NCT01549951已完成2 期
A Phase 2, Open-Label, Single-Arm, Multidose Study to Investigate the Effects of Orteronel on the QT/QTc Interval in Patients With Metastatic Castration-Resistant Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Maximum Change From Baseline in QTc Interval Based on the Fridericia Correction (QTcF) Method
研究概览
简要总结
The purpose of this phase 2, open-label, single-arm, multidose, multicenter study is to investigate the effects of Orteronel plus Prednisone on the QT/QTc interval in patients with Metastatic Castration-Resistant Prostrate Cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Voluntary written consent
- •Screening PSA ≥ 2ng/ml
- •Patients must have a diagnosis of mCRPC
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- •Prior surgical or medical castration with testosterone at screening < 50 ng/dL
排除标准
- •Prior chemotherapy for prostate cancer within 6 months prior to screening. (Any prior therapy with cabazitaxel, mitoxantrone, or anthracyclines is exclusionary.)
- •Documented central nervous system metastases
- •Clinically significant heart disease
- •Patients who have an abnormal 12-lead ECG result at screening including one or more of the following: QRS>110 ms, QTcF>480ms, PR interval>200 ms
- •Patients who have a history of risk factors for TdP including unexplained syncope, known long QT syndrome, heart failure, angina, or clinically significant abnormal laboratory assessments
- •Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
- •Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons
研究组 & 干预措施
Orteronel+Prednisone
Experimental
干预措施: Orteronel+Prednisone (Drug)
结局指标
主要结局
Maximum Change From Baseline in QTc Interval Based on the Fridericia Correction (QTcF) Method
时间窗: Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose
Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 1 minute) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Results of change in QTcF analyzed from 12-lead ECGs performed at each time point were averaged for analysis and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.
次要结局
- Changes From Baseline in Heart Rate(Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose)
- Maximum Change From Baseline in QTc Based on the Bazett Correction (QTcB) Method, PR, QRS and Uncorrected QT Interval(Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose)
- AUC(0-6): Area Under the Plasma Concentration-Time Curve From Time 0 to 6 Hours Postdose for Orteronel and M-I Metabolite(Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose)
- Number of Participants Reporting Change From Baseline in ECG Morphology(Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose)
- Correlation Between the QTcF Change From Baseline and Plasma Concentrations of Orteronel(Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose)
- Number of Participants Reporting One or More Treatment-emergent Adverse Events(Baseline up to 30 days after last dose of study drug (Day 86))
- Number of Participants Reporting Clinically Significant Abnormalities in Laboratory Values(Baseline up to 30 days after last dose of study drug (Day 86))
- Number of Participants Reporting Clinically Significant Abnormalities in Vital Signs(Baseline up to 30 days after last dose of study drug (Day 86))
- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Orteronel and M-I Metabolite(Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose)
- Cmax: Maximum Observed Plasma Concentration for Orteronel and M-I Metabolite(Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose)
- Number of Participants Reporting Clinically Significant Abnormalities in Physical Findings(Baseline up to 30 days after last dose of study drug (Day 86))
- Number of Participants Reporting Clinically Significant Abnormalities in ECG(Baseline up to 30 days after last dose of study drug (Day 86))
研究者
研究点 (1)
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