clinical trial · NCT06099990
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)
Jiangsu HengRui Medicine Co., Ltd.·phase1·not yet recruiting·n = 660
High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)dalpiciclib isethionate tablets; abiraterone acetate tablets; prednisone tabletsplacebo; abiraterone acetate tablets; prednisone tablets
brief 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
started
Oct 1, 2023
primary completion
Dec 1, 2028
completion
Dec 1, 2028
last updated
Oct 25, 2023
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).
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol