Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-24 @ 4:52 PM
NCT ID:
NCT03431350
Eligibility 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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03431350
Study Brief:
Protocol Section:
NCT03431350