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NCT Number: NCT04577833

A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer

The purpose of this study is to determine the relative bioavailability (rBA; Period 1) and bioequivalence (BE; Period 2 and 3) of various strengths and formulations of niraparib and abiraterone acetate (AA) at steady state under modified fasted conditions in participants with metastatic castration-resistant prostate cancer (mCRPC).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Universitair Ziekenhuis Gent, Ghent, Belgium

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About this study

Niraparib is an orally available, highly selective poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, with potent activity against PARP-1 and PARP-2 deoxyribonucleic acid (DNA)-repair polymerases. AA is a pro-drug of abiraterone which selectively inhibits the enzyme 17 alpha-hydroxylase/C17,20-lyase (CYP17), that is found in the testes and adrenals (leading to systemic inhibition of testosterone production), as well as in prostate tissues and tumors. The rationale of the study is to investigate the various strengths and formulations of niraparib and AA plus prednisone or prednisolone (P) in metastatic castration resistant prostate cancer (mCRPC) participants with and without homologous recombination repair (HRR) gene alterations. In participants with metastatic prostate cancer, DNA-repair anomalies are found in approximately 15 percent (%) to 20% of tumors. This study consists 4 periods: screening phase (up to 21 days); treatment phase (up to 22 days); extension and long-term extension phases (from day 23 until discontinuation); and post-treatment follow up phase (end of treatment [EoT] visit within 30 days after the last dose of study treatment). Total duration of study is up to 1.4 years. Efficacy, safety, pharmacokinetics (PK), and biomarkers will be assessed at specified time points during this study. Participants safety will be monitored throughout the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Diagnosed with metastatic castration-resistant prostate cancer (mCRPC), who in the opinion of the investigator may benefit from treatment in this study
  • 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
  • Willing to provide a tumor sample (archival) for determination of homologous recombination repair (HRR) gene alteration status

Exclusion criteria

  • Symptomatic brain metastases
  • Prior disease progression during treatment with abiraterone acetate (AA) alone or when combined with a poly adenosine diphosphate (ADP)-ribose polymerase inhibitor (PARPi). Prior discontinuation of treatment with AA or PARPi due to AA- or PARPi related toxicity.
  • History or current diagnosis of myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML)
  • Known allergies, hypersensitivity, or intolerance to niraparib or AA or the corresponding excipients of niraparib/AA
  • Any medical condition that would make prednisone/prednisolone use contraindicated

Treatment and study plan

Niraparib

Drug

Niraparib will be administered orally.

Abiraterone Acetate (AA)

Drug

Abiraterone Acetate will be administered orally.

Prednisone

Drug

Prednisone will be administered orally.

Primary outcomes

  1. Maximum Observed Analyte Concentration at Steady State (Cmax,ss) of Niraparib and Abiraterone Acetate (AA) [Period 2 and Period 3]

    Time frame: Predose, up to 10 hour post dose

    Cmax,ss is defined as maximum observed analyte concentration at steady state.

  2. 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)

    Time frame: Predose, up to 24 hours post dose

    AUC (0-24h),ss is defined as area under the plasma concentration-time curve from time zero to 24 hours at steady state.

  3. Ratio of Individual Cmax,ss Values Between Test and Reference Treatment (Period 2 and Period 3)

    Time frame: Predose, up to 10 hours post dose

    Ratio of individual Cmax,ss values between test and reference treatment will be assessed.

  4. Ratio of individual AUC (0-24h),ss Values Between Test and Reference Treatment (Period 2 and Period 3)

    Time frame: Predose, up to 24 hours post dose

    Ratio of individual AUC (0-24h),ss values between test and reference treatment will be assessed.

Secondary outcomes

  1. Maximum Observed Analyte Concentration at (Cmax) of Niraparib and AA (Period 1)

    Time frame: Predose, up to 72 hours post dose

    Cmax is defined as maximum observed analyte concentration.

  2. Area Under the Plasma Concentration-time Curve from Time Zero to 72 Hours (AUC [0-72h]) of Niraparib and AA (Period 1)

    Time frame: Predose, up to 72 hours post dose

    AUC (0-72h) is defined as area under the plasma concentration-time curve from time zero to 72 hours post dosing.

  3. Ratio of individual AUC (0-72h) Values Between Test and Reference Treatment (Period 1)

    Time frame: Predose, up to 72 hours post dose

    Ratio of individual AUC (0-72h) values between test and reference treatment will be assessed.

  4. Serum Testosterone Level

    Time frame: Predose on Day -7, Day 11, Day 12 and Day 23

    Serum testosterone level will be assessed.

  5. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

    Time frame: From study start until study completion (up to 3.1 years)

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

  6. Number of Participants with AEs by Severity

    Time frame: From study start until study completion (up to 3.1 years)

    Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death.

  7. Number of Participants with Clinical Laboratory Abnormalities

    Time frame: From study start until study completion (up to 3.1 years)

    Number of participants with clinical laboratory abnormalities including hematology, serum chemistry and urinalysis will be reported.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

An Open-label, Randomized Study to Assess the Relative Bioavailability (BA) and Bioequivalence (BE) of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer

Important dates

Study start
2020
Primary completion
2021
Study completion
2026
First posted
Oct 8, 2020
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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