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NOT YET RECRUITING
NCT06099990
PHASE1

Dalpiciclib Isethionate Tablets Combined With Abiraterone Acetate Tablets (I) and Prednisone Tablets (AA-P) Versus Placebo Combined With AA-P in Treatment of High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)

Sponsor: Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

Summary

This study was to evaluate the safety and efficacy of dalcilide tablets in combination with AA-P in the treatment of subjects with high tumor burden mHSPC and to determine the second stage starting dose and progression-free survival(rPFS) based on BICR assessment

Official title: A Multicenter, Randomized, Double-blind Phase Ib/III Clinical Study of Dalpiciclib Isethionate Tablets Combined With Abiraterone Acetate Tablets (I) and Prednisone Tablets (AA-P) Versus Placebo Combined With AA-P in Treatment of High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC).

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

660

Start Date

2023-10

Completion Date

2028-12

Last Updated

2023-10-25

Healthy Volunteers

No

Interventions

DRUG

dalpiciclib isethionate tablets; abiraterone acetate tablets; prednisone tablets

dalpiciclib+ abiraterone+ prednisone

DRUG

placebo; abiraterone acetate tablets; prednisone tablets

placebo+abirarerone+prenisone