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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.
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
dalpiciclib isethionate tablets; abiraterone acetate tablets; prednisone tablets
dalpiciclib+ abiraterone+ prednisone
placebo; abiraterone acetate tablets; prednisone tablets
placebo+abirarerone+prenisone