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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

No Placebo-Only Group

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.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from study start until study completion (up to 3.1 years)

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%

Abdominal pain

22%

Dizziness

22%

Insomnia

22%

Dyspnea

17%

Headache

17%

Mucositis oral

17%

Platelet count decreased

17%

Creatinine increased

13%

Vomiting

13%

Rash maculo-papular

13%

Aspartate aminotransferase increased

13%

Sinus tachycardia

Cough

Dehydration

Urinary tract infection

Dry mouth

Hypertension

Non-cardiac chest pain

Alanine aminotransferase increased

Anxiety

Blood bilirubin increased

Back pain

Upper respiratory infection

Hoarseness

Hypotension

Hot flashes

Head injury

Hypokalemia

Hyponatremia

Flu like symptoms

Hyperglycemia

Neutrophil count decreased

Tremor

Diarrhea

Depression

Itchy eyes

Oral petechia

Edema limbs

Bruising

Esophageal ulcer

Hyperkalemia

Peripheral sensory neuropathy

Leukocytosis

White blood cell decreased

Postnasal drip

Skin tear

Lung infection

Bloating

Unknown infection

Hematuria

Ascites

Sinus pain

Sore throat

Syncope

100%

80%

60%

40%

20%

Study treatment Arm

Cohort A

Cohort B

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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