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

Completed

Conditions: prostate cancer
10036958

Registration Number: NL-OMON47113

Lead Sponsor: Johnson & Johnson Pharmaceutical

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

- 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

Exclusion Criteria

- 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is to evaluate the effects of JNJ-56021927<br /><br>and its active metabolite JNJ-56142060 on ventricular repolarization (QTcF) by<br /><br>using time-matched ECGs at baseline and on study drug.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To evaluate the effect of JNJ-56021927 on other ECG parameters (HR, QT<br /><br>interval, Bazett*s QT correction [QTcB] interval, QT interval using<br /><br>study-specific Power [QTcP], RR interval, PR interval, QRS interval, T-wave<br /><br>morphology, and U-wave morphology).<br /><br>- To evaluate the pharmacokinetics of JNJ-56021927 and its active metabolite,<br /><br>JNJ-56142060.<br /><br>- To determine the potential relationship between the plasma concentrations of<br /><br>JNJ-56021927, JNJ-56142060, and QTcF.<br /><br>- To evaluate the safety of JNJ-56021927.</p><br>