NCT02344017已完成1 期
Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC): Open, Non-Randomised, Uncontrolled, Multicentre, Dose Escalation, First-in-man Study With a Dose Expansion
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
- 23
- 试验地点
- 4
- 主要终点
- Safety and tolerability assessed by incidence of adverse events
研究概览
简要总结
The purpose of this first-in-man study is to evaluate safety, tolerability and pharmacokinetics of ODM-204 in patients with metastatic castration-resistant prostate cancer.
详细描述
The safety profile of ODM-204 will be explored together with the pharmacokinetics, pharmacodynamics and tumour response to treatment with ODM-204 to recommend the dosing regimen for further clinical studies. The pharmacokinetic properties of ODM-204 will be evaluated after single and multiple dose administrations at different dose levels.
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
- •Written informed consent (IC) obtained.
- •Male aged ≥ 18 years.
- •Histologically or cytologically confirmed adenocarcinoma of prostate.
- •Ongoing GnRH agonist or antagonist therapy, or after bilateral orchiectomy.
- •Progressive metastatic disease
- •Adequate bone marrow, hepatic, and renal function
- •Acceptable and regular bowel movements without any GI disorder or procedure which may interfere with absorption of study treatment
- •Ability to swallow study treatments
排除标准
- •History of pituitary or adrenal dysfunction.
- •Known brain metastases.
- •Active infection or other medical condition that would make prednisone (corticosteroid) contraindicated.
- •Uncontrolled hypertension
- •Clinically significant heart disease
- •Prolonged QTc interval
研究组 & 干预措施
ODM-204 Phase I dose escalation
Experimental
Dose escalation
干预措施: ODM-204 (Drug)
ODM-204 Phase I dose escalation
Experimental
Dose escalation
干预措施: Prednisone (Drug)
ODM-204 Phase II dose expansion
Experimental
干预措施: ODM-204 (Drug)
ODM-204 Phase II dose expansion
Experimental
干预措施: Prednisone (Drug)
结局指标
主要结局
Safety and tolerability assessed by incidence of adverse events
时间窗: Until disease progression, an expected average of 6 months
Safety and tolerability assessed by vitals signs and 12-lead ECG
时间窗: Until disease progression, an expected average of 6 months
Safety and tolerability assessed by laboratory assessments
时间窗: Until disease progression, an expected average of 6 months
次要结局
- Pharmacokinetic profile assessed by time to reach peak concentration (tmax)(0 - week 12)
- Preliminary antitumour activity assessed by prostate specific antigen (PSA) response(Until disease progression, an expected average of 6 months)
- Pharmacokinetic profile assessed by plasma peak concentration (Cmax)(0 - week 12)
- Pharmacokinetic profile assessed by area under the concentration-time curve (AUC)(0 - week 12)
- Preliminary antitumour activity assessed by response in soft and bone tissues(Until disease progression, an expected average of 6 months)
- Pharmacodynamic profile assessed by hormone and circulating tumour cell measurements(0 - week 12)
研究者
研究点 (4)
Loading locations...
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