Clinical trial • Phase III • Oncology
NIRAPARIB, ABIRATERONE ACETATE for Metastatic castration-sensitive prostate cancer (mCSPC)|HRR gene-mutated prostate cancer
Phase III trial of NIRAPARIB, ABIRATERONE ACETATE for Metastatic castration-sensitive prostate cancer (mCSPC)|HRR gene-mutated prostate cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Metastatic castration-sensitive prostate cancer (mCSPC)|HRR gene-mutated prostate cancer
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 02-02-2024
- First CTIS Authorization Date
- 28-03-2024
Trial design
Randomised, abiraterone acetate plus prednisone (abiraterone acetate - tablet - 250 mg; prednison acis 5 mg, tabletten) with matching placebo as control (placebo for niraparib/abiraterone and placebo for abiraterone acetate are specified). Phase III trial across 69 sites in Belgium, Bulgaria, Czechia and others.
- Randomised
- Yes
- Comparator
- Abiraterone acetate plus prednisone (Abiraterone acetate - tablet - 250 mg; Prednison acis 5 mg, Tabletten) with matching placebo as control (placebo for Niraparib/Abiraterone and placebo for Abiraterone acetate are specified).
- Biomarker Stratified
- True, biomarker: Homologous recombination repair (HRR) gene alteration (deleterious germline vs somatic)
- Target Sample Size
- 487
Eligibility
Recruits 487 No vulnerable population selected; the trial enrolls adult participants (male). Informed consent is obtained from each participant using the provided subject information and informed consent forms; no assent procedures are applicable..
- Vulnerable Population
- No vulnerable population selected; the trial enrolls adult participants (male). Informed consent is obtained from each participant using the provided subject information and informed consent forms; no assent procedures are applicable.
Inclusion criteria
- {"criterion_text":"- Pathological diagnosis of prostate adenocarcinoma\n- Must have appropriate deleterious homologous recombination repair (HRR) gene alteration\n- Metastatic disease as documented by conventional imaging with computed tomography (CT) or magnetic resonance imaging (MRI) (for soft tissue lesions) or 99mTc bone scan (for bone lesions). Participants with a single bone lesion on Technetium-99m (99mTc) bone scan with no other non-nodal metastatic disease must have confirmation of bone metastasis by CT or MRI. Participants with lymph node-only disease are not eligible\n- Androgen deprivation therapy (either medical or surgical castration) must have been started >=14 days prior to randomization and participants be willing to continue androgen deprivation therapy (ADT) through the treatment phase"}
Exclusion criteria
- {"criterion_text":"- Prior treatment with a poly (adenosine diphosphate-ribose) polymerase (PARP inhibitor)\n- History of adrenal dysfunction\n- Long-term use of systemically administered corticosteroids (greater than [>] 5 milligrams [mg] of prednisone or the equivalent) during the study is not allowed. Short-term use (<=4 weeks, including taper) and locally administered steroids (for example, inhaled, topical, ophthalmic, and intra-articular) are allowed, if clinically indicated\n- History or current diagnosis of myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Radiographic progression-free survival (rPFS)","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 487
- Recruitment Window Months
- 78
- Consent Approach
- Informed consent obtained from each participant using subject information and informed consent forms. Country-specific ICFs are provided (subject information and ICF documents available per Member State). Participants are adults; no assent procedures.
