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

NCT02614495 | Completed Phase 2

• 1 other identifier: 2015-012-00CH2
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

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).

Conditions

Thyroid Carcinoma

Outcome Measures

Primary Outcomes (1)

• objective response rate (ORR)

  the incidence of confirmed complete response or partial response

  16 months after the last patient enrolled

Secondary Outcomes (4)

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

  From first dose to within 30 days after the last dose

• The disease control rate (DCR)

  16 months after the last patient enrolled

• Progression Free Survival (PFS)

  16 months after the last patient enrolled

• Time to Response (TTR)

  16 months after the last patient enrolled

Study Arms (1)

Surufatinib

EXPERIMENTAL

300mg once-daily

Drug: Surufatinib

Interventions

Surufatinib DRUG

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

Also known as: HMPL-012, Sulfatinib

Surufatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent must be obtained in writing for all subjects before enrollment into the study;
• Age 18 years or older
• 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
• 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
• 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
• At least 6 months of last dose administered prior to study treatment
• 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
• 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
• Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
• Subjects must have measurable lesions meeting the criteria of Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• The expecting life scan was more than 12 weeks
• 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.

You may not qualify if:

• Absolute neutrophil count 1.5×109/L, or platelet\<100 ×109/L, or hemoglobin\< 9g/dL
• Serum bilirubin \>1.5 the upper limit of normal (ULN)
• 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)
• Serum creatinine≥1.5 the upper limit of normal (ULN) , or estimated creatinine clearance \< 60 mL/min
• 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
• 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)
• Serum potassium, calcium (albumin-bound ionic or corrected) or magnesium exceed the normal range with clinical significance
• Active hypertension (systolic pressure≥140mm Hg, or diastolic pressure ≥90mm Hg) that drugs can't control
• 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
• 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
• 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%
• Prolongation of QT interval to≥480 ms
• 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
• 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
• Patients receive palliative irradiation for the bone metastasis within 2 weeks prior to before initial treatment of this study

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead

Study Sites (2)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

surufatinib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: November 25, 2015
• Study Start: February 24, 2016
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: February 13, 2020

Record last verified: 2019-11

Locations

CN (2)