A JNJ-56021927 (ARN-509; Apalutamide) QT/QTc Study

NCT02578797 | Completed Phase 1

• 3 other identifiers: CR1080492015-004044-1956021927PCR1019
• Study Type: interventional
• Target: 45
• Locations: 5 countries
• Sites: 5

Brief Summary

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)

Conditions

Castration-Resistant Prostate Cancer

Keywords

Castration-Resistant Prostate Cancer (CRPC); Prostatic Neoplasms; Genital Diseases, Male; Genital Neoplasms, Male; Neoplasms; Neoplasms by Site; Prostatic Diseases; Urogenital Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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.

  Day-1 and Day 1 (Cycle 1) and Day 1 (Cycle 3)

Secondary Outcomes (9)

• Electrocardiographic parameters (HR, RR, PR, and QRS)

  Day-1 and Day 1 (Cycle 1) and Day 1 (Cycle 3)

• Electrocardiographic parameters (QT)

  Day-1 and Day 1 (Cycle 1) and Day 1 (Cycle 3)

• Electrocardiographic parameters T- and U-wave morphology

  Day-1 and Day 1 (Cycle 1) and Day 1 (Cycle 3)

• Plasma concentrations apalutamide (and its active metabolite JNJ-56142060)

  Day-1, Day 1 and Day 2 (Cycle 1) and Day 1 (Cycle 3)

• Number of participants with Adverse Events

  Day-1, Day 1 and Day 15 (Cycle 1); Day 1 and Day 15 (Cycle 2) and Day 1 (Cycle 3).

Study Arms (1)

Apalutamide

EXPERIMENTAL

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

Interventions

Apalutamide DRUG

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.

Apalutamide

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 less than (\<) 50 nanogram per deciliter
• 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 milliseconds (based on the average of a triplicate ECG set collected during the screening visit)
• Left ventricular ejection fraction (LVEF) of more than 45% as determined by multiple uptake gated acquisition (MUGA) or echocardiography at the screening visit

You may not qualify if:

• Abnormal cardiac function at screening
• Known brain metastases
• Has received an investigational drug within 4 weeks, or within a period \< 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
• Prior treatment with enzalutamide and apalutamide
• Use of therapies that must be discontinued or substituted within at least 4 weeks prior to 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

Sponsors & Collaborators

• Aragon Pharmaceuticals, Inc.: lead

Study Sites (5)

Unknown Facility

Greenville, South Carolina, United States

Location

Unknown Facility

Montreal, Quebec, Canada

Location

Unknown Facility

Chisinau, Moldova

Location

Unknown Facility

Rotterdam, Netherlands

Location

Unknown Facility

Sutton, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Genital Diseases, Male; Genital Neoplasms, Male; Neoplasms; Neoplasms by Site; Prostatic Diseases; Urogenital Neoplasms

Interventions

apalutamide

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: October 19, 2015
• Study Start: December 18, 2015
• Primary Completion: September 20, 2016
• Study Completion: October 13, 2022
• Last Updated: November 9, 2023

Record last verified: 2023-11

Locations

US (1); MO (1); NL (1); GB (1); CA (1)