A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE)

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Prostatic Neoplasms

Treatments: Drug: Niraparib; Drug: Apalutamide; Drug: Prednisone; Drug: Abiraterone Acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02924766

64091742PCR1001 (Other Identifier)

CR108230

2016-002694-35 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to assess the safety and pharmacokinetics of niraparib when administered in combination with an androgen receptor (AR)-targeted therapy (apalutamide or abiraterone acetate plus prednisone) in adult men with metastatic castration resistant prostate cancer (mCRPC) who may or may not have deoxyribonucleic acid (DNA)-repair anomalies.

Enrollment: 34 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed prostate cancer (mixed histology is acceptable, with the exception of the small cell pure phenotype, which is be excluded
• At least 1 line of prior taxane-based chemotherapy
• At least 1 line of prior androgen receptor (AR) targeted therapy
• Progression of metastatic prostate cancer in the setting of castrate levels of testosterone or history of bilateral orchiectomy at study entry
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of lesser than or equal to [<=]1

Exclusion criteria

• Known brain metastases or history of seizure
• Prior treatment with a poly (adenosine diphosphate [ADP] ribose) polymerase (PARP) inhibitor
• Prior platinum-based chemotherapy for the treatment of prostate cancer
• Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
• Severe or unstable cardiovascular disease or uncontrolled hypertension
• Left ventricular ejection fraction (LVEF) of lesser than [<] 50 percent (%) as determined by multiple uptake gated acquisition (MUGA) or echocardiography during screening

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Niraparib + Apalutamide/[Abiraterone Acetate + Prednisone]

Experimental group

Description:

Participants will receive initial starting dose of Niraparib 200 milligram (mg) once daily in combination either with Apalutamide 240 mg (4\*60 mg) once daily or Abiraterone Acetate 1000 mg (4\*250 mg) plus 10 mg Prednisone (5 mg twice daily) for 28 days of cycle 1. Once a safe dose of niraparib is selected with each Andrgen Receptor (AR)-targeted therapy \[Apalutamide or Abiraterone Acetate plus Prednisone\], then an expansion phase (Part 2) will open to further explore safety and assess antitumor activity.

Treatment:

Drug: Prednisone

Drug: Apalutamide

Drug: Niraparib

Drug: Abiraterone Acetate