A Phase 1 interventional study of Apalutamide in Castration-Resistant Prostate Cancer, sponsored by Aragon Pharmaceuticals, Inc.. Completed at 5 sites in 5 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-09.
Sponsored by Aragon Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment
The purpose of this study is to determine whether daily treatment with apalutamide affects the ventricular repolarization in participants with Castration-Resistant Prostate Cancer (CRPC)
This is an open-label (a study in which the drug, procedure is known to participant and investigator), multicenter, Phase 1b study to investigate the effect of apalutamide on ventricular repolarization at a dose level of 240 milligram (mg daily). Approximately 42 participants with high-risk non-metastatic prostate cancer (NM-CRPC), defined as having a prostate specific antigen (PSA) doubling time less than or equal to (\<=) 10 months, or participants with metastatic CRPC will be enrolled. The study consists of a 28-day Screening Phase, a Treatment Phase and a Follow-up Phase. In the Treatment Phase the study drug will be administrated in cycles of 28 days and the participants will be monitored for safety (including cardiac safety) and pharmacokinetics of the study drug. Adverse Events will be monitored throughout the study and in the Follow-up Phase until 30 days after the last dose of study drug. All participants will continue on study until disease progression, withdrawal of consent, lost to follow-up, the occurrence of unacceptable toxicity, the participant is no longer receiving clinical benefit in the opinion of the investigator, or termination of the study by the sponsor. Upon discontinuation of study drug, the participants will return for an End-of-Treatment (EoT) visit no later than 30 days after their last dose. The end of the study corresponds to the clinical cutoff and end of data collection.
6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's enrollment of 45 is below the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Aragon Pharmaceuticals, Inc. is the lead sponsor of 15 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Prostate Cancer participants will receive the study drug on an outpatient basis except for Cycle 1 (Day 1 and Day 2) and Cycle 3 (Day 1), when intake must occur at study site under overnight fasted conditions.
Drug: Apalutamide
Study drug will be administered orally at a dose level of 240 mg daily (4 x 60 mg tablets) in treatment cycles of 28 days.
QTc Fridericia (QTcF) parameter
Mean change from baseline in QTcF as measured based on triplicate electrocardiograms extracted from continuous 12-lead Holter monitor recordings after study drug intake.
Time frame: Day-1 and Day 1 (Cycle 1) and Day 1 (Cycle 3)
Electrocardiographic parameters (HR, RR, PR, and QRS)
A change from time-matched baseline measurements in HR, PR, RR and QRS interval will be determined on Day -1, Day 1 and Day 3
Time frame: Day-1 and Day 1 (Cycle 1) and Day 1 (Cycle 3)
Electrocardiographic parameters (QT)
QT interval on a surface ECG will be corrected for heart rate using Bazett formula (QTcB) and study-specific Power (QTcP) if appropriate at each treatment period.
Time frame: Day-1 and Day 1 (Cycle 1) and Day 1 (Cycle 3)
Electrocardiographic parameters T- and U-wave morphology
Number and percentage of participants with changes from baseline
Time frame: Day-1 and Day 1 (Cycle 1) and Day 1 (Cycle 3)
Plasma concentrations apalutamide (and its active metabolite JNJ-56142060)
Blood samples will be taken following dose administration.
Time frame: Day-1, Day 1 and Day 2 (Cycle 1) and Day 1 (Cycle 3)
Number of participants with Adverse Events
Participants will be monitored for safety during the Screening and Treatment Phases, and up to 30 days after the last dose of study drug. From Cycle 4 onward collection of Adverse Events (AEs) will be limited to Grade 3 or higher and all Serious AEs from the remainder of the study.
Time frame: Day-1, Day 1 and Day 15 (Cycle 1); Day 1 and Day 15 (Cycle 2) and Day 1 (Cycle 3).
Pharmacokinetic parameter area under the plasma drug concentration-time curve (AUC) from time 0 to 24 hours
The AUC(0-24h) is the area under the plasma concentration-time curve from time 0 to time 24 hours after dosing.
Time frame: Day 1 and Day 2 (Cycle 1) and Day 1 (Cycle 3)
Pharmacokinetic parameter maximum concentration observed (Cmax)
The Cmax is the maximum observed plasma concentration.
Time frame: Day 1 and Day 2 (Cycle 1) and Day 1 (Cycle 3)
Pharmacokinetic parameter time to reach Cmax (tmax)
The tmax is the time to reach the maximum observed plasma concentration.
Time frame: Day 1 and Day 2 (Cycle 1) and Day 1 (Cycle 3)
Pharmacokinetic parameter minimum observed plasma concentration (Cmin)
The Cmin is the minimum observed plasma concentration.
Time frame: Cmin will only be collected on Day 1, Cycle 3
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Aragon Pharmaceuticals, Inc.