Tests darxicilib with abiraterone in advanced prostate cancer that stopped responding to hormone therapy
Tests darxicilib plus abiraterone in adults with advanced, spreading prostate cancer.
Plain-language title generated from the registry record
Registry title: Darxicilib Combined With Abiraterone Acetate Tablets (II) for the Treatment of Advanced Metastatic Castration-resistant Prostate Cancer.
Key facts
- Where
- Jinan, ChinaSee the site
- Phase
- Phase 2
Where in China
- Qilu HospitalJinan, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Qilu Hospital of Shandong University
- Trial code
- NCT06500247
- Record updated
- 15 July 2024
- Original description
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:Read full original descriptionShow less
A Prospective Exploratory Phase II Study on the Treatment of Advanced Metastatic Castration-resistant Prostate Cancer With Darxicilib in Combination With Abiraterone Acetate (II)
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.
Inclusion: 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: 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).