Back to resultsA Study to Evaluate the Tolerance and Pharmacokinetics of TQB3720 Tablets
Primary Purpose
Metastatic Castration-resistant Prostate Cancer
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TQB3720
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Castration-resistant Prostate Cancer
Eligibility Criteria
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.
Sites / Locations
- Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TQB3720 tablets
Arm Description
TQB3720 tablets administered orally, once daily in 28-day cycle.
Outcomes
Primary Outcome Measures
Maximum tolerated dose (MTD)
MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.
Secondary Outcome Measures
Cmax
Cmax is the maximum plasma concentration of TQB3720 or metabolite(s).
Tmax
To characterize the pharmacokinetics of TQB3720 by assessment of time to reach maximum plasma concentration.
AUC0-t
To characterize the pharmacokinetics of TQB3720 by assessment of area under the plasma concentration time curve from zero to infinity.
Full Information
NCT ID
NCT04853498
First Posted
April 20, 2021
Last Updated
November 23, 2021
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04853498
Brief Title
A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3720 Tablets
Official Title
A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance and Pharmacokinetics of TQB3720 Tablets
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 19, 2021 (Actual)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is conducted to investigate the pharmacokinetic and safety profiles of TQB3720 in patients with metastatic castration-resistant prostate cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Castration-resistant Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TQB3720 tablets
Arm Type
Experimental
Arm Description
TQB3720 tablets administered orally, once daily in 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
TQB3720
Intervention Description
This is an androgen receptor antagonists.
Primary Outcome Measure Information:
Title
Maximum tolerated dose (MTD)
Description
MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.
Time Frame
Baseline up to 28 days
Secondary Outcome Measure Information:
Title
Cmax
Description
Cmax is the maximum plasma concentration of TQB3720 or metabolite(s).
Time Frame
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.
Title
Tmax
Description
To characterize the pharmacokinetics of TQB3720 by assessment of time to reach maximum plasma concentration.
Time Frame
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.
Title
AUC0-t
Description
To characterize the pharmacokinetics of TQB3720 by assessment of area under the plasma concentration time curve from zero to infinity.
Time Frame
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.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200035
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dingwei Ye, Doctor
Phone
34778299
Email
17858618786@163.com
First Name & Middle Initial & Last Name & Degree
Dingwei Ye, Doctor
12. IPD Sharing Statement
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A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3720 Tablets
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