Study of Apatinib in Patients With Differentiated Thyroid Cancer

January 18, 2022 updated by: Yansong Lin, Peking Union Medical College Hospital

Study of Apatinib in Patients With Local Advanced/Metastatic Iodine-131（131I）-Refractory/Resistant Differentiated Thyroid Cancer

The purpose of this study is to assess the efficacy and safety of apatinib in locally advanced/metastatic radioactive iodine-refractory/resistant differentiated thyroid cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Peking, China, 100730
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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);
  2. Disease progression within 14 months before inclusion;

  3. 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 Becquerel (GBq) [≥ 100 millicurie (mCi) ]) and target lesion disease progression
    • Every two radioactive iodine treatment interval <12 months, doses ≥ 3.7 GBq [≥100 mCi], 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)
  4. main organs function is normal;
  5. Eastern Cooperative Oncology Group（ECOG）Performance Status（PS） :0-2;
  6. An expected survival of ≥ 3 months;
  7. Pregnancy test (serum or urine) 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;
  8. Patient has to voluntarily join the study and sign the Informed Consent Form for the study;

Exclusion Criteria:

  1. Other thyroid cancer histological subtypes (such as medullary carcinoma, lymphoma or sarcoma);
  2. Received VEGFR inhibitor treatment within 1 month;
  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 ClassII; 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, 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. Received anti-thyroid cancer chemotherapy treatment (allows the use of low-dose chemotherapy with radiation sensitizer) or thalidomide(or derivative) therapy;
  8. Pregnant or lactating women;
  9. Other conditions regimented at investigators' discretion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: iodine-131 Refractory/Resistant Differentiated Thyroid Cancer
iodine-131 (131I) -Refractory/Resistant Differentiated Thyroid Cancer
Drug: Apatinib
Apatinib Mesylate Tablets 750 mg q.d p.o. in 1-10 cases of differentiated thyroid cancer subjects.
Other Names:
  • Apatinib 750mg
Drug: Apatinib
Apatinib Mesylate Tablets 500 mg q.d. p.o. in 11-20 cases of differentiated thyroid cancer subjects.
Other Names:
  • Apatinib 500mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control rate (DCR)
Time Frame: An expected average of 8 weeks
Disease control rate
An expected average of 8 weeks
Objective response rate (ORR)
Time Frame: An expected average of 8 weeks
Objective response rate
An expected average of 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: Up to approximately 43 months
progression free survival
Up to approximately 43 months
Overall survival (OS)
Time Frame: Up to approximately 48 months
overall survival
Up to approximately 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2016

Primary Completion (Actual)

February 27, 2020

Study Completion (Actual)

February 28, 2021

Study Registration Dates

First Submitted

March 7, 2016

First Submitted That Met QC Criteria

April 6, 2016

First Posted (Estimate)

April 7, 2016

Study Record Updates

Last Update Posted (Actual)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 18, 2022

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ahead-T301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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