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THOR 42756493-BLC3001: Studio di fase III su erdafitinib rispetto a vinflunina o docetaxel o pembrolizumab in soggetti con tumore uroteliale avanzato e aberrazioni selezionate del gene FGFR

Studio Clinico

Patologia: Carcinoma della vescica

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Richiesta mandatoria di tessuto: 

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

- Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable
- Metastatic or surgically unresectable urothelial cancer
- Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization
- Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression within 12 months of the last dose are considered to have received systemic therapy in the metastatic setting.
- A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)
- Participants must meet appropriate molecular eligibility criteria
- Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
- Adequate bone marrow, liver, and renal function

Criteri di esclusione: 

- Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization
- Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence.
- Symptomatic central nervous system metastases
- Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment
- Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients
- Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade.
- History of uncontrolled cardiovascular disease
- Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions

Trattamento sperimentale: 

  • Cohort 1 (Arm 1A): Erdafitinib
  • Cohort 2 (Arm 2A): Erdafitinib

Trattamento di controllo: 

  • Cohort 1 (Arm 1B): Vinflunine or Docetaxel
  • Cohort 2 (Arm 2B): Pembrolizumab

Obiettivi primari dello studio: 

  1. Overall Survival (OS) [Time Frame: Date of first randomization to the date of participant's death (approximately up to 3 years)]
    Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.

Obiettivi secondari dello studio: 

  1. Progression-free Survival (PFS) [ Time Frame: Date of randomization to the date of disease progression or relapse from complete response (CR) or death, whichever is reported first (approximately up to 3 years) ]
  2. Overall Response Rate (ORR) [ Time Frame: Approximately up to 3 years ]
  3. Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional
  4. Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl) [ Time Frame: Baseline up to end of treatment (approximately 3 years) ]
  5. Change from Baseline in Patient-Global Impression of Severity (PGIS) Score [ Time Frame: Baseline up to end of treatment (approximately 3 years) ]
  6. Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L [ Time Frame: Baseline up to follow up phase (approximately 3 years) ]
  7. Change from Baseline in the Utility Scale of the EQ-5D-5L [ Time Frame: Baseline up to follow up phase (approximately 3 years) ]
  8. Duration of Response (DOR) [ Time Frame: From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years) ]
  9. Number of Participants with Adverse Events (AEs) as a Measure of Safety [ Time Frame: Approximately up to 3 years ]
  10. Oral Clearance (CL/F) of Erdafitinib [ Time Frame: Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days) ]
    Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib [ Time Frame: Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days) ]

Centri partecipanti

Nord Italia

Azienda Spedali Civili di Brescia
Piazzale Spedali Civili 1 - 25123 Brescia - BS

Riferimento: Dr. Vittorio Ferrari
Telefono: 0303996537
Email: bscivile@numerica.it

 

ASST di Cremona
Viale Concordia 1 - 26100 Cremona - CR

Riferimento: Dr. Rodolfo Passalacqua
Telefono: 0372405242
Email: r.passalacqua@asst-cremona.it

 

IRCCS - IRST
Via P. Maroncelli 40 - 47014 Meldola - FC

Riferimento: Dr. Ugo De Giorgi
Email: ugo.degiorgi@irst.emr.it

 

IRCCS A.O.U. San Martino - IST
Largo Rosanna Benzi 10 - 16132 Genova - GE

Riferimento: Prof. Francesco Boccardo
Telefono: 0105554256
Email: francesco.boccardo@hsanmartino.it

 

IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI

Riferimento: Dr. Andrea Necchi
Telefono: 0223902402
Email: andrea.necchi@istitutotumori.mi.it

 

Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI

Riferimento: Dr. Franco Nolè
Telefono: 0294379234
Email: franco.nole@ieo.it

 

A.O.U. “ Maggiore della Carità”
Corso Mazzini 18 - 28100 Novara - NO

Riferimento: Dr.ssa Alessandra Mosca
Telefono: 03213733984

 

Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD

Riferimento: Dr. Umberto Basso
Telefono: 0498215953
Email: umberto.basso@iov.veneto.it

 

IRCCS Policlinico San Matteo
Viale Golgi 19 - 27100 Pavia - PV

Riferimento: Dr. Camillo Porta
Telefono: 0382501355
Email: c.porta@smatteo.pv.it

 

Centro di Riferimento Oncologico
Via Franco Gallini 2 - 33081 Aviano - PN

Riferimento: Dr.ssa Alessandra Bearz
Telefono: 0434659294
Email: abearz@cro.it

 

A.O.U San Luigi Gonzaga
Regione Gonzole 10 - 10043 Orbassano - TO

Riferimento: Prof. Giorgio Vittorio Scagliotti
Telefono: 0119026414
Email: giorgio.scagliotti@unito.it

 

AOU Città della Salute e della Scienza di Torino
Corso Bramante 88 - 10126 Torino - TO

Riferimento: Dr. Mario Airoldi
Telefono: 0116706029
Email: mario.airoldi@unito.it

 

Centro Italia

Istituto Toscano Tumori Ospedale San Donato
Via Pietro Nenni 20 - 52100 Arezzo - AR

Riferimento: Dr. Sergio Bracarda
Telefono: 0575255439
Email: sergio.bracarda@uslsudest.toscana.it

 

AOU Careggi
Largo Brambilla 3 - 50134 Firenze - FI

 

AOU Pisana - Santa Chiara
Via Roma 67 - 56126 Pisa - PI

Riferimento: Dr. Luca Galli
Telefono: 050992466

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2017-002932-18

Data di inserimento: 09.04.2019

Promotore

Janssen Research & Development, LLC

CRO

/

Principal Investigator ITALIA

Fondazione IRCCS - Istituto Nazionale dei Tumori, Milano

Riferimento: Dr. Andrea Necchi

Telefono: 0223902402

Email: andrea.necchi@istitutotumori.mi.it

Localita: Milano

 

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