To evaluate the efficacy and safety of SPH7485 tablets in patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
170
SPH7485: Orally, once daily, 50-400mg, 21 days per cycle
XiangYa Hospital CentralSouth University
Changsha, China
RECRUITINGFujian Cancer Hospital
Fuzhou, China
RECRUITINGZhejiang Cancer Hospital
Hangzhou, China
DLT(Dose-limiting toxicity)
Measurement of DLT of SPH7485 in all subjects
Time frame: Approximately 24 days
Maximum tolerated dose(MTD)
Measurement of MTD of SPH7485 in all subjects
Time frame: Approximately 24 days
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Approximately 2 years
ORR(Objective Response Rate)
Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
Time frame: Approximately 2 years
DoR(Duration of response)
DOR was defined as the time interval between the date of the first documented response (CR or PR) and the date of the first documented disease progression or death due to any cause
Time frame: Approximately 2 years
DCR(Disease Control Rate)
DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease
Time frame: Approximately 2 years
PFS(Progression-free survival)
PFS was defined as the time interval between study treatment initiation and the first occurrence of progression disease or death, whichever occurred first.
Time frame: Approximately 2 years
Jian Zhang
CONTACT
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Yunnan Cancer Hospital
Kunming, China
RECRUITINGFudan University Shanghai Cancer Center
Shanghai, China
RECRUITINGUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
RECRUITINGPK(Pharmacokinetics):Tmax
Time to peak plasma concentration (Tmax)
Time frame: Approximately 3 days
PK(Pharmacokinetics):Cmax
Maximum serum concentration(Cmax)
Time frame: Approximately 3 days
PK(Pharmacokinetics):AUC
Area under the plasma concentration versus time curve (AUC)
Time frame: Approximately 3 days