Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-27 @ 10:03 PM
Study NCT ID:
NCT03602495
Status:
TERMINATED
Last Update Posted:
2021-12-13
First Post:
2018-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 3 Study of Donafenib in Patients With Radioiodine-refractory Differentiated Thyroid Cancer
Sponsor:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Donafenib in Patients With Radioiodine-Refractory Differentiated Thyroid Cancer
Status:
TERMINATED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Based on IDMC's recommendations during the interim analysis"the trial has reached the goal of early termination of the trial". the sponsor communicating with CDE, CDE agreed to unblind the trial and submit a NDA.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DTC
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: