Study of Apatinib in Patients With Differentiated Thyroid Cancer

NCT02731352 | Completed Phase 2

• 1 other identifier: Ahead-T301
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Thyroid Cancer

Keywords

apatinib; Iodine-131; Differentiated Thyroid Cancer; refractory; resistant

Outcome Measures

Primary Outcomes (2)

• Disease control rate (DCR)

  Disease control rate

  An expected average of 8 weeks

• Objective response rate (ORR)

  Objective response rate

  An expected average of 8 weeks

Secondary Outcomes (2)

• Progression free survival (PFS)

  Up to approximately 43 months

• Overall survival (OS)

  Up to approximately 48 months

Study Arms (1)

iodine-131 Refractory/Resistant Differentiated Thyroid Cancer

EXPERIMENTAL

iodine-131 (131I) -Refractory/Resistant Differentiated Thyroid Cancer

Drug: Apatinib

Interventions

Apatinib DRUG

Apatinib Mesylate Tablets 750 mg q.d p.o. in 1-10 cases of differentiated thyroid cancer subjects.

Also known as: Apatinib 750mg

iodine-131 Refractory/Resistant Differentiated Thyroid Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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)
• main organs function is normal;
• Eastern Cooperative Oncology Group（ECOG）Performance Status（PS） :0-2;
• An expected survival of ≥ 3 months;
• 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;
• Patient has to voluntarily join the study and sign the Informed Consent Form for the study;

You may not qualify if:

• Other thyroid cancer histological subtypes (such as medullary carcinoma, lymphoma or sarcoma);
• Received VEGFR inhibitor treatment within 1 month;
• 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;
• Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
• 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;
• Abnormal Coagulation (INR\>1.5、APTT\>1.5 UNL), with tendency of bleed;
• Received anti-thyroid cancer chemotherapy treatment (allows the use of low-dose chemotherapy with radiation sensitizer) or thalidomide(or derivative) therapy;
• Pregnant or lactating women;
• Other conditions regimented at investigators' discretion.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Related Publications (3)

• Sun D, Zhang X, Jin X, Shi C, Sun Y, Zhang Y, Liang J, Lin Y. BRAFV600E mutation is associated with better prognoses in radioactive iodine refractory thyroid cancer patients treated with multi-kinase inhibitors: a retrospective analysis of registered clinical trials. Thyroid Res. 2025 Feb 10;18(1):5. doi: 10.1186/s13044-025-00223-0.

  PMID: 39924483 DERIVED

• Lin YS, Zhang X, Wang C, Liu YQ, Guan WM, Liang J. Long-Term Results of a Phase II Trial of Apatinib for Progressive Radioiodine Refractory Differentiated Thyroid Cancer. J Clin Endocrinol Metab. 2021 Jul 13;106(8):e3027-e3036. doi: 10.1210/clinem/dgab196.

  PMID: 33769497 DERIVED

• Zhang X, Wang C, Lin Y. Pilot Dose Comparison of Apatinib in Chinese Patients With Progressive Radioiodine-Refractory Differentiated Thyroid Cancer. J Clin Endocrinol Metab. 2018 Oct 1;103(10):3640-3646. doi: 10.1210/jc.2018-00381.

  PMID: 30053006 DERIVED

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. M.D.

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: April 7, 2016
• Study Start: March 11, 2016
• Primary Completion: February 27, 2020
• Study Completion: February 28, 2021
• Last Updated: January 20, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)