Geography
- Total Number Of Sites
- 69
- Total Number Of Participants
- 211
Belgium
- Latest Decision Or Authorization Date
- 29-03-2024
- Number Of Sites
- 5
- Number Of Participants
- 9
Sites
- Site Name
- Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
- Department Name
- Oncology
- Principal Investigator Name
- Jean-Charles Goeminne
- Principal Investigator Email
- jean-charles.goeminne@uclouvain.be
- Contact Person Name
- Jean-Charles Goeminne
- Contact Person Email
- jean-charles.goeminne@uclouvain.be
- Site Name
- CHC MontLegia
- Department Name
- Oncology
- Principal Investigator Name
- Geoffrey Matus
- Principal Investigator Email
- geoffrey.matus@chc.be
- Contact Person Name
- Geoffrey Matus
- Contact Person Email
- geoffrey.matus@chc.be
- Site Name
- GasthuisZusters Antwerpen
- Department Name
- Oncology
- Principal Investigator Name
- Michiel Strijbos
- Principal Investigator Email
- michiel.strijbos@gza.be
- Contact Person Name
- Michiel Strijbos
- Contact Person Email
- michiel.strijbos@gza.be
- Site Name
- Algemeen Ziekenhuis Delta
- Department Name
- Oncology
- Principal Investigator Name
- Marlies De Bock
- Principal Investigator Email
- marlies.debock@azdelta.be
- Contact Person Name
- Marlies De Bock
- Contact Person Email
- marlies.debock@azdelta.be
- Site Name
- Clinique Saint-Pierre
- Department Name
- Oncology
- Principal Investigator Name
- Nicolas Whenham
- Principal Investigator Email
- Nicolas.WHENHAM@cspo.be
- Contact Person Name
- Nicolas Whenham
- Contact Person Email
- Nicolas.WHENHAM@cspo.be
Bulgaria
- Latest Decision Or Authorization Date
- 15-04-2024
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Complex Oncological Center Plovdiv EOOD
- Department Name
- Department of Medical Oncology and Oncological Diseases in Gastroenterology
- Principal Investigator Name
- Antoaneta Tomova
- Principal Investigator Email
- dr.tomova@gmail.com
- Contact Person Name
- Antoaneta Tomova
- Contact Person Email
- dr.tomova@gmail.com
Czechia
- Latest Decision Or Authorization Date
- 02-04-2024
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- Urologicka klinika
- Principal Investigator Name
- Milos Brodak
- Principal Investigator Email
- milos.brodak@fnhk.cz
- Contact Person Name
- Milos Brodak
- Contact Person Email
- milos.brodak@fnhk.cz
- Site Name
- Krajska nemocnice Liberec a.s.
- Department Name
- Urologie
- Principal Investigator Name
- Vladimir Samal
- Principal Investigator Email
- vladimir.samal@nemlib.cz
- Contact Person Name
- Vladimir Samal
- Contact Person Email
- vladimir.samal@nemlib.cz
Denmark
- Latest Decision Or Authorization Date
- 02-04-2024
- Number Of Sites
- 4
- Number Of Participants
- 10
Sites
- Site Name
- Rigshospitalet
- Department Name
- Department of Oncology
- Principal Investigator Name
- Gedske Daugaard
- Principal Investigator Email
- gedske.daugaard@regionh.dk
- Contact Person Name
- Gedske Daugaard
- Contact Person Email
- gedske.daugaard@regionh.dk
- Site Name
- Næstved Hospital
- Department Name
- Department of Oncology
- Principal Investigator Name
- Anne Juel Christensen
- Principal Investigator Email
- anjc@regionsjaelland.dk
- Contact Person Name
- Anne Juel Christensen
- Contact Person Email
- anjc@regionsjaelland.dk
- Site Name
- Aalborg University Hospital
- Department Name
- Department of Oncology
- Principal Investigator Name
- Mette Moe Kempel
- Principal Investigator Email
- mmk@rn.dk
- Contact Person Name
- Mette Moe Kempel
- Contact Person Email
- mmk@rn.dk
- Site Name
- Sygehus Lillebaelt Vejle Sygehus
- Department Name
- Department of Oncology
- Principal Investigator Name
- Christine Vestergaard Madsen
- Principal Investigator Email
- christine.vestergaard.madsen@rsyd.dk
- Contact Person Name
- Christine Vestergaard Madsen
- Contact Person Email
- christine.vestergaard.madsen@rsyd.dk
France
