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

NCT03167385 | Unknown Phase 2

• 1 other identifier: AHEAD-HBT001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Differentiated Thyroid Carcinoma

Keywords

locally advanced differentiated thyroid carcinoma; radioiodine refractory thyroid carcinoma

Outcome Measures

Primary Outcomes (1)

• disease control rate

  percentage of patients who have achieved complete response, partial response and stable disease to overall therapeutic intervention patients

  within two weeks of drug administration

Secondary Outcomes (3)

• progression free survival

  2 years

• overall survival

  2 years

• objective response rate

  2 weeks

Study Arms (1)

Experitmental

EXPERIMENTAL

Continuous oral intake of Apatinib Mesylate (500mg), once a day, until progression of disease or severe adverse effect.

Drug: Apatinib Mesylate

Interventions

Apatinib Mesylate DRUG

oral intake of Apatinib Mesylate 500mg once a day until progression of diesase or severe adverse effect

Also known as: YN968D1

Experitmental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent.
• Histopathology confirmed locally advanced or metastatic differentiated thyroid carcinoma, with measurable lesions (RECIST 1.1).
• Age:18-75 years, ECOG（Eastern Cooperative Oncology Group） Score:0-2, Expected survival period ≥ 3 months.
• Patients with disease progression which was confirmed by imaging in 18 months, and meet any one of the following four:
• The tumor invades important organs, and cannot be resectted completely, the remnant thyroid tissue is extensive and not suitable for further iodine treatment.
• Lesions have no iodine affinity.
• The cumulative dose of RAI (radioactive iodine) ≥ 600mCi or 22GBq.
• Patients with disease progression confirmed by radiological examination within 18 months of last RAI.
• 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.
• Past history of less than one kind of tyrosine kinase inhibitor.
• 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.

You may not qualify if:

• Patients with past apatinib treatment or have received two or more small molecular TKI (Tyrosine Kinase Inhibitor) drugs.
• 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.
• 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.
• Patients without unrelieved toxicity reaction above CTCAE grade, neurotoxicity and hair loss due to oxaliplatin are spared.
• Preconditions that impair successful oral medication intake (such as inability to swallow, chronic diarrhea).
• Patients with pleural effusion or ascites that lead to respiratory syndrome (above CTCAE grade 2).
• Patients with severe systemic diseases that might impair cardiac function, et al.
• Patients accepted major surgery、incision biopsy or obvious traumatic injury in 28 days before the study.
• Patients with physical signs or medical history of bleeding.
• Patients with thromboembolism event in 6 months.
• Patients with history of aneurysm.
• Patients with epilepsy which needs medication.
• Patients with history of psychiatric drug abuse or have a mental disorder.
• Patients with history of disease in peripheral nervous system, muscle strength under level 3.
• Attended other antitumor drug clinical trials or other ongoing clinical subjects within 4 weeks.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Interventions

apatinib

Study Officials

• Ming Gao, MD

  Tianjin Medical University Cancer Institute and Hospital

  STUDY CHAIR

Central Study Contacts

Ming Gao, MD

CONTACT

862223340123; gaoming@tjmuch.com

Xiangqian Zheng, MD

CONTACT

862223340123; xiangqian_zheng@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 30, 2017
• Study Start: March 22, 2017
• Primary Completion: January 31, 2019
• Study Completion: December 31, 2020
• Last Updated: May 30, 2017

Record last verified: 2017-03

Locations

CN (1)