Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 6 for:    Apatinib | thyroid cancer

Efficacy of Apatinib in Radioactive Iodine-refractory Differentiated Thyroid Cancer

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: NCT03048877
Recruitment Status : Recruiting
First Posted : February 9, 2017
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Yansong Lin, Peking Union Medical College Hospital

Brief Summary:
Radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC) is a great challenge in the treatment of thyroid cancer. Tyrosine kinase inhibitors (TKIs), like sorafenib and lenvatinib which have been approved by food and drug administration (FDA), could not be affordable for most of the Chinese patients. Apatinib is a highly selective VEGFR2 inhibitor and reduces the angiogenesis of tumor efficiently, which had been proven effective in many solid tumors, is a Chinese domestic TKI targeting vascular endothelial growth factor receptor (VEGFR). A phase II study aims to assess the efficacy and safety of apatinib in RAIR-DTC was enrolled 20 patients, and 10 of them had obtained a shout-term efficacy,the study demonstrate the peculiar potential in treatment of RAIR-DTC. In this study, the investigators aim to further explore the efficacy and safety of apatinib in RAIR-DTC.

Condition or disease Intervention/treatment Phase
Differentiated Thyroid Cancer Drug: Apatinib Oral Tablet Drug: Placebo Oral Tablet Phase 3

Detailed Description:

Primary Outcome Measure: Progression free survival of apatinib RAIR-DTC.

Secondary Outcome Measures: Disease control rate, objective response rate, duration of response, changes of Tg and TgAb level in serum, overall survival, side effects and quality of life.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, Double-Blind, Placebo-Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Apatinib in Locally Advanced or Metastatic Radioactive Iodine-refractory Differentiated Thyroid Cancer
Actual Study Start Date : December 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Apatinib
Apatinib Mesylate Tablets
Drug: Apatinib Oral Tablet
Apatinib Mesylate Tablets

Placebo Comparator: Placebo
Placebo Tablets
Drug: Placebo Oral Tablet
Placebo Oral Tablet




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Disease control rate [ Time Frame: 24 months ]
  2. Objective response rate [ Time Frame: 24 months ]
  3. Duration of response [ Time Frame: 24 months ]
  4. Changing trend of Tg and TgAb level in serum [ Time Frame: 24 months ]
    Monitor the changes of Tg and TgAb level in serum regularly ( every 2~8 weeks, and addition examinations were needed if the participants' condition changed ) and draw the relevant changing curve to monitor the change of disease.

  5. Overall survival [ Time Frame: 24 months ]
  6. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 24 months ]
    Record the number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  7. Quality of life [ Time Frame: 24 months ]
    EQ-5D



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged after 18 years (18 is included).
  2. Locally advanced or metastatic differentiated thyroid cancer (papillary, follicular, Hurthle cells, poorly differentiated carcinoma). At least one measurable lesion (helical CT scan long diameter ≥10mm, meet the requirements of the standard Response Evaluation Criteria In Solid Tumors(RESCIST) version 1.1).
  3. Disease progression within 12 months before inclusion.
  4. Subjects must be 131I-refractory / resistant as defined by at least one of the following;

    • Lesions that do not demonstrate iodine uptake on any radioiodine scan;
    • Subjects received a single radioactive iodine therapy within 12 months (≥ 3.7 Giga Bequerel(GBq)[≥ 100 millicurie(mCi)]) and target lesion disease progression;
    • Every two radioactive iodine treatment interval <12 months, doses ≥ 3.7 GBq [≥100mCi], disease progress more than 12 months after at least once iodine therapy;
    • Received a total dose of radioactive iodine therapy ≥ 22.2 GBq (≥ 600 mCi);
  5. Normal main organ function:

    • HB ≥ 90g / L;
    • ANC ≥1.5×109/L;
    • PLT ≥80×109/L;
    • BIL <1.5 × ULN;
    • ALT and AST <2.5 × ULN;
    • Cr≤1×ULN;
  6. Eastern Cooperative Oncology Group(ECOG)Performance Status(PS) :0-2.
  7. An expected survival of ≥ 3 months.
  8. Pregnancy test (serum) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. They shall take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men, (previous surgical sterilization accepted), shall agree to take appropriate methods of contraception during the study until the 8th week post the last administration of study drug.
  9. Patient has to voluntarily join the study and sign the Informed Consent Form for the study.
  10. Good compliance is expected, according to the program requirements follow-up and recorded adverse reactions.

Exclusion Criteria:

  1. Other thyroid cancer histological subtypes (such as medullary carcinoma, lymphoma or sarcoma).
  2. Received VEGFR inhibitor (such as vandetanib, cabozantinib, lenvatinib, sunitinib, sorafenib, etc.) treatment within 1 months.
  3. Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management; coronary heart disease greater than Class II; II-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class II cardiac dysfunction.
  4. Factors that could have an effect on oral medication (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction).
  5. Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 3 months.
  6. Abnormal Coagulation (INR>1.5、APTT>1.5 UNL), with tendency of bleed.
  7. Disposition evidence of thrombosis/bleeding in 2 month (despite severity), hemoptysis in 2 months (bright red blood, 1/2 teaspoon).
  8. Arterial /venous thromboembolic events, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism in the past 12 months.
  9. Factors that could received radiotherapy or major surgery for anti - thyroid cancer in the past 28 days.
  10. Factors that could received surgery (allows the full-recovery wound) or active hemorrhage, ulceration, intestinal perforation or intestinal obstruction in the past 28 days.
  11. Uncontrolled infection.
  12. Pregnant or lactating women.
  13. Disposition evidence of depressive disorder (HAMD score ≥17).
  14. Other conditions regimented at investigators' discretion.

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): NCT03048877


Contacts
Layout table for location contacts
Contact: Yansong Lin, Prof. M.D. +86-10-69155610 linys@pumch.cn
Contact: Shukui Qin, Prof. M.D.

Locations
Layout table for location information
China, Jiangsu
Nanjing PLA 81 Hospital Recruiting
Nanjing, Jiangsu, China
Contact: Shukui Qin, Prof. M.D.    +86-26-84453932    qinsk@csco.org.cn   
China
Peking Union Medical College Hospital Recruiting
Peking, China, 100730
Contact: Lin Yansong, MD    +86-10-69155610    linys@pumch.cn   
Sponsors and Collaborators
Peking Union Medical College Hospital

Layout table for additonal information
Responsible Party: Yansong Lin, Prof. M.D., Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03048877    
Other Study ID Numbers: PUMCH-NPLA81H-Ahead-T302
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yansong Lin, Peking Union Medical College Hospital:
Radioactive iodine-refractory
differentiated thyroid cancer
Apatinib
anti-angiogenesis drugs
Additional relevant MeSH terms:
Layout table for MeSH terms
Thyroid Neoplasms
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Apatinib
Endocrine System Diseases
Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action