A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Official record

Identifier

NCT03431350

Recruiting locations

countries

United StatesBelgiumCanadaIsraelItalySpainUnited Kingdom

Interventions studied

Niraparib 200 mgCetrelimab 240 mgCetrelimab 480 mgAbiraterone acetate 1000 mgPrednisone 5 mg

Lead sponsor

Janssen Research & Development, LLC

Target enrolment

136 participants

Study type

INTERVENTIONAL

Phase

Phase 2

Status

Active, not recruiting

First posted

Feb 13, 2018

Last updated on the registry

Sep 28, 2026

Age

18 Years

Sex

MALE

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria for Combination 3:

* Diagnosed with mCRPC, who in the opinion of the investigator may benefit from treatment in Combination 3 of this study
* Able to continue gonadotropin releasing hormone analogue (GnRHa) therapy during the study if not surgically castrate (that is, subjects who has not undergone bilateral orchiectomy).
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of less than or equal to (\<=) 1
* Toxicity associated with prior chemotherapy or radiotherapy has resolved to Grade \<= 1 (except alopecia or Grade \<= 2 neuropathy) at screening
* Participant must agree not to donate sperm while on study treatment, and for 3 months following the last dose of study treatment

Exclusion Criteria:

* History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
* Active malignancies (that is, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. The only allowed exceptions are: non-muscle invasive bladder cancer; skin cancer (non-melanoma or melanoma); breast cancer; malignancy that is considered cured with minimal risk of recurrence
* Active infection requiring systemic therapy
* Allergies, hypersensitivity, or intolerance to niraparib or the corresponding excipients

Combination 3:

* Symptomatic brain metastases
* Prior disease progression during combination treatment with AA and poly (adenosine diphosphate \[ADP\]-ribose) polymerase inhibitor (PARPi). Prior discontinuation of treatment with AA or PARPi due to AA- or PARPi-related toxicity

Indexed under

Prostate Cancer