- Latest Decision Or Authorization Date
- 28-03-2024
- Number Of Sites
- 13
- Number Of Participants
- 32
Sites
- Site Name
- Centre Hospitalier Intercommunal De Cornouaille
- Department Name
- Oncologie
- Principal Investigator Name
- Josselin Annic
- Principal Investigator Email
- josselin.annic@ch-cornouaille.fr
- Contact Person Name
- Josselin Annic
- Contact Person Email
- josselin.annic@ch-cornouaille.fr
- Site Name
- Institut Bergonie
- Department Name
- Service Oncologie
- Principal Investigator Name
- Mathilde Cabart
- Principal Investigator Email
- m.cabart@bordeaux.unicancer.fr
- Contact Person Name
- Mathilde Cabart
- Contact Person Email
- m.cabart@bordeaux.unicancer.fr
- Site Name
- Centre Oscar Lambret
- Department Name
- Pôle d'Oncologie Médicale
- Principal Investigator Name
- Aurélien Carnot
- Principal Investigator Email
- a-carnot@o-lambret.fr
- Contact Person Name
- Aurélien Carnot
- Contact Person Email
- a-carnot@o-lambret.fr
- Site Name
- Hospital Foch
- Department Name
- Oncologie Médicale
- Principal Investigator Name
- Raffaele Ratta
- Principal Investigator Email
- r.ratta@hopital-foch.com
- Contact Person Name
- Raffaele Ratta
- Contact Person Email
- r.ratta@hopital-foch.com
- Site Name
- Unite De Recherche Clinique HIA Begin
- Department Name
- Oncologie médicale
- Principal Investigator Name
- Hugo Picchi
- Principal Investigator Email
- picchi.hugo90@gmail.com
- Contact Person Name
- Hugo Picchi
- Contact Person Email
- picchi.hugo90@gmail.com
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Pôle régional de cancérologie
- Principal Investigator Name
- Nicolas Whenham
- Principal Investigator Email
- Nicolas.WHENHAM@cspo.be
- Contact Person Name
- Nicolas Whenham
- Contact Person Email
- Nicolas.WHENHAM@cspo.be
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- Service d'Oncologie Médicale
- Principal Investigator Name
- Sylvain Ladoire
- Principal Investigator Email
- SLadoire@cgfl.fr
- Contact Person Name
- Sylvain Ladoire
- Contact Person Email
- SLadoire@cgfl.fr
- Site Name
- Groupe Hospitalier Saint Vincent
- Department Name
- Service d'oncologie Libérale
- Principal Investigator Name
- Louis-Marie Dourthe
- Principal Investigator Email
- lm.dourthe@solcrr.org
- Contact Person Name
- Louis-Marie Dourthe
- Contact Person Email
- lm.dourthe@solcrr.org
- Site Name
- Centre Leon Berard
- Department Name
- Oncologie Médicale
- Principal Investigator Name
- Aude Flechon
- Principal Investigator Email
- aude.flechon@lyon.unicancer.fr
- Contact Person Name
- Aude Flechon
- Contact Person Email
- aude.flechon@lyon.unicancer.fr
- Site Name
- Institut Regional Du Cancer De Montpellier
- Department Name
- Oncologie Médicale
- Principal Investigator Name
- Diego Tosi
- Principal Investigator Email
- diego.tosi@icm.unicancer.fr
- Contact Person Name
- Diego Tosi
- Contact Person Email
- diego.tosi@icm.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- Pôle de Cancérologie
- Principal Investigator Name
- Pierre Cornillon
- Principal Investigator Email
- pierre.cornillon@chu-st-etienne.fr
- Contact Person Name
- Pierre Cornillon
- Contact Person Email
- pierre.cornillon@chu-st-etienne.fr
- Site Name
- Institut Sainte Catherine
- Department Name
- Oncologie
- Principal Investigator Name
- Rania Boustany
- Principal Investigator Email
- r.boustany@isc84.org
- Contact Person Name
- Rania Boustany
- Contact Person Email
- r.boustany@isc84.org
- Site Name
- Besancon University Hospital Center
- Department Name
- Service Oncologie Médicale
- Principal Investigator Name
- Tristan Maurina
- Principal Investigator Email
- t1maurina@chu-besancon.fr
- Contact Person Name
- Tristan Maurina
- Contact Person Email
- t1maurina@chu-besancon.fr
Germany
- Latest Decision Or Authorization Date
- 03-04-2024
- Number Of Sites
- 4
- Number Of Participants
- 12
Sites
- Site Name
