Clinical trial • Phase II • Oncology
Niraparib tosylate monohydrate for Urothelial cancer
Phase II trial of Niraparib tosylate monohydrate for Urothelial cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Urothelial cancer
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 28-11-2024
- First CTIS Authorization Date
- 15-01-2025
Trial design
Randomised, niraparib (zejula 100 mg hard capsules; active substance: niraparib tosylate monohydrate; product information lists max daily dose 300 mg) versus best supportive care (no active anticancer drug). dosing schedule not specified in the provided records.-controlled Phase II trial across 20 sites in Italy.
- Randomised
- Yes
- Comparator
- Niraparib (Zejula 100 mg hard capsules; active substance: niraparib tosylate monohydrate; product information lists max daily dose 300 mg) versus Best Supportive Care (no active anticancer drug). Dosing schedule not specified in the provided records.
- Target Sample Size
- 77
Eligibility
Recruits 77 No vulnerable population selected (isVulnerablePopulationSelected: false). An informed consent form is listed for the trial (CONSENSO INFORMATO v1 1aprile 2021); no details on assent, consenting parties by age, or languages are provided in the available records..
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected: false). An informed consent form is listed for the trial (CONSENSO INFORMATO v1 1aprile 2021); no details on assent, consenting parties by age, or languages are provided in the available records.
Inclusion criteria
- {"criterion_text":"- Established histological or cytological diagnosis of non-resectable or metastatic locally advanced non-resectable urothelial transitional tumor (transitional cell carcinoma both with pure and mixed histology)"}
- {"criterion_text":"- Measurable disease according to RECIST (v1.1) before starting the first chemotherapy line"}
- {"criterion_text":"- The first chemotherapy line must have been performed with at least 4 cycles and no more than 6 cycles of a regimen containing platinum (cisplatin or carboplatin)"}
- {"criterion_text":"- Absence of disease progression after completion of the first chemotherapy line (complete response, partial response or disease stability according to RECIST criteria v1.1)"}
- {"criterion_text":"- Patients should be enrolled within 28 days of a radiological survey demonstrating disease stability or partial / complete disease response and no more than 42 days after receiving the last dose of chemotherapy"}
- {"criterion_text":"- Availability of a blood sample to determine the state of germline mutations of BRCA genes"}
- {"criterion_text":"- Availability of a sample of tumor tissue in the archive to determine the status of the genes involved in the mechanism of homologous recombination (HRD)"}
- {"criterion_text":"- ECOG performance status 0-1"}
Exclusion criteria
- {"criterion_text":"- Known hypersensitivity to the components of Niraparib"}
- {"criterion_text":"- Note active liver disease"}
- {"criterion_text":"- Previous treatment with a PARP inhibitor agent"}
- {"criterion_text":"- Pre-existing toxicity due to previous therapies of degree> 1 according to NCI CTCAE v4.0; however, alopecia, sensory neuropathy (grade 2 or lower), or other grade 2 or lower toxicities that do not pose a risk to the patient at the trial according PI is accepted"}
- {"criterion_text":"- Known history of bone marrow compression or meningeal carcinosis or evidence of symptomatic brain disease or leptomeningi at screening CT or RMN images. Encephalic metastases treated, stable and asymptomatic are permitted"}
- {"criterion_text":"- The diagnosis of other cancers in the last 2 years prior to randomization; are admitted and therefore exceptions are cutaneous squamous tumor or cutaneously treated skin basaloma, in situ carcinoma of the breast or of the cervix, the low-grade prostatic tumor in active surveillance or the prostate tumor already subjected to prostatectomy"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Progression free survival (PFS)","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Proportion of objective answers","definition_or_measurement_approach":""}
- {"endpoint_text":"- Duration of the answer","definition_or_measurement_approach":""}
- {"endpoint_text":"- Global survival","definition_or_measurement_approach":""}
- {"endpoint_text":"- Proportion of progression-free patients at 6 months from randomization.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Safety and tolerability","definition_or_measurement_approach":""}
- {"endpoint_text":"- Quality of life (patient-reported outcomes)","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 77
- Recruitment Window Months
- 84
- Consent Approach
- Informed consent form available (CONSENSO INFORMATO v1 1aprile 2021). No further details in the provided records about who provides consent by age, assent processes, or languages offered.
