NCT04071262已完成1 期
A Phase 1 Study of Abemaciclib in Combination With Other Anti-Cancer Therapy in Japanese Patients With Advanced Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Number of Participants with Dose Limiting Toxicities (DLTs)
研究概览
简要总结
The purpose of this study is to see if the study drug abemaciclib in combination with other anti-cancer therapies is safe in Japanese participants with advanced cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Participant with histologically confirmed adenocarcinoma of the prostate.
- •Participant with metastatic disease documented by positive bone scan and/or measurable soft tissue metastatic lesions by computed tomography (CT) or magnetic resonance imagining (MRI).
- •Participant who has serum testosterone level is ≤1.73 nanomoles per liter (nmol/L) (50 nanograms per deciliter).
- •Participant who has progressive disease at study entry demonstrated during continuous androgen-deprivation therapy (ADT)/post orchiectomy.
- •Participant with adequate organ function.
- •Participant with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
排除标准
- •Participant who was treated with cytochrome P450 (CYP)17 inhibitors (including abiraterone acetate, TAK-700, TOK-001, and ketoconazole).
- •Participant who was treated with abemaciclib or any cyclin dependent kinase 4 and 6 (CDK4 and 6) inhibitors.
- •Participant who has prior cytotoxic chemotherapy for metastatic castration-resistant prostate cancer (mCRPC), prior radiopharmaceuticals for prostate cancer (PCa), or prior sipuleucel-T.
- •Participant who has gastrointestinal disorder affecting absorption or inability to swallow large pills.
- •Participant who has clinically active or chronic liver disease, moderate/severe hepatic impairment, ascites, or bleeding disorders secondary to hepatic dysfunction.
- •Participant who has known or suspected central nervous system metastatic disease.
- •Participant who was treated with drugs known to be strong inhibitors, or strong or moderate inducers of cytochrome P450 3A4 (CYP3A4) and the treatment cannot be discontinued or switched prior to starting study treatment.
研究组 & 干预措施
Abemaciclib + Abiraterone Acetate + Prednisolone
Experimental
Abemaciclib, abiraterone acetate and prednisolone given orally.
干预措施: Abemaciclib (Drug)
Abemaciclib + Abiraterone Acetate + Prednisolone
Experimental
Abemaciclib, abiraterone acetate and prednisolone given orally.
干预措施: Abiraterone Acetate (Drug)
Abemaciclib + Abiraterone Acetate + Prednisolone
Experimental
Abemaciclib, abiraterone acetate and prednisolone given orally.
干预措施: Prednisolone (Drug)
结局指标
主要结局
Number of Participants with Dose Limiting Toxicities (DLTs)
时间窗: Baseline through Cycle 1 (28 Day Cycle)
Number of Participants with DLTs
次要结局
- Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Abemaciclib in Combination with Abiraterone Acetate plus Prednisolone(Predose Cycle 1 Day 1 through Predose Cycle 3 Day 1 (28 Day Cycles))
- PK: Maximum Concentration (Cmax) of Abemaciclib in Combination with Abiraterone Acetate plus Prednisolone(Predose Cycle 1 Day 1 through Predose Cycle 3 Day 1 (28 Day Cycles))
研究者
研究点 (2)
Loading locations...
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