NCT02614495

Study of Sulfatinib in Treating Advanced Medullary Thyroid Carcinoma and Iodine-refractory Differentiated Thyroid Carcinoma

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Hutchison Medipharma Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thyroid Carcinoma

Interventions

Type	Name	Description
DRUG	Surufatinib	Patients receive oral Sulfatinib at a dose of 300mg/d within 1 hour after breakfast (once-daily dosing continuously, every 28-day treatment cycle)

Timeline

• Start date: 2016-02-24
• Primary completion: 2018-09-30
• Completion: 2018-09-30
• First posted: 2015-11-25
• Last updated: 2020-02-13

Locations

2 sites across 1 country: China