Status:
NOT_YET_RECRUITING
Darxicilib Combined With Abiraterone Acetate Tablets (II) for the Treatment of Advanced Metastatic Castration-resistant Prostate Cancer.
Lead Sponsor:
Qilu Hospital of Shandong University
Collaborating Sponsors:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
The Efficacy of Abiraterone Acetate Combined With Dalpicilib in the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 subjec...
Detailed Description
1. This research constitutes a phase II, single-arm, multicenter exploratory study aimed at assessing the therapeutic efficacy and safety profile of the combination therapy involving Darxicilib and Ab...
Eligibility Criteria
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);
Key Trial Info
Start Date :
July 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT06500247
Start Date
July 31 2024
End Date
March 31 2027
Last Update
July 15 2024
Active Locations (1)
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1
Qilu hospital
Jinan, Shandong, China, 250012