JPRN-jRCT2031230431招募中1 期
A Phase 1 Clinical Study to Investigate the Safety and Pharmacokinetics of MK-5684 in Japanese Participants with Metastatic Castration-resistant Prostate Cancer (mCRPC)
Koh Yasuhiro0 个研究点目标入组 8 人开始时间: 2023年11月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 8
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
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- Male
入选标准
- •Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology and Have received, or been intolerant to, all treatment known to confer clinical benefit.
- •- Have current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by CT/MRI.
- •- Have ongoing androgen deprivation with serum testosterone <50 ng/dL (<1.7 nmol/L).
- •- Participants receiving bone anti-resorptive therapy must have been on stable doses for >=4 weeks prior to the start of study intervention.
- •- Have progressed on or after treatment with at least 1 line of next generation hormonal agents (NHAs) in metastatic hormone-sensitive prostate cancer (mHSPC) or in CRPC for a minimum of 12 weeks (e.g. abiraterone, enzalutamide, darolutamide, apalutamide), and with at least 1 line of taxane-based chemotherapy in mHSPC or in CRPC, or ineligibility for chemotherapy.
- •- Have prostate cancer progression while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before screening, as determined by the investigator through one of the following:
- •- PSA progression
- •- Radiographic disease progression in soft tissue based on RECIST 1.1, with or without PSA progression
- •- Radiographic disease progression in bone per Prostate Cancer Working Group (PCWG) 3
- •- Have a performance status of 0 or 1 on the ECOG Performance Scale
- •- Have a life expectancy of at least 3 months, based on the investigator assessment.
- •- Have adequate organ function
- •- A male participant is eligible to participate if he agrees to use contraception during the intervention period and for at least 7 days after the last dose of MK-5684.
- •- Participants who have AEs due to previous anticancer therapies must have recovered to <=Grade 1 or baseline.
排除标准
- •- Has a history of pituitary dysfunction.
- •- Has brain metastases.
- •- History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.
- •- Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
- •- Has an active infection or other medical condition that would make corticosteroid contraindicated.
- •- Has serious persistent infection within 2 weeks prior to the start of the study intervention.
- •- Participants on an unstable dose of thyroid hormone therapy within 6 months prior to the start of the study intervention.
- •- Has poorly controlled diabetes mellitus.
- •- Hypotension or uncontrolled hypertension.
- •- Has clinically significant abnormal serum potassium or sodium level.
- •- Has active or unstable cardio/cerebro-vascular disease, including thromboembolic events.
- •- Is unable to swallow orally administered medication or known gastrointestinal (GI) disease or GI procedure that may interfere with absorption of study intervention.
- •- Has undergone major surgery including local prostate intervention (excluding prostate biopsy) within 28 days prior to the start of the study intervention and not adequately recovered from the toxicities and/or complications.
- •- Has received aldosterone antagonist and phenytoin within 4 weeks prior to the start of the study intervention.
- •- Has received radiotherapy within 4 weeks prior to the start of the study intervention, or radiation related toxicities, requiring corticosteroids.
- •- Has received chemotherapy within the last 4 weeks prior to the start of the study intervention.
- •- Has received prior enzalutamide and apalutamide within 3 weeks, or abiraterone and darolutamide within 2 weeks prior to the start of the study intervention.
- •- Has received other anticancer therapy (excluding LHRH agonists or antagonists) within 4 weeks prior to the start of the study intervention, or immune checkpoint inhibitor within 12 weeks prior to the start of the study intervention.
研究者
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