prostate cancer
Conditions
Interventions
The study will consist of a 28-day screening, a treatment and a follow-up phase.
During the screening the investigator determines whether the patient is
eligible to participate in the study.
During
Sponsors
Johnson & Johnson Pharmaceutical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 45% as determined by multiple uptake gated acquisition (MUGA) or chocardiography at the screening visit
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to evaluate the effects of JNJ-56021927 and its active metabolite JNJ-56142060 on ventricular repolarization (QTcF) by using time-matched ECGs at baseline and on study drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To evaluate the effect of JNJ-56021927 on other ECG parameters (HR, QT interval, Bazett*s QT correction [QTcB] interval, QT interval using study-specific Power [QTcP], RR interval, PR interval, QRS interval, T-wave morphology, and U-wave morphology). - To evaluate the pharmacokinetics of JNJ-56021927 and its active metabolite, JNJ-56142060. - To determine the potential relationship between the plasma concentrations of JNJ-56021927, JNJ-56142060, and QTcF. - To evaluate the safety of JNJ-56021927. | — |
Countries
Netherlands
Outcome results
None listed