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Hormone Therapy

Niraparib + Abiraterone for Prostate Cancer

Phase 1
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to continue gonadotropin-releasing hormone analogues (GnRHa) therapy during the study if not surgically castrate (that is, participants who have not undergone bilateral orchiectomy)
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of less than or equal to (<=) 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study start until study completion (up to 3.1 years)
Awards & highlights

Summary

This trial is testing different strengths and formulations of niraparib and abiraterone acetate to see how well they are absorbed by the body.

Who is the study for?
Men with metastatic castration-resistant prostate cancer (mCRPC) who may benefit from the study treatments. Participants should be able to continue hormone therapy if not surgically castrated, have a performance status indicating they are relatively active and can care for themselves, and must provide a tumor sample for genetic testing.
What is being tested?
The trial is examining different strengths and formulations of Niraparib and Abiraterone Acetate (AA) under modified fasted conditions to see how well the body absorbs them in men with mCRPC. The study has multiple periods to assess relative bioavailability and bioequivalence.
What are the potential side effects?
Potential side effects include fatigue, nausea, vomiting, anemia, low blood counts leading to increased infection risk or bleeding problems, liver function changes, joint pain or swelling, high blood pressure, hot flushes or skin rash.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can continue hormone therapy during the study if I haven't had surgery to remove my testicles.
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I am fully active or have some restrictions but can still care for myself.
Select...
My prostate cancer was confirmed by a lab test.
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I am willing to give a sample of my tumor for genetic testing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study start until study completion (up to 3.1 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from study start until study completion (up to 3.1 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area Under the Plasma Concentration-time Curve from Time Zero to 24 Hours at Steady State (AUC [0-24h],ss) of Niraparib and AA (Period 2 and Period 3)
Maximum Observed Analyte Concentration at Steady State (Cmax,ss) of Niraparib and Abiraterone Acetate (AA) [Period 2 and Period 3]
Ratio of Individual Cmax,ss Values Between Test and Reference Treatment (Period 2 and Period 3)
+1 more
Secondary study objectives
Area Under the Plasma Concentration-time Curve from Time Zero to 72 Hours (AUC [0-72h]) of Niraparib and AA (Period 1)
Maximum Observed Analyte Concentration at (Cmax) of Niraparib and AA (Period 1)
Number of Participants with AEs by Severity
+4 more

Side effects data

From 2022 Phase 2 trial • 37 Patients • NCT03207347
74%
Fatigue
52%
Nausea
39%
Constipation
39%
Anorexia
30%
Anemia
30%
Alkaline phosphatase increased
26%
Weight loss
22%
Dizziness
22%
Dyspnea
22%
Insomnia
22%
Abdominal pain
17%
Headache
17%
Mucositis oral
17%
Platelet count decreased
17%
Creatinine increased
13%
Vomiting
13%
Aspartate aminotransferase increased
13%
Rash maculo-papular
13%
Sinus tachycardia
9%
Urinary tract infection
9%
Hypertension
9%
Dry mouth
9%
Cough
9%
Dehydration
9%
Non-cardiac chest pain
9%
Alanine aminotransferase increased
9%
Anxiety
9%
Blood bilirubin increased
9%
Back pain
4%
White blood cell decreased
4%
Head injury
4%
Hyperglycemia
4%
Hypokalemia
4%
Hyponatremia
4%
Depression
4%
Esophageal ulcer
4%
Flu like symptoms
4%
Bruising
4%
Leukocytosis
4%
Skin tear
4%
Oral petechia
4%
Hypotension
4%
Tremor
4%
Diarrhea
4%
Itchy eyes
4%
Postnasal drip
4%
Edema limbs
4%
Upper respiratory infection
4%
Hoarseness
4%
Hot flashes
4%
Hyperkalemia
4%
Neutrophil count decreased
4%
Peripheral sensory neuropathy
4%
Lung infection
4%
Bloating
4%
Unknown infection
4%
Hematuria
4%
Ascites
4%
Sinus pain
4%
Sore throat
4%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B

Trial Design

4Treatment groups
Experimental Treatment
Group I: Treatment Sequence CDBExperimental Treatment3 Interventions
Participants will receive Treatment C in Treatment Period 1, followed by Treatment D in Treatment Period 2, followed by Treatment B in Treatment Period 3. From Period 2 onwards and during Extension and Long-term Extension Phases, all participants will continue to receive treatment with niraparib and AAP or AAP alone.
Group II: Treatment Sequence CBDExperimental Treatment3 Interventions
Participants will receive single doses of niraparib and AA using niraparib Formulation 3 as Treatment C in Treatment Period 1, followed by Treatment B in Treatment Period 2, followed by Treatment D in Treatment Period 3. From Period 2 onwards and during Extension and Long-term Extension Phases, all participants will continue to receive treatment with niraparib and AAP or AAP alone.
Group III: Treatment Sequence ADBExperimental Treatment3 Interventions
Participants will receive Treatment A in Treatment Period 1 followed by Treatment D in Treatment Period 2, followed by Treatment B in Treatment Period 3. From Period 2 onwards and during Extension and Long-term Extension Phases, all participants will continue to receive treatment with niraparib and AAP or AAP alone.
Group IV: Treatment Sequence ABDExperimental Treatment3 Interventions
Participants will receive single doses of niraparib and abiraterone acetate (AA) using niraparib Formulation 1 as Treatment A in Treatment Period 1, followed by multiple doses of niraparib and AA using niraparib Formulation 2 as Treatment B in Treatment Period 2, followed by multiple doses of niraparib and AA using niraparib Formulation 4 as Treatment D in Treatment Period 3. From Period 2 onwards and during Extension and Long-term Extension Phases, all participants will continue to receive treatment with niraparib and AA-prednisone (AAP) or AAP alone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
2014
Completed Phase 4
~2500
Niraparib
2018
Completed Phase 4
~2400

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
987 Previous Clinical Trials
6,385,523 Total Patients Enrolled
8 Trials studying Prostate Cancer
2,178 Patients Enrolled for Prostate Cancer
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
753 Previous Clinical Trials
3,961,323 Total Patients Enrolled
7 Trials studying Prostate Cancer
2,688 Patients Enrolled for Prostate Cancer

Media Library

Abiraterone Acetate (AA) (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04577833 — Phase 1
Prostate Cancer Research Study Groups: Treatment Sequence ABD, Treatment Sequence ADB, Treatment Sequence CBD, Treatment Sequence CDB
Prostate Cancer Clinical Trial 2023: Abiraterone Acetate (AA) Highlights & Side Effects. Trial Name: NCT04577833 — Phase 1
Abiraterone Acetate (AA) (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04577833 — Phase 1
~28 spots leftby Sep 2025
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