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
- Department Name
- Klinik und Poliklinik für Urologie
- Principal Investigator Name
- Christian Thomas
- Principal Investigator Email
- christian.thomas.study@uniklinikum-dresden.de
- Contact Person Name
- Christian Thomas
- Contact Person Email
- christian.thomas.study@uniklinikum-dresden.de
- Site Name
- Staedtisches Klinikum Braunschweig gGmbH
- Department Name
- Klinik fuer Urologie und Uroonkologie, Salzdahlumer Str. 90, 38126 Braunschweig
- Principal Investigator Name
- Peter Hammerer
- Principal Investigator Email
- p.hammerer@klinikum-braunschweig.de
- Contact Person Name
- Peter Hammerer
- Contact Person Email
- p.hammerer@klinikum-braunschweig.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Klinik für Urologie und Uro-Onkologie
- Principal Investigator Name
- Axel Heidenreich
- Principal Investigator Email
- axel.heidenreich@uk-koeln.de
- Contact Person Name
- Axel Heidenreich
- Contact Person Email
- axel.heidenreich@uk-koeln.de
- Site Name
- Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
- Department Name
- not applicable
- Principal Investigator Name
- Tilman Todenhoefer
- Principal Investigator Email
- todenhoefer@studienurologie.de
- Contact Person Name
- Tilman Todenhoefer
- Contact Person Email
- todenhoefer@studienurologie.de
Hungary
- Latest Decision Or Authorization Date
- 02-04-2024
- Number Of Sites
- 4
- Number Of Participants
- 7
Sites
- Site Name
- Komarom-Esztergom Varmegyei Szent Borbala Korhaz
- Department Name
- Onkologiai Osztaly
- Principal Investigator Name
- Andrea Uhlyarik
- Principal Investigator Email
- andrea@uhlyarik.net
- Contact Person Name
- Andrea Uhlyarik
- Contact Person Email
- andrea@uhlyarik.net
- Site Name
- University Of Szeged
- Department Name
- Onkoterapias Klinika
- Principal Investigator Name
- Judit Olah
- Principal Investigator Email
- dr.olah.judit@gmail.com
- Contact Person Name
- Judit Olah
- Contact Person Email
- dr.olah.judit@gmail.com
- Site Name
- Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
- Department Name
- Klinikai Onkologiai es Sugarterapias Centrum
- Principal Investigator Name
- Gergely Dombovari
- Principal Investigator Email
- dombovaridr@freemail.hu
- Contact Person Name
- Gergely Dombovari
- Contact Person Email
- dombovaridr@freemail.hu
- Site Name
- University Of Debrecen
- Department Name
- Onkologiai Klinika
- Principal Investigator Name
- Árkosy Péter
- Principal Investigator Email
- arkosy.peter@med.unideb.hu
- Contact Person Name
- Árkosy Péter
- Contact Person Email
- arkosy.peter@med.unideb.hu
Italy
- Latest Decision Or Authorization Date
- 03-04-2024
- Number Of Sites
- 14
- Number Of Participants
- 56
Sites
- Site Name
- Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Alessandra Mosca
- Principal Investigator Email
- alessandra.mosca@ircc.it
- Contact Person Name
- Alessandra Mosca
- Contact Person Email
- alessandra.mosca@ircc.it
- Site Name
- Azienda Sanitaria Locale Napoli 2 Nord
- Department Name
- Oncologia
- Principal Investigator Name
- Gaetano Facchini
- Principal Investigator Email
- gaetano.facchini@aslnapoli2nord.it
- Contact Person Name
- Gaetano Facchini
- Contact Person Email
- gaetano.facchini@aslnapoli2nord.it
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- Oncologia Medica Uro-Ginecologica
- Principal Investigator Name
- Sandro Pignata
- Principal Investigator Email
- s.pignata@istitutotumori.na.it
- Contact Person Name
- Sandro Pignata
- Contact Person Email
- s.pignata@istitutotumori.na.it
- Site Name
- Azienda USL Toscana Sud Est
- Department Name
- UO Oncologia Medica
- Principal Investigator Name
- Alketa Hamzaj
- Principal Investigator Email
- alketa.hamzaj@uslsudest.toscana.it
- Contact Person Name
- Alketa Hamzaj
- Contact Person Email
- alketa.hamzaj@uslsudest.toscana.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- Oncologia Uro-ginecologica
