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Trial record 4 of 6 for:    Apatinib | thyroid cancer

Phase 2 Trial of Apatinib Mesylate in Locally Advanced/Metastatic Differentiated Thyroid Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03167385
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

Brief Summary:
This is a non-randomized, phase II, open label study of Apatinib Mesylate in patients with with locally advanced or metastatic differentiated thyroid carcinoma (DTC). The purpose of this study is to evaluate the efficacy and safety of apatinib in patients with locally advanced or metastatic differentiated thyroid carcinoma.

Condition or disease Intervention/treatment Phase
Differentiated Thyroid Carcinoma Drug: Apatinib Mesylate Phase 2

Detailed Description:
At present, multiple anti-angiogenesis drugs for thyroid cancer of clinical research are ongoing worldwide, and most of which achieved fairly good therapeutic effect. To date, sorafenib has been approved for the treatment of radioactive iodine refractory DTC. Apatinib is a highly selective VEGFR2 inhibitor that reduces the angiogenesis of tumor efficiently, and had been proven to be effective in many solid tumors. In this study, the investigators aim to further explore the efficacy and safety of apatinib in locally advanced or metastatic differentiated thyroid carcinoma.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effectiveness and Safety of Apatinib Mesylate in Locally Advanced/Metastatic Differentiated Thyroid Carcinoma: a Phase 2 Trial.
Actual Study Start Date : March 22, 2017
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Arm Intervention/treatment
Experimental: Experitmental
Continuous oral intake of Apatinib Mesylate (500mg), once a day, until progression of disease or severe adverse effect.
Drug: Apatinib Mesylate
oral intake of Apatinib Mesylate 500mg once a day until progression of diesase or severe adverse effect
Other Name: YN968D1




Primary Outcome Measures :
  1. disease control rate [ Time Frame: within two weeks of drug administration ]
    percentage of patients who have achieved complete response, partial response and stable disease to overall therapeutic intervention patients


Secondary Outcome Measures :
  1. progression free survival [ Time Frame: 2 years ]
    time that passes from the day the participants received the apatinib and the date on which disease progresses or the date on which the patient dies, from any cause.

  2. overall survival [ Time Frame: 2 years ]
    percentage of patients who are alive after a certain time period after they were treated

  3. objective response rate [ Time Frame: 2 weeks ]
    percentage of patients who have achieved complete response and partial response to overall therapeutic intervention patients



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. Informed consent.
  2. Histopathology confirmed locally advanced or metastatic differentiated thyroid carcinoma, with measurable lesions (RECIST 1.1).
  3. Age:18-75 years, ECOG(Eastern Cooperative Oncology Group) Score:0-2, Expected survival period ≥ 3 months.
  4. Patients with disease progression which was confirmed by imaging in 18 months, and meet any one of the following four:

    1. The tumor invades important organs, and cannot be resectted completely, the remnant thyroid tissue is extensive and not suitable for further iodine treatment.
    2. Lesions have no iodine affinity.
    3. The cumulative dose of RAI (radioactive iodine) ≥ 600mCi or 22GBq.
    4. Patients with disease progression confirmed by radiological examination within 18 months of last RAI.
  5. Patients general condition meeting the following:

    Haemoglobin (HBG) ≥ 90 g/L, neutrophil count (ANC) ≥ 1.5×109/L, platelet count (PLT) ≥ 80×109/L, total bilirubin (TBIL)< 1.5×ULN (upper limit of normal), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5×ULN (ALT and AST < 5×ULN if have liver metastasis), SCr (serum creatinine) <1.5×ULN, left ventricular ejection fraction ≥ 50% of normal.

  6. Past history of less than one kind of tyrosine kinase inhibitor.
  7. Pregnancy test (serum or urine) has to be performed in woman of childbearing age within 7 days before enrolment and the test result must be negative. Patients enrolled should take appropriate contraceptive measures during the study until the 6th month post the last administration of study drug. For male participants, (previous surgical sterilization accepted), agreement to take appropriate methods of contraception during the study until the 6th month post the last administration of study drug is required.

Exclusion Criteria:

  1. Patients with past apatinib treatment or have received two or more small molecular TKI (Tyrosine Kinase Inhibitor) drugs.
  2. Patients accepted external beam radiation therapy or iodine - 131 therapy in recent three months, or patients plan to receive the other systemic anti-tumor treatment during the study.
  3. Patient with history of another malignant disease within past 5 years, cervical carcinoma in situ, non melanoma skin cancer and superficial bladder tumor are spared.
  4. Patients without unrelieved toxicity reaction above CTCAE grade, neurotoxicity and hair loss due to oxaliplatin are spared.
  5. Preconditions that impair successful oral medication intake (such as inability to swallow, chronic diarrhea).
  6. Patients with pleural effusion or ascites that lead to respiratory syndrome (above CTCAE grade 2).
  7. Patients with severe systemic diseases that might impair cardiac function, et al.
  8. Patients accepted major surgery、incision biopsy or obvious traumatic injury in 28 days before the study.
  9. Patients with physical signs or medical history of bleeding.
  10. Patients with thromboembolism event in 6 months.
  11. Patients with history of aneurysm.
  12. Patients with epilepsy which needs medication.
  13. Patients with history of psychiatric drug abuse or have a mental disorder.
  14. Patients with history of disease in peripheral nervous system, muscle strength under level 3.
  15. Attended other antitumor drug clinical trials or other ongoing clinical subjects within 4 weeks.
  16. According to the researcher's judgment, there is other possible serious condition that endanger the safety of patients.

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): NCT03167385


Contacts
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Contact: Ming Gao, MD 862223340123 ext 3150 gaoming@tjmuch.com
Contact: Xiangqian Zheng, MD 862223340123 ext 3150 xiangqian_zheng@163.com

Locations
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China, Tianjin
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: Xiangqian Zheng, MD         
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Investigators
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Study Chair: Ming Gao, MD Tianjin Medical University Cancer Institute and Hospital
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Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT03167385    
Other Study ID Numbers: AHEAD-HBT001
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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 Tianjin Medical University Cancer Institute and Hospital:
locally advanced differentiated thyroid carcinoma
radioiodine refractory thyroid carcinoma
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Apatinib
Carcinoma
Endocrine System Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action