A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer

  • STATUS
    Recruiting
  • End date
    Feb 25, 2025
  • participants needed
    1000
  • sponsor
    Janssen Research & Development, LLC
Updated on 15 October 2020
Investigator
The Medical Research Network, LLC
Primary Contact
Macquarie University (1.3 mi away) Contact
+479 other location

Summary

The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP plus placebo.

Description

This study will assess efficacy and safety of niraparib in combination with AAP for the treatment of participants with metastatic castration resistant prostate cancer. 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 and selectively inhibits the enzyme 17 alpha-hydroxylase/C17,20-lyase (CYP17), which is found in the testes and adrenals, as well as in prostate tissues and tumors. In participants with metastatic prostate cancer, DNA-repair anomalies are identified in approximately 15 percent (%) to 20% of tumors. The study will consist of 4 phases: a prescreening phase for biomarker evaluation only, a screening phase, a treatment phase, and a follow up phase. During the prescreening phase participants will be evaluated for homologous recombination repair (HRR) gene alteration status and then will be assigned to one of the 2 cohorts based on their biomarker status. Treatment will be administered daily and is planned to be continuous until disease progression, unacceptable toxicity, death, or the sponsor terminates the study. Efficacy, pharmacokinetics, biomarkers, participants reported outcomes and safety will be assessed. The total duration of study will be approximately 66 months.

Details
Treatment prednisone, Placebo, abiraterone acetate, Niraparib, Niraparib and Abiraterone acetate FDC, New Formulation of Niraparib and Abiraterone Acetate (AA)
Clinical Study IdentifierNCT03748641
SponsorJanssen Research & Development, LLC
Last Modified on15 October 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you male?
Do you have any of these conditions: Castration Resistant Prostatic Cancer or Prostate Cancer or Metastatic Prostate Cancer or Prostate Cancer, Early, Recurrent or Malignant neoplasm of p...?
HRR gene alteration (as identified by the sponsor's required assays) as follows
Cohort 1: positive for HRR gene alteration
Cohort 2: not positive for DRD (that is, HRR gene alteration)
Metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI)
Metastatic prostate cancer in the setting of castrate levels of testosterone less than or equal to (<=) 50 nanogram per deciliter (ng/dL) on a gonadotropin releasing hormone analog (GnRHa) or bilateral orchiectomy
Able to continue GnRHa during the study if not surgically castrate
Score of <= 3 on the brief pain inventory-short form (BPI-SF) question number 3 (worst pain in last 24 hours)

Exclusion Criteria

Prior treatment with a poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor
Systemic therapy (that is, novel second-generation AR-targeted therapy such as enzalutamide, apalutamide, or darolutamide; taxane-based chemotherapy, or more than 4 months of abiraterone acetate plus prednisone [AAP] prior to randomization) in the metastatic castration-resistant prostate cancer (mCRPC) setting; or AAP outside of the mCRPC setting
Symptomatic brain metastases
History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
Other prior malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) <= 2 years prior to randomization, or malignancy that currently requires active systemic therapy
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