Clinical trial • Phase III • Oncology
NIRAPARIB for Metastatic prostate cancer
Phase III trial of NIRAPARIB for Metastatic prostate cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Metastatic prostate cancer
- Trial Stage
- Phase III
- Drug Modality
- Small molecule|Peptide/protein/enzyme|Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 21-02-2024
- First CTIS Authorization Date
- 03-04-2024
Trial design
Randomised, abiraterone acetate + prednisone (abiraterone acetate - tablet - 250 mg; prednisone 5 mg) with placebo for niraparib versus niraparib in combination with abiraterone acetate and prednisone. (placebo for niraparib is used in control arm.) Phase III trial across 13 sites in Belgium, Czechia, France and others.
- Randomised
- Yes
- Comparator
- Abiraterone acetate + prednisone (Abiraterone acetate - tablet - 250 mg; Prednisone 5 mg) with placebo for niraparib versus Niraparib in combination with Abiraterone acetate and Prednisone. (Placebo for Niraparib is used in control arm.)
- Biomarker Stratified
- True, HRR gene alteration
- Target Sample Size
- 518
- Trial Duration For Participant
- 364
Eligibility
Recruits 518 No vulnerable populations selected; informed consent forms and subject information documents are provided for adult participants (subject information and informed consent form documents are listed in the CTIS documents)..
- Vulnerable Population
- No vulnerable populations selected; informed consent forms and subject information documents are provided for adult participants (subject information and informed consent form documents are listed in the CTIS documents).
Inclusion criteria
- {"criterion_text":"- HRR gene alteration (as identified by the sponsor's required assays)"}
- {"criterion_text":"- Metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI)"}
- {"criterion_text":"- Metastatic prostate cancer in the setting of castrate levels of testosterone less than or equal to (<=) 50 nanogram per deciliter (ng/dL) on a gonadotropin releasing hormone analog (GnRHa) or bilateral orchiectomy"}
- {"criterion_text":"- Able to continue GnRHa during the study if not surgically castrate"}
- {"criterion_text":"- Score of <= 3 on the brief pain inventory-short form (BPI-SF) question number 3 (worst pain in last 24 hours)"}
Exclusion criteria
- {"criterion_text":"- Prior treatment with a poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor"}
- {"criterion_text":"- Systemic therapy (that is, novel second-generation AR-targeted therapy such as enzalutamide, apalutamide, or darolutamide; taxane-based chemotherapy, or more than 4 months of abiraterone acetate plus prednisone [AAP] prior to randomization) in the metastatic castration-resistant prostate cancer (mCRPC) setting; or AAP outside of the mCRPC setting"}
- {"criterion_text":"- Symptomatic brain metastases"}
- {"criterion_text":"- History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)"}
- {"criterion_text":"- Other prior malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) <= 2 years prior to randomization, or malignancy that currently requires active systemic therapy"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Radiographic progression-free survival (rPFS)","definition_or_measurement_approach":""}
Other endpoints
- {"endpoint_text":"- Biomarker evaluations, PRO","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 518
- Recruitment Window Months
- 95
- Consent Approach
- Informed consent is obtained from adult participants; no paediatric assent required. Subject information and informed consent forms are provided and available in multiple country languages as evidenced by the listed CTIS documents (examples include English, French, Spanish, German, Czech, Italian, Portuguese, Polish, Hungarian, Dutch, Swedish).
Geography
- Total Number Of Sites
- 13
- Total Number Of Participants
- 235
Belgium
- Earliest CTIS Part Ii Submission Date
- 08-03-2024
- Latest Decision Or Authorization Date
- 09-04-2024
- Processing Time Days
- 32
- Number Of Sites
- 1
- Number Of Participants
- 12
Sites
- Site Name
- Ziekenhuis Aan De Stroom
- Department Name
- Oncology
- Principal Investigator Name
- Dirk Schrijvers
- Principal Investigator Email
- dirk.schrijvers@zas.be
- Contact Person Name
- Dirk Schrijvers
- Contact Person Email
- dirk.schrijvers@zas.be
Czechia
- Earliest CTIS Part Ii Submission Date
- 08-03-2024
- Latest Decision Or Authorization Date
- 04-04-2024
- Processing Time Days
- 27
- Number Of Sites
- 1
- Number Of Participants
- 11
Sites
- Site Name
- Uromedical Center s.r.o.
