A Clinical Study of Apatinib in Patients With Local Progressive/Metastatic Refractory Thyroid Cancer
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|ClinicalTrials.gov Identifier: NCT03199677|
Recruitment Status : Unknown
Verified June 2017 by Shengyu Zhou, Chinese Academy of Medical Sciences.
Recruitment status was: Recruiting
First Posted : June 27, 2017
Last Update Posted : July 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Refractory Cancer||Drug: Apatinib||Phase 2|
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.
The primary endpoint is objective response rate(ORR),the secondary endpoints include progression-free-survival(PFS)；disease control rate(DCR);serum Tg、TgAb、calcitonin；safety.
If any case happens as following,including withdrawing informed consent form(ICF)、unbearable toxicity or adverse reactions、other conditions which investigators think the patients are unsuitable to go on trail,the patient will not go on trial any longer,or every subject will obtain study treatment until tumor progress with CT/MRI proof.The indicators of efficacy and safety will be always observed during the trail process.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||single group,apatinib 500mg po qd,d1-28|
|Masking:||None (Open Label)|
|Masking Description:||no parallel,no control|
|Official Title:||An Exploratory Single-center, Open-label , Clinical Study of Apatinib in Patients With Local Progressive/Metastatic Refractory Thyroid Cancer|
|Estimated Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||June 30, 2018|
|Estimated Study Completion Date :||June 30, 2018|
Experimental: apatinib with 500mg qd po
Patients administrate apatinib with the dose of 500mg once per day,half an hour after a meal.
Apatinib is an oral tyrosine kinase inhibitor.
- objective response rate [ Time Frame: 1 year ]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).
- progression-free-survival(PFS) [ Time Frame: 1 year ]From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
- disease control rate(DCR) [ Time Frame: 1 year ]Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1（RECIST1.1）.
- serum Tg、TgAb、calcitonin [ Time Frame: 1 year ]Evaluating the change of serum level of Tg，TgAb or calcitonin,assessed up to 12 months.
- Adverse Events(AEs) [ Time Frame: 1 year ]Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199677
|Contact: Shengyu Zhou, email@example.com|
|Contact: Hongzhe Wang, firstname.lastname@example.org|
|Cancer Hospital, Chinese Academy of Medical Sciences||Recruiting|
|Beijing, Beijing, China, 100021|
|Contact: Dawei Wu, professor 13521689314 email@example.com|
|Principal Investigator: Shengyu Zhou, professor|