Geography
- Total Number Of Sites
- 20
- Total Number Of Participants
- 77
Italy
- Earliest CTIS Part Ii Submission Date
- 02-12-2024
- Latest Decision Or Authorization Date
- 15-01-2025
- Processing Time Days
- 44
- Number Of Sites
- 20
- Number Of Participants
- 77
Sites
- Site Name
- AUSL di Reggio Emilia IRCCS, Arcispedale Santa Maria Nuova di Reggio Emilia
- Department Name
- Oncology
- Contact Person Name
- Cristina Masini
- Contact Person Email
- annalisa.berselli@ausl.re.it
- Site Name
- Universita' Campus Bio-medico Di Roma
- Department Name
- Oncology
- Contact Person Name
- Daniele Santini
- Contact Person Email
- t.grassani@unicampus.it
- Site Name
- Azienda Provinciale Per I Servizi Sanitari - Ospedale Civile Santa Chiara
- Department Name
- Oncology
- Contact Person Name
- Orazio Caffo
- Contact Person Email
- trialoffice.oncologia@apss.tn.it
- Site Name
- IRCCS CROB
- Department Name
- Oncology
- Contact Person Name
- MIchele Aieta
- Contact Person Email
- tarta1@virgilio.it
- Site Name
- Istituto Oncologico Veneto
- Department Name
- Oncology
- Contact Person Name
- Umberto Basso
- Contact Person Email
- umberto.basso@iov.veneto.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- Oncology
- Contact Person Name
- Ugo De Giorgi
- Contact Person Email
- emanuela.montanari@irst.emr.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- Oncology
- Contact Person Name
- Luca Galli
- Contact Person Email
- robertalacava89@gmail.com
- Site Name
- Azienda Ospedaliera Ordine Mauriziano Di Torino
- Department Name
- Oncology
- Contact Person Name
- Francesca Vignani
- Contact Person Email
- francesca.vignani@gmail.com
- Site Name
- Azienda Sanitaria Universitaria Friuli Centrale
- Department Name
- Oncology
- Contact Person Name
- Stanislao Cosimo Sacco
- Contact Person Email
- monica.zamparini@asuiud.sanita.fvg.it
- Site Name
- Azienda Unita Sanitaria Locale Di Piacenza
- Department Name
- Oncology
- Contact Person Name
- Luigi Cavanna
- Contact Person Email
- l.cavanna@ausl.pc.it
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- Oncology
- Contact Person Name
- Rosa Tambaro
- Contact Person Email
- r.tambaro@istitutotumori.na.it
- Site Name
- Azienda Ospedaliera Per L'Emergenza Cannizzaro
- Department Name
- Oncology
- Contact Person Name
- Luigi Banna
- Contact Person Email
- gbanna@yahoo.com
- Site Name
- Azienda Ospedaliero-Universitaria Di Cagliari
- Department Name
- Oncology
- Contact Person Name
- Francesco Atzori
- Contact Person Email
- sperimentazioniclinicheunica@gmail.com
- Site Name
- Azienda Ospedaliero Universitaria Careggi
- Department Name
- Oncology
- Contact Person Name
- Laura Doni
- Contact Person Email
- donila@aou-careggi.toscana.it
- Site Name
- Azienda Sanitaria Locale Cn2 Alba-Bra
- Department Name
- Oncology
- Contact Person Name
- Veronica Prati
- Contact Person Email
- veronicaprati@hotmail.com
- Site Name
- Istituto Tumori Bari Giovanni Paolo II
- Department Name
- Oncology
- Contact Person Name
- Emanuele Naglieri
- Contact Person Email
- emanuele.naglieri@gmail.com
- Site Name
- Presidio Ospedaliero Antonio Perrino
- Department Name
- Oncology
- Contact Person Name
- Saverio Cinieri
- Contact Person Email
- laura.orlando68@gmail.com
- Site Name
- Ospedale San Donato
- Department Name
- Oncology
- Contact Person Name
- ALKETA HAMZAJ
- Contact Person Email
- simonetta.magnanini@uslsudest.toscana.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Oncology
- Contact Person Name
- Andrea Necchi
- Contact Person Email
- liana.bevilacqua@istitutotumori.mi.it
- Site Name
- San Camillo Forlanini Hospital
- Department Name
- Oncology
- Contact Person Name
- Fabio Calabrò
- Contact Person Email
- trial.office.sc@gmail.com
Sponsor
Primary sponsor
- Full Name
- Universita' Degli Studi Di Torino
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Italy
Third parties
- {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Group Limited","duties_or_roles":"packaging. secondary labelling and QP release","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Zejula 100 mg hard capsules
- Active Substance
- Niraparib tosylate monohydrate
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (EU MA EU/1/17/1235/001)
- Maximum Dose
- 300 mg
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