This is a phase Ib/II clinical study to explore the safety and efficacy of TQB3823 tablets combined with abiraterone acetate tablets and prednisone acetate tablets in patients with metastatic castration-resistant prostate cancer.
This is a two-phase, open-label Phase Ib clinical trial. The first phase plans to enroll 6-12 patients as two cohorts to explore the safety and of TQB3823 tablets combined with abiraterone and prednisone and the recommended dose of phase II of TQB3823. Subjects involved in cohort one accepts TQB3823 treatment during cycle one and then TQB3823 combined with abiraterone and prednisone from cycle two till the disease progression. The second phase plans to enroll a total of 40-60 subjects, aiming to evaluate the safety and efficacy of TQB3823 tablets combined with abiraterone and prednisone.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
TQB3823 tablet is an inhibitor of poly ADP-ribose polymerase (PARP).
Abiraterone acetate tablet is an inhibitor of cytochrome P450 17(CYP17)
Prednisone acetate tablet is a kind of glucocorticoids
The First Hospital of Peking University
Dose limiting toxicity (DLT)
The relevant adverse reactions occurred within the first cycle
Time frame: Up to 4 weeks
Recommended phase II dose (RP2D)
The dose of TQB3823 tablet which is recommended to use during phase II clinical trial
Time frame: Up to 8 weeks
The ratio of subject radiographic progression-free survival for 12 months
Proportion of subjects without disease progression assessed by radiology within 12 months
Time frame: For 12 months
Adiographic progression-free survival (rPFS)
rPFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause evaluated by radiological examination
Time frame: Up to 24 months
The ratio of subject radiographic progression-free survival for 12 months
Proportion of subjects without disease progression assessed by radiology within 6 months
Time frame: For 6 months
The ratio of prostate specific antigen (PSA) reduction
Proportion of subjects with reduction of PSA
Time frame: Up to 24 months
Overall response rate (ORR) based on 2014 Lugano
Percentage of participants achieving complete response (CR) and partial response (PR).
Time frame: Up to 24 months
Overall survival (OS)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Beijing, Beijing Municipality, China
The Southwest Hospitai of Amu
Chongqing, Chongqing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
The Second Hospital of Harbin Medical University
Lanzhou, Gansu, China
Sun Yat-Sun University Cancer Prevertion and Treatment Center
Guangzhou, Guangdong, China
Qingyuan People's Hospital
Qingyuan, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
...and 13 more locations
OS defined as the time from randomization until the death from any cause
Time frame: Up to death
Clinical benefit rate (CBR)
Proportion of subjects with clinical benefit
Time frame: Up to 24 months
Duration of Response (DOR)
The time when the participants first achieved CR or PR to disease progression or death from any cause.
Time frame: Up to 24 months
time to bone-related event
Time to progression of bone disease in subjects
Time frame: Up to 24 months
Time to PSA progression
Time to raise of PSA in subjects
Time frame: Up to 24 months
Peak time (Tmax)
The time to peak concentration
Time frame: Cycle 1 day 1 and cycle 1 day 28 Before administration, and 1, 2, 4, 6, 8, 11, 12, 24 hours after administration. Cycle 1 day 14 before administration,(each cycle is 28 days)
Peak concentration (Cmax)
Maximum plasma drug concentration
Time frame: Cycle 1 day 1 and cycle 1 day 28 Before administration, and 1, 2, 4, 6, 8, 11, 12, 24 hours after administration. Cycle 1 day 14 before administration,(each cycle is 28 days)
Half-life /T1/2
The time it takes for the drug's concentration in the body to drop by half
Time frame: Cycle 1 day 1 and cycle 1 day 28 Before administration, and 1, 2, 4, 6, 8, 11, 12, 24 hours after administration. Cycle 1 day 14 before administration,(each cycle is 28 days)
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Time frame: Baseline up to 96 weeks
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Time frame: Baseline up to 24 months