Patologia: Melanoma, Neoplasie del polmone, Neoplasie dello stomaco, Sarcomi dei tessuti molli e gist, Tumori del colon retto, Tumori della testa e del collo, Altre neoplasie
Osservazionale-Sperimentale: Osservazionale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: No
Fase di studio: Non applicabile
Linee di trattamento: Non applicabile
Criteri di inclusione:
- Adult and pediatric (from 1 month to 18-year-old) patients
- Patients with locally advanced or metastatic solid tumor harboring an NTRK gene fusion. NTRK (NTRK1, NTRK2, and NTRK3) gene fusions will be identified locally. Acceptable methods of detection of NTRK gene fusion include NGS, fluorescence in situ hybridization (FISH), reverse-transcription polymerase chain reaction (rt-PCR) or any other genomic testing able to detect NTRK gene fusion. If a pan-TRK IHC method is used, this result needs to be accompanied with the results using one of the other methods noted above.
- Life expectancy of at least 3 months based on clinical judgement
- Decision to treat with larotrectinib made by the treating physician prior to study enrollment
- Patients can also be enrolled if the initial visit (larotrectinib start date) occurred within 2 months ±3 days prior to informed consent signed date
- Signed informed consent form
- For patients under legal age, signed assent by the patient (where applicable) and parental/legal guardian signed informed consent is required.
Criteri di esclusione:
- Any contraindications as listed in the local approved product information
- Pregnancy
- Participation in an investigational program with interventions outside of routine clinical practice
- Prior treatment with larotrectinib or other kinase inhibitor with TRK inhibition
- Patients with NTRK gene amplification or NTRK point mutation.
Trattamento sperimentale:
Larotrectinib
Trattamento di controllo:
NA
Obiettivi primari dello studio:
- Number of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 30 days after last dose ]
- Severity of TEAEs [ Time Frame: Up to 30 days after last dose ]
- Seriousness of TEAEs [ Time Frame: Up to 30 days after last dose ]
- Outcome of TEAEs [ Time Frame: Up to 30 days after last dose ]
- Causality of TEAEs [ Time Frame: Up to 30 days after last dose ]
- Action taken related to larotrectinib treatment [ Time Frame: Up to 30 days after last dose ]
Istituto Ortopedico Rizzoli
Via Pupilli 1 - 40136 Bologna - BO
IRCCS A.O.U. San Martino - IST
Largo Rosanna Benzi 10 - 16132 Genova - GE
Riferimento: Prof. Alberto Sobrero
Email: alberto.sobrero@hsanmartino.it
Grande Ospedale Metropolitano Niguarda
Piazza Ospedale Maggiore 3 - 20162 Milano - MI
Riferimento: Dr. Elio Gregory Pizzutilo
Telefono: 0264442291
Email: eliogregory.pizzutilo@ospedaleniguarda.it
Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD
Riferimento: Dr.ssa Sara Lonardi
Telefono: 0498215953
Email: sara.lonardi@iov.veneto.it
Centro di Riferimento Oncologico
Via Franco Gallini 2 - 33081 Aviano - PN
Riferimento: Dr.ssa Vanessa Buoro
Telefono: 0434659421
Email: vanessa.buoro@cro.it
AUSL/IRCCS di Reggio Emilia
Viale Risorgimento 80 - 42123 Reggio nell'Emilia - RE
Riferimento: Dr. Carmine Pinto
Telefono: 0522296614
Email: carmine.pinto@ausl.re.it
A.O.U San Luigi Gonzaga
Regione Gonzole 10 - 10043 Orbassano - TO
Riferimento: Prof.ssa Silvia Novello
Telefono: 0119026978
Email: silvia.novello@unito.it
AOUI Verona - Borgo Roma
Piazzale Ludovico Antonio Scuro 10 - 37134 Verona - VR
AOU Careggi
Largo Brambilla 3 - 50134 Firenze - FI
Riferimento: Prof. Lorenzo Antonuzzo
Telefono: 0557947298
Istituto Nazionale Tumori “Regina Elena”
Via Elio Chianesi 53 - 00144 Roma - RM
Istituto Tumori “Giovanni Paolo II” IRCCS
Viale Orazio Flacco 65 - 70124 Bari - BA
Riferimento: Dr. Michele Guida
Telefono: 0805555136
Email: m.guida@oncologico.bari.it
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA
Riferimento: Dr. Antonio Avallone
Telefono: 0815903629
Email: a.avallone@istitutotumori.na.it
Numero di iscrizione a registro: NCT04142437
Data di inserimento: 08.06.2023
Bayer
Istituto Oncologico Veneto, Padova
Riferimento: Dr.ssa Sara Lonardi
Telefono: 0498215953
Email: sara.lonardi@iov.veneto.it
Localita: Padova