A Clinical Study of Apatinib in Patients With Local Progressive/Metastatic Refractory Thyroid Cancer

NCT03199677 | Unknown Phase 2

• 1 other identifier: AHEAD-RTC001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, open-label, single arm，exploratory clinical trial evaluating the efficacy and safety of Apatinib in patients with local progressive/metastatic refractory thyroid cancer.

Conditions

Refractory Cancer

Keywords

apatinib,refractory thyroid cancer

Outcome Measures

Primary Outcomes (1)

• objective response rate

  ORR is defined as the percentage of subjects having achieved confirmed Complete Response+Partial Response as best overall response according to Response Evaluation Criteria Solid Tumors(RECIST 1.1).

  1 year

Secondary Outcomes (4)

• progression-free-survival(PFS)

  1 year

• disease control rate(DCR)

  1 year

• serum Tg、TgAb、calcitonin

  1 year

• Adverse Events(AEs)

  1 year

Study Arms (1)

apatinib with 500mg qd po

EXPERIMENTAL

Patients administrate apatinib with the dose of 500mg once per day,half an hour after a meal.

Drug: Apatinib

Interventions

Apatinib DRUG

Apatinib is an oral tyrosine kinase inhibitor.

apatinib with 500mg qd po

Eligibility Criteria

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

You may qualify if:

• ≥18 years old，gender limitation.
• The pathologic subtype of thyroid carcinoma, which was confirmed by histopathological histology, included iodine refractory thyroid papillary carcinoma and follicular carcinoma, medullary thyroid carcinoma and undifferentiated carcinoma.
• Patients with at least one measurable lesion (RECIST1.1), at least one measurable lesion after the treatment (spiral CT scan length to diameter 10 mm or higher, according with the requirement of RESCIST version 1.1 standard).
• Radioactive iodine deficiency (according with one of the following conditions):
• The target lesion was completely deprived of iodine in the treatment of radioactive iodine;
• The patients were treated with single dose of iodine (3.7 GBq) and the disease progressed in 12 months;
• The patients were given an iodine treatment interval of less than 12 months, and the dose was greater than that 3.7 GBq \[≥100mCi\], with at least one iodine treatment over 12 months of disease progression;
• Cumulative doses of radioactive iodine were greater than 22.2 GBq (or more than 600 mCi).
• Patients who underwent at least one failure of standard chemotherapy can be recommended to get into the group.
• Organs function have to be compliant with the following specifications:
• ANC≥1.5×109/L; PLT≥100×109/L; Hb≥90g/L; TBIL≤1.5×ULN; ALT \&AST ≤2.5×ULN ; ALT \&AST ≤5×ULN in patients with hepatic metastasis; BUN \& Cr≤1×ULN, CCR≥50mL/min (Cockcroft-Gault formula); Normal coagulation function (INR\<1.5 or PT\<ULN+4s or APTT\<1.5 ULN); Urinary protein\<++ or urine protein quantitation in 24 hours ≤1.0 g.
• Life expectancy ≥ 12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0\~2.
• Pre-menopausal women must have a negative pregnancy test within 7 days before study entry and agree to use a medically acceptable method of contraception throughout the treatment periods and for at least six weeks after treatment discontinuation.
• The subjects volunteered to participate in the study, sign informed consent forms, and compliance with follow-up.

You may not qualify if:

• The presence of a third interstitial fluid (such as a large amount of pleural effusion and/or peritoneal fluid, pericardial fluid) that cannot be controlled by a drainage or other methods.
• Before or at the same time with other malignant tumors, except cured skin basal cell carcinoma, cervical carcinoma in situ or other effective treatment of tumors and did not see signs of disease for five years.
• The patients who used VEGFR-TKI drugs, such as Vandetanib， Cabozantinib， Lenvatinib，Sunitinib，Sorafenib in one month.
• Inability to swallow, chronic diarrhea and obstruction of the intestine, various factors which affect drug use and absorption.
• major surgical or severe trauma injuries, fractures, or ulcers before 4 weeks of enrolling , 3 weeks of radiation therapy (except for partial palliative radiation), chemotherapy, and molecular target therapy in three weeks, Treatment with nitrocarbamide or mitomycin before six weeks of enrolling.
• uncontrolled hypertension (systolic blood pressure of 140mmHg or diastolic pressure is greater than 90mmHg, despite the best drug treatment).
• Patients used to suffer from severe cardiovascular diseases: Ⅱ magnitude of myocardial ischemia and myocardial infarction, poor control of cardiac arrhythmias (including QTc interphase male ≥450ms, female≥470ms); According to NYHA standard, Ⅲ \~ Ⅳ cardiac insufficiency, or heart color indicate left ventricular ejection fraction (LVEF) \< 50%.
• History of significant hemoptysis within 2 months prior to enrollment or daily hemoptysis is up to 2.5ml;with the trend of haemorrhage or prior treatment with an angiogenesis therapy.
• Significant clinical significance of bleeding symptoms or a definite bleeding tendency happened in three months prior to screening, such as gastrointestinal bleeding, bleeding ulcers, baseline period + + and above of defecate occult blood, or those with vasculitis, etc.
• Active brain metastasis, cancer meningitis, Spinal cord oppressor activity of brain metastases of, cancer, spinal cord compression patients, CT or MRI examination revealed brain or soft meningeal disease (patients who completed treatment and get stable symptoms with brain metastases can be into the group in 21 days prior to screening, without symptoms of cerebral hemorrhage).
• Imaging (CT or MRI) showed that tumor lesions were less than 5mm from the large blood vessels, or the central type of tumor that had penetrated the large blood vessels, or there is a clear pulmonary void or necrotic tumor.
• Patients accept other anti-tumor therapies at the same time.
• Treatment of thyroid cancer radiation was received 28 days prior to screening.
• Participated in other clinical trials within 4 weeks.
• Active or chronic hepatitis c and/or hepatitis b infection and other active infections (determined by the investigators).

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Neoplasms; Thyroid Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Shengyu Zhou, professor

CONTACT

13520852899; typhoonwho@126.com

Hongzhe Wang, doctor

CONTACT

18911052235; aiesecarrow@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: no parallel,no control
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of the physician

Model Details: single group,apatinib 500mg po qd,d1-28

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: June 27, 2017
• Study Start: July 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: July 2, 2017

Record last verified: 2017-06

Locations

CN (1)