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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03048877
Recruitment Status : Active, not recruiting
First Posted : February 9, 2017
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Yansong Lin, Peking Union Medical College Hospital

Tracking Information
First Submitted Date  ICMJE February 3, 2017
First Posted Date  ICMJE February 9, 2017
Last Update Posted Date May 8, 2020
Actual Study Start Date  ICMJE December 2016
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2020)
PFS [ Time Frame: 24 months ]
Progression free survival
Original Primary Outcome Measures  ICMJE
 (submitted: February 7, 2017)
Progression free survival [ Time Frame: 24 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2020)
  • DCR [ Time Frame: 24 months ]
    Disease control rate
  • ORR [ Time Frame: 24 months ]
    Objective response rate
  • DoR [ Time Frame: 24 months ]
    Duration of response
  • 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.
  • OS [ Time Frame: 24 months ]
    Overall survival
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2017)
  • Disease control rate [ Time Frame: 24 months ]
  • Objective response rate [ Time Frame: 24 months ]
  • Duration of response [ Time Frame: 24 months ]
  • 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.
  • Overall survival [ Time Frame: 24 months ]
  • 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
  • Quality of life [ Time Frame: 24 months ]
    EQ-5D
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Apatinib in Radioactive Iodine-refractory Differentiated Thyroid Cancer
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Study of Apatinib in Locally Advanced or Metastatic Radioactive Iodine-refractory Differentiated Thyroid Cancer
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 effectively, which is a proven and effective drug in many solid tumors. A phase II study aims to assess the efficacy and safety of apatinib in RAIR-DTC ,which enrolled 20 patients and 10 of them had obtained a shout-term efficacy, demonstrating 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.
Detailed Description

Primary Outcome Measure: Progression free survival of apatinib in 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Differentiated Thyroid Cancer
Intervention  ICMJE
  • Drug: Apatinib Oral Tablet
    Apatinib Mesylate Tablets
  • Drug: Placebo Oral Tablet
    Placebo Oral Tablet
Study Arms  ICMJE
  • Experimental: Apatinib
    Apatinib Mesylate Tablets
    Intervention: Drug: Apatinib Oral Tablet
  • Placebo Comparator: Placebo
    Placebo Tablets
    Intervention: Drug: Placebo Oral Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 7, 2017)
118
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03048877
Other Study ID Numbers  ICMJE PUMCH-NPLA81H-Ahead-T302
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yansong Lin, Peking Union Medical College Hospital
Study Sponsor  ICMJE Peking Union Medical College Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Peking Union Medical College Hospital
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP