NCT02445976已完成2 期
A Phase 2 Open-label Study to Evaluate the Efficacy and Safety of Seviteronel in Subjects With Castration-Resistant Prostate Cancer Progressing on Enzalutamide or Abiraterone
Innocrin Pharmaceutical41 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2015年5月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 197
- 试验地点
- 41
- 主要终点
- Proportion of patients who have a PSA response by while on study from starting treatment with seviteronel
研究概览
简要总结
The goal of this clinical study is to determine the efficacy and safety of Seviteronel, a lyase-selective inhibitor of CYP17 and an androgen receptor antagonist, in patients with castration-resistant prostate cancer (CRPC) who have been previously treated with enzalutamide and/or abiraterone.
详细描述
This is a phase 2 clinical trial of Seviteronel (an oral, potent and lyase-selective CYP17 inhibitor) in men with castration-resistant prostate cancer (CRPC) progressing on enzalutamide or abiraterone. Approximately 197 subjects will be used to assess treatment efficacy. The study will be conducted in two different clinical cohorts separated by prior exposure to enzalutamide or abiraterone, or prior exposure to enzalutamide and abiraterone.
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
盲法说明
Open Label
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
- •Subjects must be ≥18 years of age.
- •Subjects or their legal representatives must be able to provide written informed consent.
- •Subjects must have documented histological or cytological evidence of adenocarcinoma of the prostate.
- •Subjects must have an ECOG Performance Score of 0-
- •Subjects must have undergone orchiectomy, or have ongoing LHRH analogue therapy prior to drug initiation. Subjects on LHRH analogues must remain on these agents for the duration of the study.
- •Subjects must have castrate levels of testosterone (≤50 ng/dl [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 C1D
- •Measurable disease is not required for entry. Lymph nodes ≥ 1.5cm (short axis) are considered measurable disease (PCWG3)
- •Bone disease progression defined by ≥2 new lesions on bone scan at Screening, or ≤28 days of C1D1
- •Subjects must 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.
- •Subjects must have 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
- •Subjects must have adequate liver function, including all of 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 ≤2.0 x ULN or ≤5 x ULN in case of bone metastasis and/or hepatic metastasis
- •Subjects must have adequate renal function as evidenced by a serum creatinine of <2.0 mg/dl.
- •Subjects must have potassium (K+) >3.5 mEq/l.
- •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 a Screening and continuing throughout the study period and for 3 months after final study drug administration • Two acceptable forms of birth control include:
- •Condom (barrier method of contraception), and
- •One of the following:
- •Oral, injected or implanted hormonal contraception
- •Placement of an intrauterine device (IUD) or intrauterine system (ISU)
- •Additional barrier methods of contraception: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
- •Vasectomy or surgical castration ≥ 6 months prior to Screening.
- •Subjects able to swallow study medication
- •Subjects able to comply with study requirements
排除标准
- •Subjects who have completed sipuleucel-T (Provenge ®) treatment within 28 days of study drug initiation.
- •Subjects on 5-alpha reductase inhibitors such as finasteride (PROSCAR®, PROPECIA®), or dutasteride (AVODART®) within 28 days of study drug initiation.
- •Subjects who received any investigational agent ≤28 days of study drug initiation.
- •Subjects who received palliative radiotherapy ≤2 weeks of study drug initiation.
- •Subjects with symptomatic CNS metastases.
- •Subjects with a history of another invasive malignancy ≤3 years of study drug initiation.
- •Subjects with 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.
- •Subject with 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)
- •Subject that started a bone modifying agent (e.g. bisphosphonates, denosumab) ≤ 28 days of study drug initiation (note: ongoing bone modifying agents administered > 28 days are allowed).
- •Subject with any medical condition that could preclude subject participation in the study, pose an undue medical hazard, or which could interfere with study results.
- •Subject with Class III or IV Congestive Heart Failure as defined by the New York Heart Association (NYHA) functional classification system within the previous 6 months.
- •Subject with a history of loss of consciousness or transient ischemic attack ≤ 12 months of study drug initiation.
- •Subject with known active HIV, Hepatitis B, or Hepatitis C infections.
- •Subject with known or suspected hypersensitivity to seviteronel, or any components of the formulation
- •Subject with any other condition which in the opinion of the investigator would preclude participation in the study.
研究组 & 干预措施
Prior Abiraterone or Enzalutamide
Experimental
Seviteronel: given orally once daily in 28-day cycles
干预措施: Seviteronel: given orally once daily in 28-day cycles (Drug)
Prior Abiraterone and Enzalutamide
Experimental
Seviteronel: given orally once daily in 28-day cycles
干预措施: Seviteronel: given orally once daily in 28-day cycles (Drug)
结局指标
主要结局
Proportion of patients who have a PSA response by while on study from starting treatment with seviteronel
时间窗: 6 months
PSA response at any time whilst on study from the start of treatment within seviteronel defined by a ≥ 50% decrease in serum PSA.
The time to radiographic disease progression by RECIST 1.1 or PCWG3
时间窗: 10 months
Median time to radiographic disease progression evaluated by computerized tomography (CT scan) or magnetic resonance imaging (MRI) and radionuclide bone scans by RECIST 1.1 or Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
次要结局
未报告次要终点
研究者
研究点 (41)
Loading locations...
相似试验
已完成
2 期
A Study to Evaluate Oral VT-464 in Patients With Castration-Resistant Prostate CancerCastration-resistant Prostate CancerCRPCNCT02012920Innocrin Pharmaceutical200
已完成
2 期
Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non Small Cell Lung Cancer.Non Small Cell Lung CancerNCT00160043Bayer112
尚未招募
1 期
A Study in Subjects With Human Papillomavirus 16 or 18 Associated Cervical Intraepithelial Neoplasia Grade 2 or 3Human Papillomavirus Associated Intraepithelial NeoplasiaCervical Intraepithelial Neoplasia Grade 2/3Human Papillomavirus Type 16 InfectionHuman Papillomavirus Type 18 InfectionNCT06273553RinuaGene Biotechnology Co., Ltd.39
已完成
1 期
CYP17 Lyase and Androgen Receptor Inhibitor Treatment With Seviteronel Trial (INO-VT-464-006; NCT02580448)Cancer of the BreastTriple Negative Breast CancerER+ Breast CancerBreast CancerMetastatic Breast CancerMale Breast CancerAdvanced Breast CancerNCT02580448Innocrin Pharmaceutical175
已完成
2 期
Oral VT-464 in Patients With Castration-Resistant Prostate Cancer Previously Treated With Enzalutamide, Androgen Receptor Positive Triple-Negative Breast Cancer Patients, and Men With ER Positive Breast CancerProstate CancerNCT02130700Innocrin Pharmaceutical17