A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3720 Tablets

NCT ID: NCT04853498

Last Updated: 2021-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-19

Study Completion Date

2023-05-30

Brief Summary

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This study is conducted to investigate the pharmacokinetic and safety profiles of TQB3720 in patients with metastatic castration-resistant prostate cancer.

Detailed Description

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Conditions

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Metastatic Castration-resistant Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TQB3720 tablets

TQB3720 tablets administered orally, once daily in 28-day cycle.

Group Type EXPERIMENTAL

TQB3720

Intervention Type DRUG

This is an androgen receptor antagonists.

Interventions

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TQB3720

This is an androgen receptor antagonists.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Dingwei Ye, Doctor

Role: primary

Other Identifiers

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TQB3720-I-01

Identifier Type: -

Identifier Source: org_study_id