CYCLONE 3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination With Abiraterone Plus Prednisone in Men With High-Risk Metastatic Hormone-Sensitive Prostate Cancer - I3Y-MC-JPEG

Masaki Takeshi0 个研究点目标入组 900 人开始时间: 2022年5月31日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Adenocarcinoma of the prostate.
•-High-risk metastatic disease defined as:
•-Greater than or equal to (>=)4 bone metastases and/or
•->=1 visceral metastases
•-Androgen deprivation therapy (either medical with a luteinizing hormone-releasing hormone [LHRH] analogue or surgical castration) must have been started prior to randomization and continued throughout the study.
•-Adequate organ function
•-Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

•-Prior treatment with abemaciclib or any other cyclin dependent kinase 4 and 6 (CDK4 & 6) inhibitor
•-Development of metastatic prostate cancer in the context of castrate levels of testosterone (<=50 ng/dL)
•-Received any prior systemic therapy for metastatic prostate cancer (including investigational agents), the following exceptions are permitted:
•-Up to 3 months of androgen deprivation therapy (ADT) (when given without docetaxel) AND absence of radiographic or prostate specific antigen (PSA) progression prior to randomization
•-Up to 6 cycles of docetaxel with ADT AND absence of radiographic or PSA progression prior to randomization
•-Clinically significant cardiovascular disease as evidenced by myocardial infarction, arterial thrombotic events, or severe/unstable angina in the past 6 months, or New York Heart Association Class II to IV heart failure
•-History of syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin, or sudden cardiac arrest. Chronic and hemodynamically stable atrial arrhythmia well-controlled on medical therapy is permitted
•-Uncontrolled hypertension
•-Clinically active or chronic liver disease, moderate/severe hepatic impairment
•-Known untreated central nervous system (CNS) metastasis. Patients with a history of treated brain metastases are eligible provided that disease is stable following treatment for at least 8 weeks prior to randomization and no requirement for corticosteroid use

发起方

Masaki Takeshi