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A Clinical Study of Apatinib in Patients With Local Progressive/Metastatic Refractory Thyroid Cancer

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ClinicalTrials.gov Identifier: NCT03199677
Recruitment Status : Unknown
Verified June 2017 by Shengyu Zhou, Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : June 27, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Shengyu Zhou, Chinese Academy of Medical Sciences

Brief Summary:
This is a single-center, open-label, single arm,exploratory clinical trial evaluating the efficacy and safety of Apatinib in patients with local progressive/metastatic refractory thyroid cancer.

Condition or disease Intervention/treatment Phase
Refractory Cancer Drug: Apatinib Phase 2

Detailed Description:

This is a single-center, open-label, single arm,exploratory clinical trial evaluating the efficacy and safety of Apatinib in patients with local progressive/metastatic refractory thyroid cancer.

The primary endpoint is objective response rate(ORR),the secondary endpoints include progression-free-survival(PFS);disease control rate(DCR);serum Tg、TgAb、calcitonin;safety.

If any case happens as following,including withdrawing informed consent form(ICF)、unbearable toxicity or adverse reactions、other conditions which investigators think the patients are unsuitable to go on trail,the patient will not go on trial any longer,or every subject will obtain study treatment until tumor progress with CT/MRI proof.The indicators of efficacy and safety will be always observed during the trail process.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: single group,apatinib 500mg po qd,d1-28
Masking: None (Open Label)
Masking Description: no parallel,no control
Primary Purpose: Treatment
Official Title: An Exploratory Single-center, Open-label , Clinical Study of Apatinib in Patients With Local Progressive/Metastatic Refractory Thyroid Cancer
Estimated Study Start Date : July 1, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Arm Intervention/treatment
Experimental: apatinib with 500mg qd po
Patients administrate apatinib with the dose of 500mg once per day,half an hour after a meal.
Drug: Apatinib
Apatinib is an oral tyrosine kinase inhibitor.




Primary Outcome Measures :
  1. objective response rate [ Time Frame: 1 year ]
    ORR is defined as the percentage of subjects having achieved confirmed Complete Response+Partial Response as best overall response according to Response Evaluation Criteria Solid Tumors(RECIST 1.1).


Secondary Outcome Measures :
  1. progression-free-survival(PFS) [ Time Frame: 1 year ]
    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.

  2. disease control rate(DCR) [ Time Frame: 1 year ]
    Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1(RECIST1.1).

  3. serum Tg、TgAb、calcitonin [ Time Frame: 1 year ]
    Evaluating the change of serum level of Tg,TgAb or calcitonin,assessed up to 12 months.

  4. Adverse Events(AEs) [ Time Frame: 1 year ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ≥18 years old,gender limitation.
  2. The pathologic subtype of thyroid carcinoma, which was confirmed by histopathological histology, included iodine refractory thyroid papillary carcinoma and follicular carcinoma, medullary thyroid carcinoma and undifferentiated carcinoma.
  3. Patients with at least one measurable lesion (RECIST1.1), at least one measurable lesion after the treatment (spiral CT scan length to diameter 10 mm or higher, according with the requirement of RESCIST version 1.1 standard).
  4. Radioactive iodine deficiency (according with one of the following conditions):

    1. The target lesion was completely deprived of iodine in the treatment of radioactive iodine;
    2. The patients were treated with single dose of iodine (3.7 GBq) and the disease progressed in 12 months;
    3. The patients were given an iodine treatment interval of less than 12 months, and the dose was greater than that 3.7 GBq [≥100mCi], with at least one iodine treatment over 12 months of disease progression;
    4. Cumulative doses of radioactive iodine were greater than 22.2 GBq (or more than 600 mCi).
  5. Patients who underwent at least one failure of standard chemotherapy can be recommended to get into the group.
  6. Organs function have to be compliant with the following specifications:

    ANC≥1.5×109/L; PLT≥100×109/L; Hb≥90g/L; TBIL≤1.5×ULN; ALT &AST ≤2.5×ULN ; ALT &AST ≤5×ULN in patients with hepatic metastasis; BUN & Cr≤1×ULN, CCR≥50mL/min (Cockcroft-Gault formula); Normal coagulation function (INR<1.5 or PT<ULN+4s or APTT<1.5 ULN); Urinary protein<++ or urine protein quantitation in 24 hours ≤1.0 g.

