drugset / Trial / NCT06500247
Darxicilib Combined With Abiraterone Acetate Tablets (II) for the Treatment of Advanced Metastatic Castration-resistant Prostate Cancer.
Phase 2
Not yet recruiting
43 enrolled
Qilu Hospital of Shandong University
Jiangsu HengRui Medicine Co., Ltd. · collab
NaSingle-groupOpen-labelTreatment
Summary
This study is a single-arm, multicenter, phase II exploratory trial. The purpose is to explore the efficacy and safety of Darxicilib in combination with Abiraterone Acetate for the treatment of subjects with metastatic castration-resistant prostate cancer.The main questions it aims to answer are: ·PSA50 response rate at the end of week 12 Participants will: * Darxicilib: 125mg per tablet, oral administration, once daily for 21 consecutive days followed by a 7-day break. * Abiraterone Acetate tablets (II): 300mg per dose, oral administration, once daily for a 28-day cycle. * Prednisone: 5mg per tablet, oral administration, twice daily.
Timeline
- Start
- 2024-07-31
- Primary completion
- 2027-03-31
- Completion
- 2027-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abiraterone acetate | Small molecule | 300 mg | Oral |
| Subject | Dalpicilib | Unknown | 125 mg | Oral |
| Background | Prednisone | Other / unclassified | 5 mg | Oral |
Indications
No indication recorded.