Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2026-03-03 @ 2:21 AM
Study NCT ID:
NCT02614495
Status:
COMPLETED
Last Update Posted:
2020-02-13
First Post:
2015-11-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Sulfatinib in Treating Advanced Medullary Thyroid Carcinoma and Iodine-refractory Differentiated Thyroid Carcinoma
Sponsor:
Hutchison Medipharma Limited
Organization:
Study Overview
Official Title:
A Multi-center , Opened, Phase II Study of Safety and Efficacy of Sulfatinib in Advanced Medullary Thyroid Carcinoma ( MTC) and Iodine-refractory Differentiated Thyroid Carcinoma (DTC)
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A multi-center , opened, Phase II study to assess the efficacy and safety of Sulfatinib 300 mg Sulfatinib in advanced Medullary Thyroid Carcinoma ( MTC) and iodine-refractory differentiated thyroid carcinoma (DTC).
Detailed Description:
This study adopt Simon's two-stage designs method. In the first stage, When the first 12 patients enrolled complete therapy of Cycle 1, investigators and sponsors will analyze safety and pharmacokinetic (PK) data, to determine whether the dose is suitable for TC and enrollment should be stopped during this period.15 subjects will be enrolled in both subgroups (advanced MTC and iodine-refractory DTC), and more 10 subjects in each subgroups will be enrolled after efficacy assessment in the second stage.
Patients receive oral sulfatinib at a dose of 300mg/d within 1 hour after breakfast (once-daily dosing continuously, every 28-day treatment cycle) until disease progression, death, or intolerable toxicity, or in the opinion of the investigator, patients were no longer deriving clinical benefit、lost to follow-up、withdrew informed consent form, or sponsors terminated the study, whichever comes first.
Patients receive oral sulfatinib at a dose of 300mg/d within 1 hour after breakfast (once-daily dosing continuously, every 28-day treatment cycle) until disease progression, death, or intolerable toxicity, or in the opinion of the investigator, patients were no longer deriving clinical benefit、lost to follow-up、withdrew informed consent form, or sponsors terminated the study, whichever comes first.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: