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

• Status: Active, not recruiting
• Trial end date: 2023-01-31
• Target enrollment: 0
• Participant gender: Male

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Abiraterone Acetate; Niraparib; Prednisone

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