Study of Sulfatinib in Treating Advanced Medullary Thyroid Carcinoma and Iodine-refractory Differentiated Thyroid Carcinoma
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|ClinicalTrials.gov Identifier: NCT02614495|
Recruitment Status : Completed
First Posted : November 25, 2015
Last Update Posted : February 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Carcinoma||Drug: Surufatinib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||February 24, 2016|
|Actual Primary Completion Date :||September 30, 2018|
|Actual Study Completion Date :||September 30, 2018|
Patients receive oral Sulfatinib at a dose of 300mg/d within 1 hour after breakfast (once-daily dosing continuously, every 28-day treatment cycle)
- objective response rate (ORR) [ Time Frame: 16 months after the last patient enrolled ]the incidence of confirmed complete response or partial response
- Adverse events evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 [ Time Frame: From first dose to within 30 days after the last dose ]The safety and tolerability of sulfatinib will be evaluated based on adverse events data. Other safety parameters include physical examination, vital signs, laboratory test results (i.e., hematology, chemistry panel, and urinalysis), 12-lead electrocardiogram, and ultrasonic cardiogram
- The disease control rate (DCR) [ Time Frame: 16 months after the last patient enrolled ]the incidence of complete response, partial response and stable disease
- Progression Free Survival (PFS) [ Time Frame: 16 months after the last patient enrolled ]the duration between the randomization date and the first disease progression (PD) or death (whichever comes first).
- Time to Response (TTR) [ Time Frame: 16 months after the last patient enrolled ]the period from the date of randomization to the date when the criteria for complete response or partial response was first measured (first record shall prevail).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02614495
|Peking Union Medical College Hospital|
|Beijing, Beijing, China, 100032|
|Fudan University Shanghai Cancer Center|
|Shanghai, Shanghai, China, 200032|