Spots Global Cancer Trial Database for A Study of HA121-28 Tablets in Patients With Medullary Thyroid Carcinoma (MTC)
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Trial Identification
Brief Title: A Study of HA121-28 Tablets in Patients With Medullary Thyroid Carcinoma (MTC)
Official Title: A Single-arm, Open-Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of HA121-28 Tablets in Patients With Medullary Thyroid Carcinoma (MTC)
Study ID: NCT04787328
Conditions
Interventions
Study Description
Brief Summary: This is a single-arm, open-label, multicenter study designed to evaluate the preliminary antineoplastic activity, safety and tolerability of HA121-28 tablets administered orally in patients with medullary thyroid cancer (MTC).
Detailed Description: A total of approximately 30 patients with MTC will be enrolled. The patients will undergo a 3 weeks-on and 1week-off treatment scheme with HA121-28 tablets 450 mg orally once daily in the 28-day cycle until disease progression or intolerable toxic reaction, whichever occurs first. During the administration of HA121-28 tablets, vital signs, physical examination, ECOG performance status, hematology and chemistry test, ECG, adverse events and concomitant drugs will be evaluated every four weeks, an additional ECG will be observed two weeks after the first dose, calcitonin and pregnancy test will be performed every 8 weeks. CT for tumor assessment will be performed every 8 weeks for the first year, and every 12 weeks thereafter.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Beijing Tongren Hospital, Beijing, Beijing, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, China
Fujian Cancer Hospital, Fuzhou, Fujian, China
Gansu Province Tumor Hospital, Lanzhou, Gansu, China
Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, China
Henan Province Tumor Hospital, Zhengzhou, Henan, China
Jiangsu province tumor hospital, Nanjing, Jiangsu, China
Cancer Hospital of Fudan University, Shanghai, Shanghai, China
Sichuan Cancer Hospital, Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, China
Tianjin People's Hospital, Tianjin, Tianjin, China
The First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China
Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China
Contact Details
Name: Wen Xu, Master
Affiliation: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Role: STUDY_DIRECTOR
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