Thyroid Carcinoma Clinical Trial
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)
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).
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.
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