- Department Name
- Urology
- Principal Investigator Name
- Vladimir Student
- Principal Investigator Email
- vladimir.student@fnol.cz
- Contact Person Name
- Vladimir Student
- Contact Person Email
- vladimir.student@fnol.cz
France
- Earliest CTIS Part Ii Submission Date
- 08-03-2024
- Latest Decision Or Authorization Date
- 03-04-2024
- Processing Time Days
- 26
- Number Of Sites
- 2
- Number Of Participants
- 37
Sites
- Site Name
- Besancon University Hospital Center
- Department Name
- Oncology department
- Principal Investigator Name
- Tristan MAURINA
- Principal Investigator Email
- t1maurina@chu-besancon.fr
- Contact Person Name
- Tristan MAURINA
- Contact Person Email
- t1maurina@chu-besancon.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Oncology department
- Principal Investigator Name
- Emmanuelle BOMPAS
- Principal Investigator Email
- emmanuelle.bompas@ico.unicancer.fr
- Contact Person Name
- Emmanuelle BOMPAS
- Contact Person Email
- emmanuelle.bompas@ico.unicancer.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 08-03-2024
- Latest Decision Or Authorization Date
- 12-04-2024
- Processing Time Days
- 35
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Universitaetsklinikum Muenster AöR
- Department Name
- Urology
- Principal Investigator Name
- Martin Boegemann
- Principal Investigator Email
- martin.boegemann@ukmuenster.de
- Contact Person Name
- Martin Boegemann
- Contact Person Email
- martin.boegemann@ukmuenster.de
- Site Name
- Otto Von Guericke Universitaet Magdeburg
- Department Name
- Urology
- Principal Investigator Name
- Martin Schostak
- Principal Investigator Email
- martin.schostak@med.ovgu.de
- Contact Person Name
- Martin Schostak
- Contact Person Email
- martin.schostak@med.ovgu.de
Hungary
- Earliest CTIS Part Ii Submission Date
- 08-03-2024
- Latest Decision Or Authorization Date
- 04-04-2024
- Processing Time Days
- 27
- Number Of Sites
- 1
- Number Of Participants
- 17
Sites
- Site Name
- University Of Szeged
- Department Name
- Onkotherápiás Klinika
- Principal Investigator Name
- Judit Oláh
- Principal Investigator Email
- dr.olah.judit@gmail.com
- Contact Person Name
- Judit Oláh
- Contact Person Email
- dr.olah.judit@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 08-03-2024
- Latest Decision Or Authorization Date
- 04-04-2024
- Processing Time Days
- 27
- Number Of Sites
- 3
- Number Of Participants
- 36
Sites
- Site Name
- Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
- Department Name
- UOS Day-Hospital di Oncologia
- Principal Investigator Name
- Giuseppe Tonini
- Principal Investigator Email
- g.tonini@policlinicocampus.it
- Contact Person Name
- Giuseppe Tonini
- Contact Person Email
- g.tonini@policlinicocampus.it
- Site Name
- Istituto Oncologico Veneto
- Department Name
- S.S. Oncologia Urogenitale
- Principal Investigator Name
- Umberto Basso
- Principal Investigator Email
- umberto.basso@iov.veneto.it
- Contact Person Name
- Umberto Basso
- Contact Person Email
- umberto.basso@iov.veneto.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- Oncologia Universitaria 2
- Principal Investigator Name
- Luca Galli
- Principal Investigator Email
- lugal71@yahoo.it
- Contact Person Name
- Luca Galli
- Contact Person Email
- lugal71@yahoo.it
Portugal
- Earliest CTIS Part Ii Submission Date
- 08-03-2024
- Latest Decision Or Authorization Date
- 03-04-2024
- Processing Time Days
- 26
- Number Of Sites
- 1
- Number Of Participants
- 5
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
- Earliest CTIS Part Ii Submission Date
- 08-03-2024
- Latest Decision Or Authorization Date
- 04-04-2024
- Processing Time Days
- 27
- Number Of Sites
- 1
- Number Of Participants
- 45
Sites
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Oncology
- Principal Investigator Name
- Maribel Sáez
- Principal Investigator Email
- msaez.med@gmail.com
- Contact Person Name
- Maribel Sáez
- Contact Person Email
- msaez.med@gmail.com
Sweden
- Earliest CTIS Part Ii Submission Date
- 08-03-2024
- Latest Decision Or Authorization Date
- 04-04-2024
- Processing Time Days
- 27
- Number Of Sites
- 1
- Number Of Participants
- 9
Sites
- Site Name
- Karolinska University Hospital
- Department Name
- Tema Cancer, Onkologiska Kliniken, 171 76, Stockholm, Sweden
- Principal Investigator Name
- Enrique Castellanos
- Principal Investigator Email
- enrique.castellanos@regionstockholm.se
- Contact Person Name
- Enrique Castellanos
- Contact Person Email
- enrique.castellanos@regionstockholm.se
Poland
- Earliest CTIS Part Ii Submission Date
- 08-03-2024
- Latest Decision Or Authorization Date
- 04-04-2024
- Processing Time Days
- 27
- Number Of Sites
- 1
- Number Of Participants
- 54
Sites
- 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
Sponsor
Primary sponsor
- Full Name
- Janssen - Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Contract research organisations
- Name
- Signant Health Global LLC
- Responsibilities
- sponsorDuties code 3
Third parties
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"sponsorDuties code 3","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Niraparib - capsule - 100 mg
- Active Substance
- NIRAPARIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- Authorised
- Starting Dose
- 100 mg
- Dose Levels
- 100 mg (capsule); max daily dose listed 200 mg
- Maximum Dose
- 200 mg/day
- Investigational Product Name
- Niraparib tosylate monohydrate + abiraterone acetate - Film coated tablet - 159.40 mg (eq. 100mg base) + 500mg / 79.90 mg (eq. 50mg base) + 500mg
- Active Substance
- NIRAPARIB, ABIRATERONE ACETATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- Authorised
- Starting Dose
- 50 mg or 100 mg niraparib equivalent (in combination tablet) + 500 mg abiraterone acetate
- Dose Levels
- 50 mg niraparib equivalent; 100 mg niraparib equivalent (combination tablets)
- Maximum Dose
- 1100-1200 mg total product daily (as listed for combination products)
- Investigational Product Name
- Placebo for Niraparib
- Modality
- Other
- Combination Treatment
- Yes
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