- Principal Investigator Name
- Nicole Brighi
- Principal Investigator Email
- nicole.brighi@irst.emr.it
- Contact Person Name
- Nicole Brighi
- Contact Person Email
- nicole.brighi@irst.emr.it
- Site Name
- Azienda Socio Sanitaria Territoriale Di Cremona
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Bruno Perrucci
- Principal Investigator Email
- bruno.perrucci@asst-cremona.it
- Contact Person Name
- Bruno Perrucci
- Contact Person Email
- bruno.perrucci@asst-cremona.it
- Site Name
- Azienda Unita Locale Socio Sanitaria N 8 Berica
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Francesca La Russa
- Principal Investigator Email
- francesca.larussa@aulss8.veneto.it
- Contact Person Name
- Francesca La Russa
- Contact Person Email
- francesca.larussa@aulss8.veneto.it
- Site Name
- Azienda Provinciale Per I Servizi Sanitari
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Orazio Caffo
- Principal Investigator Email
- orazio.caffo@apss.tn.it
- Contact Person Name
- Orazio Caffo
- Contact Person Email
- orazio.caffo@apss.tn.it
- Site Name
- European Institute Of Oncology S.r.l.
- Department Name
- Urologia
- Principal Investigator Name
- Franco Nole
- Principal Investigator Email
- franconole.studiclinici@ieo.it
- Contact Person Name
- Franco Nole
- Contact Person Email
- franconole.studiclinici@ieo.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Andrea Necchi
- Principal Investigator Email
- necchi.andrea@hsr.it
- Contact Person Name
- Andrea Necchi
- Contact Person Email
- necchi.andrea@hsr.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Oncologia Medica Genito-urinaria
- Principal Investigator Name
- Elena Verzoni
- Principal Investigator Email
- elena.verzoni@istitutotumori.mi.it
- Contact Person Name
- Elena Verzoni
- Contact Person Email
- elena.verzoni@istitutotumori.mi.it
- Site Name
- Istituto Oncologico Veneto
- Department Name
- Oncologia Medica 1
- Principal Investigator Name
- Marco Maruzzo
- Principal Investigator Email
- marco.maruzzo@iov.veneto.it
- Contact Person Name
- Marco Maruzzo
- Contact Person Email
- marco.maruzzo@iov.veneto.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Luca Galli
- Principal Investigator Email
- l.galli@ao-pisa.toscana.it
- Contact Person Name
- Luca Galli
- Contact Person Email
- l.galli@ao-pisa.toscana.it
- Site Name
- Casa Sollievo Della Sofferenza
- Department Name
- Onco-Ematologia
- Principal Investigator Name
- Franco Morelli
- Principal Investigator Email
- f.morelli@operapadrepio.it
- Contact Person Name
- Franco Morelli
- Contact Person Email
- f.morelli@operapadrepio.it
Portugal
- Latest Decision Or Authorization Date
- 01-04-2024
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Champalimaud Clinical Centre
- Department Name
- Oncology
- Principal Investigator Name
- Nuno Vau
- Principal Investigator Email
- nuno.vau@fundacaochampalimaud.pt
- Contact Person Name
- Nuno Vau
- Contact Person Email
- nuno.vau@fundacaochampalimaud.pt
Spain
- Latest Decision Or Authorization Date
- 01-04-2024
- Number Of Sites
- 12
- Number Of Participants
- 39
Sites
- Site Name
- Hospital Universitario Hm Monteprincipe
- Department Name
- Urology
- Principal Investigator Name
- Javier Romero
- Principal Investigator Email
- jromerootero@hotmail.com
- Contact Person Name
- Javier Romero
- Contact Person Email
- jromerootero@hotmail.com
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Urology
- Principal Investigator Name
- Marcos Aller
- Principal Investigator Email
- a67883@gmail.com
- Contact Person Name
- Marcos Aller
- Contact Person Email
- a67883@gmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Urology
- Principal Investigator Name
- Alfredo Rodriguez
- Principal Investigator Email
- arantolin@yahoo.es
- Contact Person Name
- Alfredo Rodriguez
- Contact Person Email
- arantolin@yahoo.es
