NCT01317641已完成1 期
Safety and Pharmacokinetics of ODM-201 in Patients With Castrate Resistant Prostate Cancer: Open, Non-randomised, Uncontrolled, Multicentre, Multiple Dose Escalation Study With a Randomised Phase II Expansion Component
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
- 136
- 试验地点
- 23
- 主要终点
- Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT)
研究概览
简要总结
The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of ODM-201 in patients with castrate resistant prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Histologically confirmed adenocarcinoma of prostate
- •Ongoing androgen deprivation therapy with a LHRH analogue or antagonist or bilateral orchiectomy
- •Progressive metastatic disease
- •Adequate bone marrow, hepatic, and renal function
排除标准
- •Known metastases in the brain
- •History of other malignancy within the previous 5 years
- •Known gastrointestinal disease or procedure that affects the absorption
- •Not able to swallow the study drug
研究组 & 干预措施
ODM-201 Phase II Dose 2
Experimental
干预措施: ODM-201 (Drug)
ODM-201 Phase I
Experimental
干预措施: ODM-201 (Drug)
ODM-201 Phase II Dose 1
Experimental
干预措施: ODM-201 (Drug)
ODM-201 Phase II Dose 3
Experimental
干预措施: ODM-201 (Drug)
结局指标
主要结局
Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT)
时间窗: Up to 28 days for each cohort
A DLT was any Grade 3 or more toxicity (by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE version 4.03\]) excluding less than Grade 4 neutropenia or thrombocytopenia, hematological toxicity lasting less than 7 days, and nausea, vomiting, diarrhea controlled with antiemetic and/or anti-diarrheal treatment.
Phase 1: Number of Dose Limiting Toxicities Used to Determine the Maximum Tolerated Dose
时间窗: Up to 28 days for each cohort
The MTD is defined as dose level at which 2 or more out of 6 participants experience a dose limiting toxicity (DLT)
次要结局
- Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Chemotherapy-naïve and CYP17i-naïve Group(3 months)
- Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-chemotherapy and CYP17i-naïve Group(3 months)
- Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-CYP17i Group(3 months)
- Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group(3 months)
- Phase 1 and 2: Participants With RECIST Responses in Soft Tissue in Post-CYP17i Group(3 months)
- Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of ODM-201 at Steady-state(Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose)
- Phase 1: Maximum Plasma Concentration (Cmax) of ODM-201 at Steady-state(Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose)
- Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of ODM-201 at Day 1(1 day)
- Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of Major Metabolite ORM-15341 at Steady-state(Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose)
- Phase 1: Maximum Plasma Concentration (Cmax) of Major Metabolite ORM-15341 at Steady-state(Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose)
- Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of Major Metabolite ORM-15341 at Day 1(1 day)
- Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group(3 months)
- Phase 1 and 2: Participants With Stable Bone Disease in Chemotherapy-naïve and CYP17i-naïve Group(3 months)
- Phase 1 and 2: Participants With Stable Bone Disease in Post-chemotherapy and CYP17i-naïve Group(3 months)
- Phase 1 and 2: Participants With Stable Bone Disease in Post-CYP17i Group(3 months)
研究者
研究点 (23)
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SAFETY, ABSORPTION AND DISTRIBUTION OF ODM-201 IN PATIENTS WITH PROSTATE CANCER:Progressive castration resistant prostate cancer (MedDRA: hormone-refractory prostate cancer)MedDRA version: 14.1Level: LLTClassification code 10062904Term: Hormone-refractory prostate cancerSystem Organ Class: 100000004864EUCTR2010-022802-41-EEOrion Corporation Orion Pharma130
进行中（未招募）
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SAFETY, ABSORPTION AND DISTRIBUTION OF ODM-201 IN PATIENTS WITH PROSTATE CANCER:Progressive castration resistant prostate cancer (MedDRA: hormone-refractory prostate cancer)MedDRA version: 14.1Level: LLTClassification code 10062904Term: Hormone-refractory prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-022802-41-GBOrion Corporation Orion Pharma