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

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Brief Title

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

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)

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.

Study Phase

Phase 2

Study Type


Primary Outcome

objective response rate (ORR)

Secondary Outcome

 Adverse events evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03


Thyroid Carcinoma



Study Arms / Comparison Groups

Description:  300mg once-daily


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

February 24, 2016

Completion Date

September 30, 2018

Primary Completion Date

September 30, 2018

Eligibility Criteria

        Inclusion Criteria:

          1. Informed consent must be obtained in writing for all subjects before enrollment into
             the study;

          2. Age 18 years or older

          3. Subjects must have histologically or cytologically confirmed diagnosis of locally
             advanced and/ or metastatic MTC or iodine-refractory DTC (papillary, follicular ,
             Hürthle cell and other variable type carcinoma), losing the surgical indications or
             can't undertake external radiotherapy

          4. Subjects must show evidence of disease progression within 12 months (assessed and
             confirmed by central radiographic review of CT and/or MRI scans) before initial
             treatment of this study

          5. Subjects must be I-refractory / resistant as defined by at least one of the following:
             One or more measurable lesions that has progressed by CT and/or MRI scans within 12
             months of Iodine-131 (131I) therapy; One or more measurable lesions that do not
             demonstrate 131I uptake on any radioiodine scan ; Cumulative activity of 131I of > 600
             millicurie or 22 gigabecquerel (GBS), and independently reviewed radiologic evidence
             of progression within the previous 12 months before initial treatment of this study

          6. At least 6 months of last dose administered prior to study treatment

          7. Subjects may have received 0 or 1 prior vascular endothelial growth factor
             (VEGF)/VEGFR-targeted therapy (for example , patients with MTC have received
             vandetanib or cabozantinib; patients with DTC have received sorafenib or lenvatinib)
             or other targeted inhibitors

          8. Subjects with DTC, serum thyroid-stimulating hormone (TSH) concentration should be
             lower than 0.1 milliunits per litre (mU/L) (or other corresponding units) before
             enrollment into the study; Subjects with MTC, levels of serum TSH concentration should
             be in the normal range

          9. Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of

         10. Subjects must have measurable lesions meeting the criteria of Response Evaluation
             Criteria in Solid Tumors (RECIST) 1.1

         11. The expecting life scan was more than 12 weeks

         12. Females or Males of childbearing potential must agree to use a highly effective method
             of contraception (e.g., a double-barrier method, condom, a injective or oral
             contraceptive, an intrauterine device) throughout the entire study period and for 90
             days after study drug discontinuation. All females will be considered to be of
             childbearing potential unless they are postmenopausal.

        Exclusion Criteria:

          1. Absolute neutrophil count 1.5×109/L, or platelet<100 ×109/L, or hemoglobin< 9g/dL

          2. Serum bilirubin >1.5 the upper limit of normal (ULN)

          3. Serum alanine transaminase (ALT) , aspartate aminotransferase (AST) or Alkaline
             phosphatase (ALP) ≥2.5 ULN (Patients with documented disease infiltration of the liver
             may have ALT, AST or ALP levels ≥ 5 the ULN)

          4. Serum creatinine≥1.5 the upper limit of normal (ULN) , or estimated creatinine
             clearance < 60 mL/min

          5. Subjects having≥2+ proteinuria on urine dipstick testing will undergo 24h urine
             collection for quantitative assessment of proteinuria. Subjects with urine
             protein≥1g/24 h will be ineligible

          6. International normalized ratio (INR) ≥1.5 the ULN or activated partial thromboplastin
             time (aPTT) ≥1.5 the ULN (For patients requiring anticoagulation therapy with
             warfarin, a stable INR between 2-3 is required)

          7. Serum potassium, calcium (albumin-bound ionic or corrected) or magnesium exceed the
             normal range with clinical significance

          8. Active hypertension (systolic pressure≥140mm Hg, or diastolic pressure ≥90mm Hg) that
             drugs can't control

          9. Gastrointestinal disease or condition that investigators suspect may affect drug
             absorption, including but not limited to, previously subtotal gastrectomy surgery,
             active gastric and duodenal ulcers, ulcerative colitis and other digestive disease,
             gastrointestinal tumor with active bleeding, or other gastrointestinal conditions that
             may cause bleeding or perforation by investigator's discretion

         10. History or presence of a serious hemorrhage (>30 ml within 3 months), hemoptysis (>5
             ml blood within 4 weeks) or a thromboembolic event (including transient ischemic
             attack) within 12 months

         11. Clinically significant cardiovascular disease, including but not limited to, acute
             myocardial infarction within 6 months prior to enrollment, severe/unstable angina
             pectoris or coronary artery bypass grafting, congestive heart failure according to the
             New York Heart Association (NYHA) classification ≥ 2; ventricular arrhythmias which
             needs drug treatment; LVEF (LVEF) <50%

         12. Prolongation of QT interval to≥480 ms

         13. Active malignancy (except for definitively treated melanoma in-situ, basal or squamous
             cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 5

         14. Patients were excluded from the study if they had received anti-tumor therapies,
             including but not related to chemotherapy, radial radiation therapy, biological
             therapy, immunotherapy, or treatment with herb product within 4 weeks prior to initial
             treatment of this study. TSH suppression therapy is not included

         15. Patients receive palliative irradiation for the bone metastasis within 2 weeks prior
             to before initial treatment of this study

         16. Patients receive cytochrome P450 3A4 (CYP3A4) strong inducer or inhibitors (as seen in
             attachment 3) within 2 weeks (3 weeks for Hypericum perforatum) prior to initial
             treatment of this study

         17. Clinically significant and active infection, including but not limited to HIV

         18. Clinically significant history of liver disease, including virus hepatitis [known HBV
             carrier, active hepatitis B virus (HBV) infection (>1*104/ml) must be excluded; known
             hepatitis C virus (HCV) carrier, active HCV infection (>1*103/ml) must be excluded]
             and other hepatitis, cirrhosis

         19. Major surgery within 4 weeks prior to enrollment, or the incision is still not fully

         20. Subjects with known brain metastases or spinal cord compression who have not completed
             radiosurgery or surgical resection, or who have previously treated but with no
             clinical imaging evidence of disease stability

         21. Subjects has not recovered from any toxicity related to previous anticancer treatment
             to level 0 or 1 (alopecia excluded)

         22. Subjects who have received any investigational agent within 4 weeks prior to the first
             dose of study drug

         23. Pregnancy (test is positive before the first dose of study drug) or any other
             lactating women

         24. Any other diseases, metabolic dysfunction, physical examination finding, or clinical
             laboratory finding that, in the investigator's opinion, gives reasonable suspicion of
             a disease or condition that contraindicates the use of an investigational drug or that
             may affect the interpretation of the results or renders the patient at high risk from
             treatment complications.




18 Years - N/A

Accepts Healthy Volunteers



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Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party


Study Sponsor

Hutchison Medipharma Limited

Study Sponsor

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Verification Date

November 2019