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A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Trial Status: closed to accrual
The purpose of this study is to: a) establish the recommended phase 2 dose (RP2D) and to
evaluate the antitumor activity and safety of niraparib combination therapies
(Combinations 1 and 2) and b) to determine the relative bioavailability of niraparib and
abiraterone acetate (AA) in combination (Combination 3) in participants with metastatic
castration-resistant prostate cancer (mCRPC).
Inclusion Criteria
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03431350.
Locations matching your search criteria
United States
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available
This multicenter study will evaluate safety and efficacy of niraparib in combination with
other anti-cancer agents. Combination 1 will combine niraparib with the anti-programmed
cell death protein (PD)-1 monoclonal antibody cetrelimab, in participants with mCRPC.
Combination 1 has 2 parts: in Part 1 (dose selection), participants will be enrolled to
establish RP2D doses of niraparib and cetrelimab; and Part 2 (dose expansion) will
evaluate the combination therapy in an expanded number of participants into 2 cohorts
(biomarker positive or biomarker negative). Combination 2 will combine niraparib with
abiraterone acetate plus prednisone (AA-P) in mCRPC participants with DNA-repair gene
defects (DRD). Combination 3 will evaluate the relative bioavailability (BA) of niraparib
and AA in combination. In a pharmacokinetics (PK) assessment phase, niraparib and AA will
be administered, and in an extension phase, niraparib and AA-P will be administered.
Combinations 1 and 2 will have 5 phases: A Pre-screening Phase, a Screening Phase, a
Treatment Phase, a Follow-up Phase, and a Long-term Extension (LTE) Phase; Combination 3
has 3 phases: A Screening Phase, A PK Assessment Phase, an Extension Phase (including LTE
phase). Study evaluations will include efficacy, PK, PK/pharmacodynamics, biomarkers,
