Metastatic Castration-resistant Prostate Cancer
Conditions
Brief summary
This study is conducted to investigate the pharmacokinetic and safety profiles of TQB3720 in patients with metastatic castration-resistant prostate cancer.
Interventions
DRUGTQB3720
This is an androgen receptor antagonists.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Histologically or cytologically confirmed prostate carcinoma. 2.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; Life expectancy ≥12 weeks. 3.Testosterone levels \< 50 ng/dL. 4. Has received ≥1 previous regimens for metastatic castration-resistant prostate cancer. 5.Male subjects should agree to use an adequate method of contraception starting with signing ICF through 6 months after the last dose of study. 6.Understood and signed an informed consent form.
Exclusion criteria
-1.Has symptomatic brain metastases or control of symptoms \< 1 month. 2.Has other malignancies within 3 years. 3.Has used second-generation androgen receptor antagonists. 4. Abnormal liver function. 5. Abnormal renal function. 6. Has received any other investigational drug within 30 days weeks before first dose. 7\. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerated dose (MTD) | Baseline up to 28 days | MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 0hour, 2hour, 4hour, 8hour, 12hour, 24hour, 36hour, 48hour, 72hour, 96hour,120hour post-dose on single dose; Hour 0 of day 8、day 15、day 22；0 hour, 2 hour, 4 hour, 8 hour, 12 hour, 24 hour post-dose on multiple dose of day 28; Hour 0 of day 42 and day 56. | Cmax is the maximum plasma concentration of TQB3720 or metabolite(s). |
| Tmax | 0hour, 2hour, 4hour, 8hour, 12hour, 24hour, 36hour, 48hour, 72hour, 96hour,120hour post-dose on single dose; Hour 0 of day 8、day 15、day 22；0 hour, 2 hour, 4 hour, 8 hour, 12 hour, 24 hour post-dose on multiple dose of day 28; Hour 0 of day 42 and day 56. | To characterize the pharmacokinetics of TQB3720 by assessment of time to reach maximum plasma concentration. |
| AUC0-t | 0hour, 2hour, 4hour, 8hour, 12hour, 24hour, 36hour, 48hour, 72hour, 96hour,120hour post-dose on single dose; Hour 0 of day 8、day 15、day 22；0 hour, 2 hour, 4 hour, 8 hour, 12 hour, 24 hour post-dose on multiple dose of day 28; Hour 0 of day 42 and day 56. | To characterize the pharmacokinetics of TQB3720 by assessment of area under the plasma concentration time curve from zero to infinity. |
Countries
China
Outcome results
None listed