This is a study to evaluate the efficacy and safety of TQ-B3525 in subjects with recurrent / metastatic advanced endometrial cancer, cervical cancer and ovarian cancer with PIK3CA and / or PIK3R1 / 2 gene-altered (mutation or amplification). Endometrial cancer, cervical cancer and ovarian cancer are divided into three cohorts, each cohort administrated TQ-B3525 tablet orally once a day.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
TQ-B3525 tablet administered orally once a day. Each cycle is 28 days.
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
NOT_YET_RECRUITINGNanjing Drum Tower Hospital
Nanjing, Jiangsu, China
NOT_YET_RECRUITINGFudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Overall response rate (ORR) assessed by Independent Review Committee
Percentage of participants achieving complete response (CR) and partial response (PR) based on IRC.
Time frame: up to 48 weeks
Overall response rate (ORR) assessed by Investigator
Percentage of participants achieving complete response (CR) and partial response (PR) assessed by investigator.
Time frame: up to 48 weeks
Disease control rate(DCR)
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time frame: up to 48 weeks
Duration of disease remission (DOR)
The time from the first evaluation of the subject as CR or PR to the first evaluation of the subject as PD or death (whichever occurs first).
Time frame: up to 48 weeks
Progression-free survival (PFS)
PFS was defined as the time from the date of study enrollment to the date of the first of the following events, objective disease progression or death due to any cause.
Time frame: up to 48 weeks
Overall survival (OS)
OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.
Time frame: up to 72 weeks
DOR rate (≥ 6 months) (percentage of subjects with disease remission duration ≥ 6 months)
The percentage of subjects achieving CR or PR was recorded for the first time to 6 months after the first time of objective tumor progression or death due to any cause (whichever occurred first) was recorded.
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Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGSir Run Run Shaw Hospital Medical School Zhejiang University
Hangzhou, Zhejiang, China
NOT_YET_RECRUITINGTime frame: up to 48 weeks