Clinical trial · Interventional
Darxicilib Combined With Abiraterone Acetate Tablets (II) for the Treatment of Advanced Metastatic Castration-resistant Prostate Cancer.
A Prospective Exploratory Phase II Study on the Treatment of Advanced Metastatic Castration-resistant Prostate Cancer With Darxicilib in Combination With Abiraterone Acetate (II)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| The Efficacy of Abiraterone Acetate Combined With Dalpicilib in the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abiraterone Acetate (II) | Drug | Abiraterone | ALIAS |
| Androgen Deprivation Therapy | Drug | — | UNRESOLVED |
| Dalpicilib | Drug | — | UNRESOLVED |
| Prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- experimental group
- description
- Androgen Deprivation Therapy+Darxicilib+Abiraterone Acetate(II)+Prednisone
- interventionNames
- Drug: Dalpicilib
- Drug: Abiraterone Acetate (II)
- Drug: Androgen Deprivation Therapy
- Drug: Prednisone
Primary outcomes (1)
- measure
- 12 Week PSA 50
- timeFrame
- 12 weeks
- description
- Response rate of PSA 50 at the end of 12 weeks.
Secondary outcomes (5)
- measure
- Radiographic Progression-Free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years old, male; * ECOG performance status score of 0 to 1; * Life expectancy of at least 3 months; * Histologically or cytologically confirmed adenocarcinoma of the prostate, without a diagnosis of neuroendocrine or small cell carcinoma; * Testosterone at castrate levels at screening (≤50 ng/dL or 1.73 nmol/L); * Failure of previous treatment with new androgen receptor antagonists at the mHSPC stage (such as enzalutamide, apalutamide, ODM-201, SHR3680, HC-1119, and pucrol); * Capable of complying with the study protocol as judged by the investigator; Exclusion Criteria: * Previously received abiraterone acetate treatment for prostate cancer; * Previously received any cytotoxic chemotherapy for mCRPC stage; * Previously received treatment with any other cyclin-dependent kinase 4 and 6 (CDK4 \& 6) inhibitors; * Previously received treatment with new androgen receptor antagonists at the mCRPC stage (such as enzalutamide, apalutamide, ODM-201, SHR3680, HC-1119, and pucrol); * The washout period from the end of any previous anti-tumor treatment (including radiotherapy, surgery, molecular targeted therapy, immunotherapy, and first-generation androgen receptor antagonists) to the first administration of this study is less than 4 weeks (except for bicalutamide with a washout period less than 6 weeks);
References
Publications (0)
Data not yet available