PER-047-23尚未招募3 期
Phase 3, Randomized, Open-Label Study of MK-5684 Versus Alternative Treatment With Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) That Progressed During or After Prior Treatment With an Agent new generation hormonal (NHA)
Merck Sharp & Dohme LLC., (una subsidiaria de Merck & Co. Inc.)0 个研究点目标入组 0 人开始时间: 2024年6月18日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Participant type and disease characteristics
- •Has histologically or cytologically confirmed prostate adenocarcinoma without small cell histology (if acceptable according to local health authority regulations). The diagnosis must be established in a pathology report and confirmed by the investigator.
- •Participant type and disease characteristics
- •Has prostate cancer progression while receiving ADT (or after bilateral orchiectomy) within 6 months prior to screening. The investigator will determine prostate cancer progression using 1 of the following:
- •PSA progression based on local laboratory values, defined as a minimum of 2 consecutive rising PSA levels with an interval of =1 week between each assessment, where PSA at screening should be =1 ng/ml. See Section 8.2.2 for additional information.
- •Note: A PSA level obtained during the screening period may count as the second confirmatory rising PSA.
- •Radiographic progression of the disease in soft tissues according to RECIST 1.1, with or without PSA progression.
- •Radiographic disease progression in bone according to PCWG, defined as the appearance of 2 or more new bone lesions on bone imaging with or without PSA progression.
- •Participant type and disease characteristics
- •Has disease progression under the following conditions if the participant received first-generation antiandrogen therapy prior to screening:
- •Evidence of progression >4 weeks since last flutamide treatment.
- •Evidence of progression >6 weeks since last treatment with bicalutamide or nilutamide.
- •Participant type and disease characteristics
- •Has current evidence of metastatic disease documented by bone lesions on bone imaging and/or soft tissue disease visible on CT/MRI.
- •Participant type and disease characteristics
- •You have disease that has progressed during or after treatment with an NHA (e.g., abiraterone acetate, enzalutamide, apalutamide, darolutamide) for HSPC (mHSPC or nmHSPC), or nmCRPC, for at least 8 weeks ( at least 14 weeks for participants with bone progression).
- •Note: Participants may have received abiraterone acetate and docetaxel or darolutamide and docetaxel for HSPC. However, participants must have received no more than 6 cycles of docetaxel and must not have had radiographic disease progression while receiving docetaxel.
- •Participant type and disease characteristics
- •Have received prior treatment with PARPi or have been deemed unsuitable for treatment by the investigator or have refused treatment with PARPi.
- •Participant type and disease characteristics
- •Has ongoing ADT with serum testosterone <50 ng/dl (<1.7 nM). If the participant is currently being treated with luteinizing hormone-releasing hormone agonists or antagonists (in participants who have not had an orchiectomy), this treatment must have been started at least 4 weeks before the randomization date and the Treatment should continue throughout the study.
排除标准
- •Medical conditions
- •Has a gastrointestinal condition; for example, malabsorption, which may affect the absorption of the study medication.
- •Medical conditions
- •Cannot swallow capsules/tablets.
- •Medical conditions
- •History of pituitary dysfunction.
- •Note: Exceptions may be considered after consulting Sponsor.
- •Medical conditions
- •Poorly controlled diabetes mellitus.
- •Medical conditions
- •Clinically significant abnormal serum potassium or sodium level.
- •Medical conditions
- •You present any of the following symptoms at the screening visit:
- •Hypotension: for systolic <110 mmHg; or
- •Uncontrolled hypertension: for systolic =160 mmHg or for diastolic =90 mmHg, in 2 of 3 records with optimized antihypertensive treatment.
- •Medical conditions
- •Have active or unstable cardiovascular or cerebrovascular disease, including thromboembolic events.
- •Examples: recent myocardial infarction (within 6 months), coronary artery bypass graft, or symptomatic stroke or congestive heart failure (New York Heart Association class III-IV).
- •Medical conditions
- •History or family history of long QTc syndrome.
- •Medical conditions
- •Has a resting ECG that indicates unmonitored and possibly reversible cardiac conditions at the discretion of the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation >470 ms, electrolyte disturbances, etc.) or have congenital long QT syndrome.
- •Medical conditions
- •Have a history of seizures within 6 months prior to providing documented informed consent or have a condition that could predispose you to seizures within 12 months prior to the date of enrollment, including, but not limited to, loss of consciousness or previous stroke, transient ischemic attack or cerebral arteriovenous malformation, or intracranial tumor, such as schwannoma or meningioma, that is causing edema or mass effect.
- •Medical conditions
- •You have a history of clinically significant ventricula
研究者
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