This is an open-label,single arm,Phase Ib study,in order to evaluate the safety,tolerability, preliminary efficacy and pharmacokinetics of TQ05105 tablets in subjects with Glucocorticoid-Refractory aGVHD
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Participants began oral administration of TQ05105 tablets at 10 mg twice daily (BID),followed by 5 mg or 15 mg BID depending on the situation of the study. twice daily in 28-day cycle until disease progression/intolerance occurs or the sponsor terminates the study.
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Hematology Hospital of the chinese Academy of Medical Sciences
Tianjing, Tianjing, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Drug tolerance of the first cycle (Stage 1)
Dose-limiting toxicity events related to the investigational drug occured within 28 days after initial administration
Time frame: Day 28 after initial administration
Objective Response Rate (ORR) at Day 28 (Stage 2)
Percentage of subjects with complete response (CR) or very good partial response (VGPR) or partial response (PR) at Day 28
Time frame: Day 28 after initial administration
CR Rate at Day 28
Percentage of subjects with CR at Day 28
Time frame: Day 28 after initial administration
ORR at Day 28 and Day 56
Percentage of subjects with CR or VGPR or PR at Day 28 and Day 56
Time frame: Day 28 and Day 56 after initial administration
Duration of Response (DOR)
From date of first recorded remission to date of first recorded disease progression or date of starting any new systemic therapy for aGVHD
Time frame: From initial administration to day 30 after the last administration
Cumulative dose of glucocorticoid at Day 56
Totally and weekly cumulative dose of glucocorticoid of each subject,from initial administration to Day 56 or the day end of therapy
Time frame: Day 56 after initial administration
Event Free Survival (EFS)
From the date of initial administration to the date of recurrence/progression of hematological diseases or transplant failure or death from any cause
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Time frame: From initial administration to Day 30 day after the last administration
Overall Survival (OS)
Time from randomization to death
Time frame: From initial administration to day 30 days after the last administration
Incidence of Malignancy Relapse/Progression(MR),Non-Relapse Mortality(NRM)
From the date of first administration to the date of death due to recurrence/progression of non hematological diseases; the date of recurrence or progression of hematological diseases
Time frame: From initial administration to 30 days after the last administration
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Incidence of AEs and SAEs
Time frame: From initial administration to day 30 after the last administration
Tmax
The pharmacokinetic parameters were measured after single and multiple administration: peak time(Tmax)
Time frame: 7 days after initial administration
Cmax
The pharmacokinetic parameters were measured after single and multiple administration: peak concentration(Cmax)
Time frame: 7 days after initial administration
AUC0-t
The pharmacokinetic parameters were measured after single and multiple administration: area under the blood concentration-time curve (AUC0-t)
Time frame: 7 days after initial administration