NCT03431350Active, not recruitingPhase 2
A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer
A Phase 1b-2 Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Source: ClinicalTrials.gov · Last updated 28 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 136 (actual)
- First submitted
- 6 Feb 2018
- Start date
- 2 Mar 2018
- Primary completion date
- 31 Aug 2021
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Prostate cancer
- NCT number
- NCT03431350
- EudraCT number
- 2017-003552-23
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 136
- From 2 Mar 2018 to the primary completion date, 31 Aug 2021
- 50 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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:
- 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
Other
- Symptomatic brain metastases
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (50)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| OLV Ziekenhuis Aalst Coordinator of this site? Confirm its status | Aalst | Belgium | Unknown status |
| ZNA Middelheim Coordinator of this site? Confirm its status | Antwerp | Belgium | Unknown status |
| ULB Hôpital Erasme Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| AZ Groeninge Coordinator of this site? Confirm its status | Kortrijk | Belgium | Unknown status |
| Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| Southern Alberta Institute of Urology / Prostate Cancer Centre Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Centre de Recherche du CHUM Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Princess Margaret Cancer Centre - University Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| British Columbia Cancer Agency Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Hospital Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hosp. de La Santa Creu I Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hosp. Univ. de La Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hosp Univ Hm Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hosp Univ Fund Jimenez Diaz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hosp Virgen de La Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Royal United Hospital Coordinator of this site? Confirm its status | Bath | United Kingdom | Unknown status |
| University College London Hospitals Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Southampton General Hospital Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| The Royal Marsden NHS Trust Sutton Coordinator of this site? Confirm its status | Sutton | United Kingdom | Unknown status |
| Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital Coordinator of this site? Confirm its status | Truro | United Kingdom | Unknown status |
| Soroka Hospital Coordinator of this site? Confirm its status | Beersheba | Israel | Unknown status |
| Asaf Harofe Medical Center Coordinator of this site? Confirm its status | Beer Yaakov | Israel | Unknown status |
| Rambam Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Rabin Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Sheba Medical Center, Tel Hashomer Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Azienda Ospedaliera Universitaria Careggi di Firenze Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Azienda Ospedaliera ''Vito Fazzi'' Coordinator of this site? Confirm its status | Lecce | Italy | Unknown status |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| IRCCS-Fondazione Pascale Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| UOC Oncologia Ospedale Provinciale di Macerata Coordinator of this site? Confirm its status | Province of Macerata | Italy | Unknown status |
| New York Oncology Hematology Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| MUSC Hollings Cancer Center Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| The Urology Center of Colorado Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center 1 Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| Houston Metro Urology Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| The University of Texas MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Mayo Clinic - Division Of Hematology/oncology Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| First Urology, PSC Coordinator of this site? Confirm its status | Jeffersonville | United States | Unknown status |
| University of Wisconsin Carbone Cancer Center Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Carolina Urologic Research Center Coordinator of this site? Confirm its status | Myrtle Beach | United States | Unknown status |
| Urology Associates Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of Pittsburgh Medical Center (UPMC) Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Utah Cancer Specialists Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Chesapeake Urology Research Associates Coordinator of this site? Confirm its status | Towson | United States | Unknown status |
| Michigan Institute of Urology Coordinator of this site? Confirm its status | Troy | United States | Unknown status |
| Urological Associates of Southern Arizona, P.C. Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Urology of Virginia, PLCC Coordinator of this site? Confirm its status | Virginia Beach | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.