Donafenib 0.3g Bid by continuous oral dosing versus placebo.

Detailed description

Blinded Phase: Participants will receive blinded study drug (Donafenib/placebo) in 2:1 ratio until documentation of disease progression (confirmed by independent imaging review committee), development of unacceptable toxicity, or withdrawal of consent. After having completed the primary analysis, subjects treated with Donafenib who have not experienced disease progression may request to continue open label Donafenib at the same dose, according to the clinical judgment of the investigator. Participants who discontinue treatment for any reason other than disease progression will be followed in the Blinded Phase until disease progression or start of another anticancer treatment; these participants then enter the Open label Phase for survival follow-up. Open label Phase: Participants in the placebo arm who have disease progression confirmed by IRC could request to enter the Optional Open Label Donafenib Treatment Period and receive Donafenib treatment. Participants will receive Donafenib treatment until disease progression, development of intolerable toxicity, or withdrawal of consent. Participants who had disease progression during the blinded Phase and did not enter the Optional Open Label Donafenib Treatment Period and all participants who discontinued Donafenib treatment in the Optional Open Label Donafenib Treatment Period will enter the follow-up period. Participants will be followed for survival, and all anticancer treatments will be recorded until the time of death.

Conditions

• Differentiated Thyroid Cancer

Interventions

Type	Name	Description
DRUG	Donafenib	Donafenib 0.3g Bid orally, continuously. Dose interruptions or reductions were allowed for subjects who experienced treatment-related toxicity.
DRUG	Placebo	Matching placebo Bid orally, continuously.

Timeline

• Start date: 2018-08-29
• Primary completion: 2021-02-28
• Completion: 2021-07-15
• First posted: 2018-07-26
• Last updated: 2021-12-13

Locations

1 site across 1 country: China