A Phase 1b-2 Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Condition: Prostatic Neoplasms, Castration-Resistant

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03431350

Sponsor: Janssen Research & Development, LLC

Phase: Phase 1/Phase 2


  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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

View trial on ClinicalTrials.gov

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