Apalutamide for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Prostate Cancer+1 More
Apalutamide - Drug
Eligibility
18+
Male
What conditions do you have?
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Study Summary

This trial will study whether apalutamide affects heart function in men with CRPC.

Eligible Conditions
  • Prostate Cancer
  • Malignant neoplasm of prostate

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Day-1, Day 1 and Day 15 (Cycle 1); Day 1 and Day 15 (Cycle 2) and Day 1 (Cycle 3).

Day 1
Pharmacokinetic parameter minimum observed plasma concentration (Cmin)
Day 2
Pharmacokinetic parameter area under the plasma drug concentration-time curve (AUC) from time 0 to 24 hours
Pharmacokinetic parameter maximum concentration observed (Cmax)
Pharmacokinetic parameter time to reach Cmax (tmax)
Day 1
Electrocardiographic parameters (HR, RR, PR, and QRS)
Electrocardiographic parameters (QT)
Electrocardiographic parameters T- and U-wave morphology
QTc Fridericia (QTcF) parameter
Day 15
Number of participants with Adverse Events
Day 2
Plasma concentrations apalutamide (and its active metabolite JNJ-56142060)

Trial Safety

Side Effects for

Arm B (LHRHa, Apalutamide, Abiraterone Acetate)
74%Hot flashes
71%Fatigue
44%Anemia
38%Hyperglycemia
26%AST increase
26%Hypertension
26%Lipase increase
24%Dry skin
24%ALT increase
21%Rash
18%Cholesterol high
18%ACTH increase
15%Amylase increase
15%Dizziness
12%Constipation
12%White blood cell decrease
12%Memory impairment
12%Lymphocyte count decrease
9%Myalgia
9%Paresthesia
9%Weight loss
9%Hypothyrodism
9%LDH increase
9%Arthralgia
6%Irritability
6%Headache
6%Dysgeusia
6%HbA1c increased
6%Hypertriglyceridemia
6%Dyspnea
6%Personality change
6%Erectile dysfunction
6%Insomnia
3%TSH increased
3%Bruising
3%Hypercalcemia
3%Dehydration
3%Atrial fibrillation
3%Anxiety
3%Anorexia
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT03279250) in the Arm B (LHRHa, Apalutamide, Abiraterone Acetate) ARM group. Side effects include: Hot flashes with 74%, Fatigue with 71%, Anemia with 44%, Hyperglycemia with 38%, AST increase with 26%.

Trial Design

1 Treatment Group

Apalutamide
1 of 1

Experimental Treatment

45 Total Participants · 1 Treatment Group

Primary Treatment: Apalutamide · No Placebo Group · Phase 1

Apalutamide
Drug
Experimental Group · 1 Intervention: Apalutamide · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apalutamide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day-1, day 1 and day 15 (cycle 1); day 1 and day 15 (cycle 2) and day 1 (cycle 3).

Who is running the clinical trial?

Aragon Pharmaceuticals, Inc.Lead Sponsor
16 Previous Clinical Trials
5,332 Total Patients Enrolled
5 Trials studying Prostate Cancer
1,284 Patients Enrolled for Prostate Cancer
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
707 Previous Clinical Trials
3,900,099 Total Patients Enrolled
7 Trials studying Prostate Cancer
2,688 Patients Enrolled for Prostate Cancer

Eligibility Criteria

Age 18+ · Male Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are surgically or medically castrated with testosterone levels of less than 50 nanogram per deciliter.
You have 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).
You have a performance status score of 0 or 1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 10th, 2021

Last Reviewed: November 27th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.