dalpiciclib isethionate tablets; abiraterone acetate tablets; prednisone tablets
Drugdalpiciclib+ abiraterone+ prednisone
NCT Number: NCT06099990
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
Trial opening soon.
Get Notified18 year and older
Male
Interventional
Phase 1
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
dalpiciclib+ abiraterone+ prednisone
placebo+abirarerone+prenisone
Time frame: approximately 63 months
Time frame: approximately 6 months
Time frame: approximately 63 months
Time from randomisation to radiologically confirmed progressive disease or death due to any cause
Time frame: approximately 63 months
In patients who had not started androgen deprivation prior to randomization, the proportion of patients whose PSA levels were ≥ 90% lower than baseline by the end of the study treatment week
Time frame: approximately 63 months
Objective response rate+ The proportion of participants evaluated according to RECIST v1.1 and PCWG3 criteria that achieved predetermined tumor volume reduction and maintained the minimum duration was the sum of the proportion of complete and partial responses
Time frame: approximately 63 months
Time from randomisation to the first time of PSA progression
Contact information is provided by the study sponsor or research team.
Jiangsu HengRui Medicine Co., Ltd.
Industry
A Multicenter, Randomized, Double-blind Phase Ib/III Clinical Study of 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).
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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