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

Learn more about:
Related Clinical Trial
Radiofrequency Ablation for the Treatment of Benign or Low Risk Thyroid Nodule Optimising Molecular Radionuclide Therapy Selpercatinib Before Surgery for the Treatment of RET-Altered Thyroid Cancer Development of Liquid Biopsy Technologies for Noninvasive Cancer Diagnostics in Patients With Suspicious Thyroid Nodules or Thyroid Cancer Function Integrity of Neck Anatomy in Thyroid Surgery An Investigational Scan (hpMRI) for Monitoring Treatment Response in Patients With Thyroid Cancer Undergoing Radiation Therapy and/or Systemic Therapy Vemurafenib Plus Copanlisib in Radioiodine-Refractory (RAIR) Thyroid Cancers Malignancy Predictors, Bethesda and TI-RADS Scores Correlated With Final Histopathology in Thyroid Diseases Effect of Artificial Tears on Radioiodine Levels in the Nasolacrimal Duct System Evaluation of a New CZT System Thermal Ablation and Spine Stereotactic Radiosurgery in Treating Patients With Spine Metastases at Risk for Compressing the Spinal Cord Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy Cabozantinib S-Malate in Treating Younger Patients With Recurrent or Refractory Solid Tumors Romidepsin in Treating Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Solid Tumors With Liver Dysfunction Modified Cormack Lehane Scores Evaluated by Laryngoscopy During Awake Versus Under General Anesthesia Parathyroid Reimplantation in Forearm Subcutaneous Tissue During Thyroidectomy: a Simple Way to Avoid Ipoparathyroidism and Evaluate Graft Function Efficacy of Fibrin Sealant to Reduce the Amount of Post-thyroidectomy Drain A Study Into the Effect of Seprafilm in Open Total Thyroidectomy Lenvatinib and Pembrolizumab in DTC Study of XL184 (Cabozantinib) in Adults With Advanced Malignancies Genomic Profiling of Nodular Thyroid Disease and Thyroid Cancer Comparative Study of Robot BABA Approach and Chest Breast Approach for Lateral Neck Dissection Sunitinib Malate in Treating Patients With Thyroid Cancer That Did Not Respond to Iodine I 131 and Cannot Be Removed by Surgery Cabozantinib-S-Malate in Treating Patients With Refractory Thyroid Cancer Iodine I-131 With or Without Selumetinib in Treating Patients With Recurrent or Metastatic Thyroid Cancer Trametinib in Increasing Tumoral Iodine Incorporation in Patients With Recurrent or Metastatic Thyroid Cancer Influence of Thyroid Hormones on the Woundhealing Process ctDNA in Patients With Thyroid Nodules Selumetinib in Treating Patients With Papillary Thyroid Cancer That Did Not Respond to Radioactive Iodine Aflibercept in Treating Patients With Recurrent and/or Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy Radioiodine Dosimetry Protocol for Thyroid Cancer Metastases Evaluation of Lancet Blood Sampling for Radioiodine Dosimetry in Thyroid Cancer Pazopanib Hydrochloride in Treating Patients With Advanced Thyroid Cancer Clinical Evaluation of 18F-DOPA Positron Emission Tomography in Medullary Thyroid Cancer Biomarkers to Distinguish Benign From Malignant Thyroid Neoplasm Gallium-68 Prostate Specific Membrane Antigen PET in Diagnosing Patients With Thyroid Cancer Effect of Polyglycolic Acid Mesh (Neoveil) in Thyroid Cancer Surgery The Effect of Coffee on the Absorption of Thyroid Hormone in Patients With Thyroid Carcinoma Lesion Dosimetry With Iodine-124 in Metastatic Thyroid Carcinoma Renal Tracer Elimination in Thyroid Cancer Patients Treated With 131-Iodine Trial of LBH589 in Metastatic Thyroid Cancer Enhancing Radioiodine (RAI) Incorporation Into BRAF Mutant, RAI-Refractory Thyroid Cancers With the BRAF Inhibitor Vemurafenib: A Pilot Study Prospective, Non-interventional, Post-authorization Safety Study That Includes All Patients Diagnosed as Unresectable Differentiated Thyroid Carcinoma and Treated With Sorafenib Phase II Study of the Optimal Scheme of Administration of Pazopanib in Thyroid Carcinoma Study of Sulfatinib in Treating Advanced Medullary Thyroid Carcinoma and Iodine-refractory Differentiated Thyroid Carcinoma Thyroid Cancer and Sunitinib Feasibility of Endoscopic Thyroidectomy for Thyroid Carcinoma Sorafenib Phase II Study for Japanese Anaplastic or Medullary Thyroid Carcinoma Patients Lipid Metabolic Status in Thyroid Carcinoma

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

Interventional


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

Condition

Thyroid Carcinoma

Intervention

Surufatinib

Study Arms / Comparison Groups

 Surufatinib
Description:  300mg once-daily

Publications

* 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

Drug

Estimated Enrollment

66

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
             0-1

         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
             years

         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
             infection

         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
             healed

         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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT02614495

Organization ID

2015-012-00CH2


Responsible Party

Sponsor

Study Sponsor

Hutchison Medipharma Limited


Study Sponsor

, , 


Verification Date

November 2019