drugset / 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)
RandomizedParallel-groupQuadruple-blindTreatment
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
Timeline
- Start
- 2023-10
- Primary completion
- 2028-12
- Completion
- 2028-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dalpiciclib | Small molecule | — | — |
| Background | Abiraterone acetate | Small molecule | — | — |
| Background | Prednisone | Other / unclassified | — | — |