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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
HA121-28 450 mg, po, QD×21 days, every 4 weeks (28 days)
Beijing Tongren Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGCancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Objective remission rate (ORR)
assessed approximately every 8 weeks or 12 weeks based on the treatment cycle
Time frame: From date of randomization until the date of first documented progression or date of death from any cause,whichever came first, assessed up to 60 months
Progression-free survival (PFS)
assessed approximately every 8 weeks or 12 weeks based on the treatment cycle
Time frame: From date of randomization until the date of first documented progression, assessed up to 60 months
Duration of response (DOR)
assessed approximately every 8 weeks or 12 weeks based on the treatment cycle
Time frame: From date of randomization until the date of first documented progression or date of death from any cause,whichever came first, assessed up to 60 months
Overall survival (OS)
assessed approximately every 12 weeks
Time frame: From date of randomization until date of death from any cause, assessed up to 60 months
Disease control rate (DCR)
assessed approximately every 8 weeks or 12 weeks based on the treatment cycle
Time frame: From date of randomization until the date of first documented progression or date of death from any cause,whichever came first, assessed up to 60 months
Changes in blood calcitonin
assessed approximately every 8 weeks
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, or date of death from any cause,whichever came first, assessed up to 60 months
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Fujian Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGGansu Province Tumor Hospital
Lanzhou, Gansu, China
NOT_YET_RECRUITINGSun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGHenan Province Tumor Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGJiangsu province tumor hospital
Nanjing, Jiangsu, China
NOT_YET_RECRUITINGCancer Hospital of Fudan University
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGSichuan Cancer Hospital
Chengdu, Sichuan, China
NOT_YET_RECRUITINGTianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
NOT_YET_RECRUITING...and 3 more locations
Adverse events incidence
assessed approximately every 4 weeks
Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months
Plasma drug concentration
assessed approximately every 4 weeks
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, wihichever came first, assessed up to 60 months