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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
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

Full criteria on ClinicalTrials.gov

Sites (50)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
OLV Ziekenhuis Aalst
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AalstBelgiumUnknown status
ZNA Middelheim
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AntwerpBelgiumUnknown status
ULB Hôpital Erasme
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BrusselsBelgiumUnknown status
Universitair Ziekenhuis Gent
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GhentBelgiumUnknown status
AZ Groeninge
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KortrijkBelgiumUnknown status
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
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LiègeBelgiumUnknown status
Southern Alberta Institute of Urology / Prostate Cancer Centre
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CalgaryCanadaUnknown status
Centre de Recherche du CHUM
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MontrealCanadaUnknown status
Princess Margaret Cancer Centre - University Health Network
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TorontoCanadaUnknown status
British Columbia Cancer Agency
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VancouverCanadaUnknown status
Hospital Vall d'Hebron
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BarcelonaSpainUnknown status
Hosp. de La Santa Creu I Sant Pau
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BarcelonaSpainUnknown status
Hosp. Univ. de La Princesa
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MadridSpainUnknown status
Hosp Univ Hm Sanchinarro
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MadridSpainUnknown status
Hosp Univ Fund Jimenez Diaz
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MadridSpainUnknown status
Hosp Virgen de La Victoria
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MálagaSpainUnknown status
Royal United Hospital
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BathUnited KingdomUnknown status
University College London Hospitals
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LondonUnited KingdomUnknown status
Southampton General Hospital
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SouthamptonUnited KingdomUnknown status
The Royal Marsden NHS Trust Sutton
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SuttonUnited KingdomUnknown status
Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
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TruroUnited KingdomUnknown status
Soroka Hospital
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BeershebaIsraelUnknown status
Asaf Harofe Medical Center
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Beer YaakovIsraelUnknown status
Rambam Medical Center
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HaifaIsraelUnknown status
Rabin Medical Center
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Petah TikvaIsraelUnknown status
Sheba Medical Center, Tel Hashomer
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Ramat GanIsraelUnknown status
Azienda Ospedaliera Universitaria Careggi di Firenze
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FlorenceItalyUnknown status
Azienda Ospedaliera ''Vito Fazzi''
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LecceItalyUnknown status
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyUnknown status
IRCCS-Fondazione Pascale
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NaplesItalyUnknown status
UOC Oncologia Ospedale Provinciale di Macerata
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Province of MacerataItalyUnknown status
New York Oncology Hematology
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AlbanyUnited StatesUnknown status
MUSC Hollings Cancer Center
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CharlestonUnited StatesUnknown status
The Urology Center of Colorado
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DenverUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center 1
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HarrisonUnited StatesUnknown status
Houston Metro Urology
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HoustonUnited StatesUnknown status
The University of Texas MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
Mayo Clinic - Division Of Hematology/oncology
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JacksonvilleUnited StatesUnknown status
First Urology, PSC
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JeffersonvilleUnited StatesUnknown status
University of Wisconsin Carbone Cancer Center
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MadisonUnited StatesUnknown status
Carolina Urologic Research Center
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Myrtle BeachUnited StatesUnknown status
Urology Associates
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NashvilleUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
Thomas Jefferson University
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PhiladelphiaUnited StatesUnknown status
University of Pittsburgh Medical Center (UPMC)
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PittsburghUnited StatesUnknown status
Utah Cancer Specialists
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Salt Lake CityUnited StatesUnknown status
Chesapeake Urology Research Associates
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TowsonUnited StatesUnknown status
Michigan Institute of Urology
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TroyUnited StatesUnknown status
Urological Associates of Southern Arizona, P.C.
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TucsonUnited StatesUnknown status
Urology of Virginia, PLCC
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Virginia BeachUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.