Status:
ACTIVE_NOT_RECRUITING
A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Prostatic Neoplasms, Castration-Resistant
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT03431350
Start Date
March 2 2018
End Date
December 31 2025
Last Update
December 23 2025
Active Locations (50)
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1
Urological Associates of Southern Arizona, P.C.
Tucson, Arizona, United States, 85741
2
The Urology Center of Colorado
Denver, Colorado, United States, 80211
3
Mayo Clinic - Division Of Hematology/oncology
Jacksonville, Florida, United States, 32224
4
First Urology, PSC
Jeffersonville, Indiana, United States, 47130