  7. Life expectancy ≥ 12 weeks.
  8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0~2.
  9. Pre-menopausal women must have a negative pregnancy test within 7 days before study entry and agree to use a medically acceptable method of contraception throughout the treatment periods and for at least six weeks after treatment discontinuation.
  10. The subjects volunteered to participate in the study, sign informed consent forms, and compliance with follow-up.

Exclusion Criteria:

  1. The presence of a third interstitial fluid (such as a large amount of pleural effusion and/or peritoneal fluid, pericardial fluid) that cannot be controlled by a drainage or other methods.
  2. Before or at the same time with other malignant tumors, except cured skin basal cell carcinoma, cervical carcinoma in situ or other effective treatment of tumors and did not see signs of disease for five years.
  3. The patients who used VEGFR-TKI drugs, such as Vandetanib, Cabozantinib, Lenvatinib,Sunitinib,Sorafenib in one month.
  4. Inability to swallow, chronic diarrhea and obstruction of the intestine, various factors which affect drug use and absorption.
  5. major surgical or severe trauma injuries, fractures, or ulcers before 4 weeks of enrolling , 3 weeks of radiation therapy (except for partial palliative radiation), chemotherapy, and molecular target therapy in three weeks, Treatment with nitrocarbamide or mitomycin before six weeks of enrolling.
  6. uncontrolled hypertension (systolic blood pressure of 140mmHg or diastolic pressure is greater than 90mmHg, despite the best drug treatment).
  7. Patients used to suffer from severe cardiovascular diseases: Ⅱ magnitude of myocardial ischemia and myocardial infarction, poor control of cardiac arrhythmias (including QTc interphase male ≥450ms, female≥470ms); According to NYHA standard, Ⅲ ~ Ⅳ cardiac insufficiency, or heart color indicate left ventricular ejection fraction (LVEF) < 50%.
  8. History of significant hemoptysis within 2 months prior to enrollment or daily hemoptysis is up to 2.5ml;with the trend of haemorrhage or prior treatment with an angiogenesis therapy.
  9. Significant clinical significance of bleeding symptoms or a definite bleeding tendency happened in three months prior to screening, such as gastrointestinal bleeding, bleeding ulcers, baseline period + + and above of defecate occult blood, or those with vasculitis, etc.
  10. Active brain metastasis, cancer meningitis, Spinal cord oppressor activity of brain metastases of, cancer, spinal cord compression patients, CT or MRI examination revealed brain or soft meningeal disease (patients who completed treatment and get stable symptoms with brain metastases can be into the group in 21 days prior to screening, without symptoms of cerebral hemorrhage).
  11. Imaging (CT or MRI) showed that tumor lesions were less than 5mm from the large blood vessels, or the central type of tumor that had penetrated the large blood vessels, or there is a clear pulmonary void or necrotic tumor.
  12. Patients accept other anti-tumor therapies at the same time.
  13. Treatment of thyroid cancer radiation was received 28 days prior to screening.
  14. Participated in other clinical trials within 4 weeks.
  15. Active or chronic hepatitis c and/or hepatitis b infection and other active infections (determined by the investigators).
  16. History of immunodeficiency disease, including human immunodeficiency virus infect(HIV), or acquired immunodeficiency disease (AID) and Congenital immunodeficiency disease, or history of organs for transplantation.
  17. Abdominal fistula, digestive tract perforation or intra-abdominal abscess happened within six months prior to screening.
  18. Within 12 months before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack (TIA), hematencephalon, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc. Received a powerful CYP3A4 inhibitor treatment in the first 7 days before the group, or received a powerful CYP3A4 inducer in the first 12 days before the study.
  19. According to the investigator's judgment, there is serious illness to endanger the safety of patients, the completion of the study (e.g: severe diabetes, renal insufficiency).
  20. A history of specific neurological or psychiatric disorders, including epilepsy or dementia.
  21. Other cases that the investigator found ineligible.

Information from the National Library of Medicine

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): NCT03199677


Contacts
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Contact: Shengyu Zhou, professor 13520852899 typhoonwho@126.com
Contact: Hongzhe Wang, doctor 18911052235 aiesecarrow@163.com

Locations
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China, Beijing
Cancer Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100021
Contact: Dawei Wu, professor    13521689314    cancergcp@163.com   
Principal Investigator: Shengyu Zhou, professor         
Sponsors and Collaborators
Chinese Academy of Medical Sciences

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Responsible Party: Shengyu Zhou, Deputy director of the physician, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03199677     History of Changes
Other Study ID Numbers: AHEAD-RTC001
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Shengyu Zhou, Chinese Academy of Medical Sciences:
apatinib,refractory thyroid cancer
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action