Clinical Trials Directory

Trials / Terminated

TerminatedNCT05405439

To Evaluate the Efficacy of TQB3823 Combined With Abiraterone and Prednisone in Metastatic Castration-resistant Prostate Cancer Patientsprednisone Acetate Tablets in Patients With Metastatic Castration-resistant Prostate Cancer

Phase Ib/II Clinical Study of TQB3823 Tablets Combined With Abiraterone Acetate Tablets and Prednisone Acetate Tablets in Patients With Metastatic Castration-resistant Prostate Cancer

Status
Terminated
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
39 (actual)
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
Sex
Male
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGTQB3823 tabletsTQB3823 tablet is an inhibitor of poly ADP-ribose polymerase (PARP).
DRUGAbiraterone acetate tabletsAbiraterone acetate tablet is an inhibitor of cytochrome P450 17（CYP17）
DRUGprednisone acetate tabletsPrednisone acetate tablet is a kind of glucocorticoids

Timeline

Start date
2022-08-25
Primary completion
2023-07-19
Completion
2023-07-19
First posted
2022-06-06
Last updated
2023-11-03

Locations

23 sites across 1 country: China

Source: ClinicalTrials.gov record NCT05405439. Inclusion in this directory is not an endorsement.