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Thyroid CarcinomaPhase 2NCT02614495

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

A Phase 2 study testing Surufatinib in people with Thyroid Carcinoma, run by Hutchison Medipharma Limited at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Carcinoma
What is being tested?
Surufatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
2 sitesChina
Study dates
24 Feb 2016to 30 Sep 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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)
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  • 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
  • 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
  • Clinically significant and active infection, including but not limited to HIV infection
  • 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
  • Major surgery within 4 weeks prior to enrollment, or the incision is still not fully healed
  • 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
  • Subjects has not recovered from any toxicity related to previous anticancer treatment to level 0 or 1 (alopecia excluded)
  • Subjects who have received any investigational agent within 4 weeks prior to the first dose of study drug
  • Pregnancy (test is positive before the first dose of study drug) or any other lactating women
  • 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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100032

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

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)

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).

Read the 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.

Being tested
Surufatinib
Medical subject headings
Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurufatinibDrug

    Also called HMPL-012, Sulfatinib

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

Study groups in NCT02614495
Study groupRoleWhat they receive
SurufatinibExperimental300mg once-daily
Receives: Drug: Surufatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. objective response rate (ORR)

    the incidence of confirmed complete response or partial response

    Measured: 16 months after the last patient enrolled

Secondary outcomes (4)

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

    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

    Measured: From first dose to within 30 days after the last dose

  2. The disease control rate (DCR)

    the incidence of complete response, partial response and stable disease

    Measured: 16 months after the last patient enrolled

  3. Progression Free Survival (PFS)

    the duration between the randomization date and the first disease progression (PD) or death (whichever comes first).

    Measured: 16 months after the last patient enrolled

  4. Time to Response (TTR)

    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).

    Measured: 16 months after the last patient enrolled

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2015 (estimated)
  2. Study start24 Feb 2016
  3. Primary completion30 Sep 2018
  4. Study completion30 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02614495
Sponsor's protocol ID
2015-012-00CH2
Status last verified
Nov 2019
First submitted
24 Nov 2015
Last updated
13 Feb 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Surufatinib in people with Thyroid Carcinoma, run by Hutchison Medipharma Limited at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

objective response rate (ORR) (time frame: 16 months after the last patient enrolled). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02614495.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.

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