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncology
- Principal Investigator Name
- Teresa Alonso
- Principal Investigator Email
- talonsogordoa@gmail.com
- Contact Person Name
- Teresa Alonso
- Contact Person Email
- talonsogordoa@gmail.com
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Oncology
- Principal Investigator Name
- Jose Pablo Maroto
- Principal Investigator Email
- jmaroto@santpau.cat
- Contact Person Name
- Jose Pablo Maroto
- Contact Person Email
- jmaroto@santpau.cat
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Oncology
- Principal Investigator Name
- Lucia Oliva
- Principal Investigator Email
- luciaolifer3@gmail.com
- Contact Person Name
- Lucia Oliva
- Contact Person Email
- luciaolifer3@gmail.com
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- Oncology
- Principal Investigator Name
- Patricia Toquero
- Principal Investigator Email
- patricia.toquero@salud.madrid.org
- Contact Person Name
- Patricia Toquero
- Contact Person Email
- patricia.toquero@salud.madrid.org
- Site Name
- Hospital De Jerez De La Frontera
- Department Name
- Urology
- Principal Investigator Name
- Alvaro Juarez
- Principal Investigator Email
- alvaro.juarez01@gmail.com
- Contact Person Name
- Alvaro Juarez
- Contact Person Email
- alvaro.juarez01@gmail.com
- Site Name
- Parc Tauli Hospital Universitari
- Department Name
- Oncology
- Principal Investigator Name
- Enrique Gallardo
- Principal Investigator Email
- egallardo@tauli.cat
- Contact Person Name
- Enrique Gallardo
- Contact Person Email
- egallardo@tauli.cat
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology
- Principal Investigator Name
- Claudia Fina
- Principal Investigator Email
- cfina@iconcologia.net
- Contact Person Name
- Claudia Fina
- Contact Person Email
- cfina@iconcologia.net
- Site Name
- Hospital General Universitario De Castellon
- Department Name
- Urology
- Principal Investigator Name
- Miguel Rodrigo
- Principal Investigator Email
- m-rodrigo@hotmail.com
- Contact Person Name
- Miguel Rodrigo
- Contact Person Email
- m-rodrigo@hotmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Urology
- Principal Investigator Name
- Maria Jose Ribal
- Principal Investigator Email
- mjribal@clinic.cat
- Contact Person Name
- Maria Jose Ribal
- Contact Person Email
- mjribal@clinic.cat
Sweden
- Latest Decision Or Authorization Date
- 03-04-2024
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Soedersjukhuset AB
- Department Name
- Onkologiska kliniken
- Principal Investigator Name
- Chunde Li
- Principal Investigator Email
- chunde.li@regionstockholm.se
- Contact Person Name
- Chunde Li
- Contact Person Email
- chunde.li@regionstockholm.se
- Site Name
- Karolinska University Hospital
- Department Name
- Onkologiska kliniken, Tema Cancer
- Principal Investigator Name
- Enrique Castellanos
- Principal Investigator Email
- enrique.castellanos@regionstockholm.se
- Contact Person Name
- Enrique Castellanos
- Contact Person Email
- enrique.castellanos@regionstockholm.se
Netherlands
- Latest Decision Or Authorization Date
- 29-03-2024
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Stichting Elisabeth-Tweesteden Ziekenhuis
- Department Name
- internal medecine
- Principal Investigator Name
- Laurens Beerepoot
- Principal Investigator Email
- l.beerepoot@etz.nl
- Contact Person Name
- Laurens Beerepoot
- Contact Person Email
- l.beerepoot@etz.nl
Poland
- Latest Decision Or Authorization Date
- 28-03-2024
- Number Of Sites
- 6
- Number Of Participants
- 25
Sites
- Site Name
- Polimed Specjalistyczna Przychodnia Lekarska
- Department Name
- Oncology
- Principal Investigator Name
- Krzysztof Tupikowski
- Principal Investigator Email
- przychodnia@polimed.wroclaw.pl
- Contact Person Name
- Krzysztof Tupikowski
- Contact Person Email
- przychodnia@polimed.wroclaw.pl
- Site Name
- Szpitale Pomorskie Sp. z o.o.
