NCT03778047已完成1 期
A Clinical Study for Evaluating Enzalutamide Pharmacokinetics and Pharmacodynamics, and Related Changes After Drug Switch in Chinese 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
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Maximum drug concentration(Cmax)
研究概览
简要总结
This is a study for evaluating enzalutamide pharmacokinetics and pharmacodynamics, and related changes after drug switch in Chinese patients with metastatic castration-resistant prostate cancer. The study primary objective is to evaluate the pharmacokinetic characteristics of enzalutamide in Chinese patients with mCRPC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Voluntarily participated in the study, with understanding of and will to comply with relevant study procedures and signed informed consent form;
- •Chinese male, ≥ 18 years old;
- •With histologically or cytologically confirmed prostate cancer, without neuroendocrine carcinoma or ductal adenocarcinoma;
- •With evidence of metastatic lesions (such as bone scan and CT/MRI);
- •Patients with relapsed, refractory, or progressive disease despite castration (surgery or chemical) or combined androgen deprivation therapy. (Progressive disease is defined as 1 or more of the following 3 criteria: PSA progression: A minimum of 3 rising PSA values with an interval of at least 1 week between determinations, resulting in a final value higher than 50% of the minimum, with a starting PSA value > 2 ng/ml; Soft tissue disease progression as defined by RECIST 1.1; Bone progression as defined by PCWG2 with 2 or more new lesions on bone scan);
- •Castrate levels of testosterone (< 50 ng/dl) at screening; bilateral orchiectomy or ongoing androgen deprivation therapy with effective GnRH analogues;
- •ECOG performance status ≤1;
- •Laboratory tests must meet the following criteria:
- •Routine Blood Test: hemoglobin (Hb) ≥ 90g/L (no blood transfusions within 14 days prior to screening); absolute neutrophil count (ANC) ≥ 1.5 x 109/L; Platelet Count (PLT) ≥ 80 x 109/L;
- •Blood Biochemistry: creatinine (Cr) ≤ 2 x upper limit of normal (ULN), or Cr > 2 x ULN but the calculated CrCl ≥ 60 ml/min; bilirubin (BIL) ≤2 x ULN; alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤2.5 x ULN (or ≤ 5.0 x ULN for patients with liver metastases);
- •Coagulation: INR < 1.
- •Estimated life expectancy > 6 months.
排除标准
- •Participated in other clinical drug trials within 1 month prior to screening, or the occurrence of toxicity caused by previous treatments that has not been relieved to ≤ Grade 2 toxicity (according to CTCAE 4.03) prior to enrollment;
- •Brain metastases;
- •Subjects are excluded if any of the following conditions are met:
- •Other malignancies within the last 5 years (except for curatively treated non-melanoma skin cancer);
- •History of organ transplants;
- •Past medical history of seizures, serious CNS diseases, or unexplained coma, family history of seizures, or history of traumatic brain injury;
- •Uncontrolled hypertension (systolic ≥ 160 mmHg or diastolic ≥ 100 mmHg) or other serious cardiovascular diseases. (Patients with a history of hypertension is eligible if his blood pressure is controlled with antihypertensives);
- •Significant GI dysfunction which may affect the intake, transport, or absorption of drug (such as inability to swallow, chronic diarrhea, and bowel obstruction, etc.), or patients with complete gastrectomy;
- •Other uncontrolled clinical diseases, including but not limited to: persistent or active infections.
- •Subjects are excluded if any of the following conditions regarding past or concomitant medication are met:
- •Medications that lower the seizure threshold must be used during the trial;
- •Treatment with 5α-reductase inhibitors (finasteride, dutasteride), estrogen, or cyproterone within 4 weeks prior to screening;
- •Treatment with ketoconazole within 4 weeks prior to screening;
- •Previously treated with investigational or approved medications that inhibit testosterone synthesis (such as abiraterone acetate, TAK-683, and TAK-448) or target testosterone receptors (such as SHR3680, proxalutamide, and ARN509), except for bicalutamide and flutamide.
- •Known hypersensitivity to any ingredient of the study drugs (enzalutamide and HC-1119) or similar drugs;
- •HIV seropositive;
- •History of medication or drug abuse;
- •Other conditions that subject is determined by the investigator to be unsuitable for this study.
研究组 & 干预措施
enzalutamide
Experimental
160mg
干预措施: Enzalutamide (Drug)
HC-1119
Experimental
To be determined
干预措施: HC1119 (Drug)
结局指标
主要结局
Maximum drug concentration(Cmax)
时间窗: From the first dose of the study drug to 12 weeks after dose
Area under curve from time 0 to 24h (AUC0-24h)
时间窗: From the first dose of the study drug to 12 weeks after dose
Time of maximum drug concentration(Tmax)
时间窗: From the first dose of the study drug to 12 weeks after dose
次要结局
- Maximum drug concentration(Cmax)(From 13 weeks to 24 weeks after dose)
- Time of maximum drug concentration(Tmax)(From 13 weeks to 24 weeks after dose)
- Number of patients with adverse events(From the first dose of the study drug to 24 weeks after dose)
- Area under curve from time 0 to 24h (AUC0-24h)(From 13 weeks to 24 weeks after dose)
- Percentage of patients with > 50% decrease in prostate specific antigen (PSA)(From the first dose of the study drug to 12 weeks after dose)
研究者
研究点 (1)
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