An Open-label Phase 1b QT/QTc Study of JNJ-56021927 (ARN-509) in Subjects With Castration-Resistant Prostate Cancer. - QT/QTc Study of JNJ-56021927 (ARN-509) in Subjects With Prostate Cancer.

Johnson & Johnson Pharmaceutical0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;- Adenocarcinoma of the prostate; either non-metastatic castrate resistant prostate cancer (NM-CRPC) with high risk disease (defined as PSA Doubling time equal or less than (*) 10 months) or metastatic CRPC;- Be surgically or medically castrated with testosterone levels of <50 ng/dL;- If treated with a gonadotropin releasing hormone analog (ie, patient who has not undergone bilateral orchiectomy), then this therapy must have been initiated at least 4 weeks prior to Cycle 1 Day 1 and must be continued throughout the study;- Electrocardiogram (ECG) showing a QT interval corrected for heart rate, using Fridericia formula (QTcF) * 470 msec (based on the average of a triplicate ECG set collected during the screening visit;- Left ventricular ejection fraction (LVEF) of >45% as determined by multiple uptake gated acquisition (MUGA) or chocardiography at the screening visit

•- Abnormal cardiac function at screening;- Known brain metastases;- Has received an investigational drug within 4 weeks, or within a period less than 10 times the drug*s half-life, whichever is longer, of Cycle 1 Day 1;- Has received chemotherapy or immunotherapy for the treatment of prostate cancer within 4 weeks of Cycle 1 Day 1;- Use of therapies that must be discontinued or substituted within at least 4 weeks priorto Cycle 1 Day 1 including medications to lower seizure threshold, inducing/inhibiting metabolizing enzymes or prolonging the QT interval;- History or condition that may predispose to seizures, or evidence of severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events within 12 months prior to Cycle 1 Day 1, New York Heart Association (NYHA) Class II to IV heart disease

发起方

Johnson & Johnson Pharmaceutical