- Department Name
- Radiotherapy
- Principal Investigator Name
- Dorota Filarska
- Principal Investigator Email
- dfilarska@szpital-morski.pl
- Contact Person Name
- Dorota Filarska
- Contact Person Email
- dfilarska@szpital-morski.pl
- Site Name
- Szpital Grochowski Im.Dr Med. Rafała Masztaka Sp. z o.o.
- Department Name
- Oncology
- Principal Investigator Name
- Iwona Skoneczna
- Principal Investigator Email
- iskoneczna@grochowski.waw.pl
- Contact Person Name
- Iwona Skoneczna
- Contact Person Email
- iskoneczna@grochowski.waw.pl
- Site Name
- Specjalistyczne Gabinety Sp. z o.o.
- Department Name
- Oncology
- Principal Investigator Name
- Izabela Glanowska
- Principal Investigator Email
- iglanowska@medtrials.pl
- Contact Person Name
- Izabela Glanowska
- Contact Person Email
- iglanowska@medtrials.pl
- Site Name
- In Vivo Sp. z o.o.
- Department Name
- Oncology
- Principal Investigator Name
- Marcin Zaremba
- Principal Investigator Email
- zaremba@interia.pl
- Contact Person Name
- Marcin Zaremba
- Contact Person Email
- zaremba@interia.pl
- Site Name
- Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
- Department Name
- Oncology
- Principal Investigator Name
- Bogdan Zurawski
- Principal Investigator Email
- zurawskib@co.bydgoszcz.pl
- Contact Person Name
- Bogdan Zurawski
- Contact Person Email
- zurawskib@co.bydgoszcz.pl
Sponsor
Primary sponsor
- Full Name
- Janssen - Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Contract research organisations
- Name
- PPD Global Limited
- Responsibilities
- sponsorDuties codes: [6]
- Name
- Yprime LLC
- Responsibilities
- ePRO (sponsorDuties [15], value: ePRO)
- Name
- Bioclinica Inc.
- Responsibilities
- Central Reader (sponsorDuties [15], value: Central Reader)
- Name
- Labcorp Central Laboratory Services LP
- Responsibilities
- sponsorDuties codes: [4]
- Name
- Signant Health Global LLC
- Responsibilities
- sponsorDuties codes: [3]
- Name
- SGS Belgium
- Responsibilities
- sponsorDuties codes: [6]
Third parties
- {"country":"United Kingdom","full_name":"PPD Global Limited","duties_or_roles":"sponsorDuties codes: [6]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"sponsorDuties: [15], value: ePRO","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"sponsorDuties: [15], value: Central Reader","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Belgium","full_name":"SGS Belgium","duties_or_roles":"sponsorDuties codes: [6]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"sponsorDuties codes: [3]","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Niraparib tosylate monohydrate+ abiraterone acetate - Film coated tablet- 159.40 mg (eq. 100mg base)+ 500mg
- Active Substance
- NIRAPARIB, ABIRATERONE ACETATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- prodAuthStatus: 1
- Maximum Dose
- 1200
- Investigational Product Name
- Niraparib tosylate monohydrate + abiraterone acetate - Film coated tablet- 79.90 mg (eq. 50mg base)+ 500mg
- Active Substance
- NIRAPARIB, ABIRATERONE ACETATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- prodAuthStatus: 1
- Maximum Dose
- 1100
- Investigational Product Name
- Niraparib
- Active Substance
- NIRAPARIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- prodAuthStatus: 1
- Maximum Dose
- 200
- Investigational Product Name
- Niraparib - capsule - 100 mg
- Active Substance
- NIRAPARIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- prodAuthStatus: 1
- Maximum Dose
- 200
- Investigational Product Name
- Abiraterone acetate - tablet - 250 mg
- Active Substance
- ABIRATERONE ACETATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- prodAuthStatus: 1
- Maximum Dose
- 1000
- Combination Treatment
- Yes
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