NCT03436485进行中（未招募）1 期
Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 204
- 试验地点
- 24
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
The purpose of this first-in-man study is to evaluate safety and tolerability of ODM-208 in patients with metastatic castration-resistant prostate cancer.
详细描述
Safety and tolerability profile of ODM-208 will be explored
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Written informed consent (IC) obtained.
- •Male aged ≥ 18 years.
- •Histologically confirmed adenocarcinoma of the prostate.
- •Castration resistant prostate cancer with serum testosterone < 50 ng/dl.
- •Metastatic disease.
- •Ongoing androgen deprivation therapy with GnRH analogue or antagonist, or have had bilateral orchiectomy.
- •Received at least one prior line of novel hormonal androgen receptor (AR) targeted therapy (e.g. abiraterone, enzalutamide).
- •ECOG performance status 0-
- •Adequate marrow, liver and kidney function.
- •Able to swallow study treatment.
- •Part 1: Treatment with at least 1 line of chemotherapy or ineligibility for chemotherapy. Part 2: Treatment with at least 1 line of taxane-based chemotherapy in castration-sensitive prostate cancer (CSPC) or in CRPC.
排除标准
- •History of pituitary or adrenal dysfunction.
- •Known brain metastases or active leptomeningeal disease.
- •Active infection or other medical condition that would make corticosteroid contraindicated.
- •Poorly controlled diabetes.
- •Hypotension or uncontrolled hypertension.
- •Clinically significantly abnormal serum potassium or sodium level.
- •Active or unstable cardio/cerebro-vascular disease including thromboembolic events.
- •Prolonged QTcF interval.
研究组 & 干预措施
ODM-208 Part 1 Dose escalation
Experimental
干预措施: ODM-208 (Drug)
ODM-208 Part 2 Drug drug interaction
Experimental
干预措施: ODM-208 (Drug)
ODM-208 Part 2 Dose expansion
Experimental
干预措施: ODM-208 (Drug)
ODM-208 Part 2 Drug drug interaction
Experimental
干预措施: Midazolam (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: Within first 28 days of treatment
Highest dose level at which under 33% of patients in a cohort experience DLT
次要结局
未报告次要终点
研究者
研究点 (24)
Loading locations...
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