EUCTR2011-004103-20-GB进行中（未招募）1 期
A Phase 1/2 Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Seviteronel in Subjects with Castration-Resistant Prostate Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 135
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1.=18 years of age
- •2.Able to provide written informed consent or have their legal representatives provide written informed consent
- •3.Documented histological or cytological evidence of adenocarcinoma of the prostate. Subjects whose pathology reports are no longer available may be enrolled if, in the opinion of the investigator, the subject has a clinical course consistent with prostatic adenocarcinoma
- •4.ECOG Performance Status of 0 or 1
- •5.Undergone orchiectomy, or have ongoing LHRH analogue therapy prior to C1D1. Subjects on LHRH analogues should remain on these agents for the duration of the study
- •6.Castrate levels of testosterone =50 ng/dl (or 1.7 nmol/L) and have progressive disease at Screening defined as PSA rise determined by a minimum of 2 rising PSA values = 1 week between each assessment. The PSA value at the Screening visit must be = 2ng/mL with or without:
- •Soft tissue disease progression defined by RECIST 1.1 at Screening or = 28 days of C1D1. Measurable disease is not required for entry. Lymph nodes = 1.5cm (short axis) are considered measurable disease (PCWG3, Scher 2016)
- •Bone disease progression defined by =2 new lesions on bone scan at Screening, or = 28 days of C1D1
- •7.Have received abiraterone and/or enzalutamide. Subject must have received either abiraterone or enzalutamide for =12 weeks. Other second generation CYP17 inhibitors/androgen receptor antagonists including but not limited to TAK-700 (orteronel), TOK-001 (galeterone) may have been taken in place of abiraterone and ARN-509 (apalutamide) may have been taken in place of enzalutamide.
- •8.Adequate hematopoietic function as evidenced by:
- •WBC = 3,000/µl
- •ANC = 1,500/µl
- •Platelet count = 100,000/µl
- •HGB = 10 g/dl and not transfusion dependent
- •9.Adequate liver function, including all the following:
- •Total serum bilirubin =2.0 x ULN unless the subject has documented Gilbert syndrome;
- •Aspartate and alanine aminotransferase (AST & ALT) =3.0 x ULN or =5.0 x ULN if subject has liver metastasis;
- •Alkaline phosphatase =3.0 x ULN or =5 x ULN in case of bone metastasis and/or hepatic metastasis
- •10.Subjects must have adequate renal function as evidenced by a serum creatinine of =2.0 mg/dl
- •11.Potassium (K+) =3.5 mEq/l
- •12.Subject and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at Screening and continuing throughout the study period and for 3 months after final study drug administration
- •13.Able to swallow study medication
- •14.Able to comply with study requirements
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 31
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 123
排除标准
- •1.Received sipuleucel-T (Provenge ®) treatment within 28 days of C1D1
- •2.Received 5-alpha reductase inhibitors such as finasteride (PROSCAR®, PROPECIA®), or dutasteride (AVODART®) within 28 days of C1D1
- •3.Received any investigational agent = 28 days of C1D1
- •4.Received palliative radiotherapy = 2 weeks of C1D1
- •5.Symptomatic CNS metastases
- •6.History of another invasive malignancy = 3 years of C1D1
- •7.A QTcF interval of > 470 msec; if the Screening ECG QTcF interval is > 470 msec, it may be repeated, and if repeat < 470 msec, the subject may be enrolled
- •8.Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes, second degree or third degree atrioventricular heart block without a permanent pacemaker in place)
- •9.Started a bone modifying agent (e.g. bisphosphonates, denosumab) = 28 days of C1D1 (note: ongoing bone modifying agents administered > 28 days are allowed)
- •10.Any medical condition that could preclude subject participation in the study, pose an undue medical hazard, or which could interfere with study results
- •11.Class III or IV Congestive Heart Failure (CHF) as defined by the New York Heart Association (NYHA) functional classification system within the previous 6 months
- •12.A history of loss of consciousness or transient ischemic attack = 12 months of C1D1
- •13.Known active HIV, Hepatitis B, or Hepatitis C infections
- •14.Known or suspected hypersensitivity to seviteronel, or any components of the formulation
- •15.Any other condition which in the opinion of the investigator would preclude participation in the study
研究者
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