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A phase 2 study of Futibatinib in patients with specific FGFR aberrations - TAS-120-202

Studio Clinico

Patologia: Neoplasie della mammella, Tumori dell’utero, Carcinoma della vescica, Neoplasie cerebrali, Tumori della testa e del collo, Neoplasie del polmone, Neoplasie dello stomaco, Tumori dell’esofago, Epatocarcinoma, Tumori del colon retto, Mieloma, Linfomi, Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Known FGFR aberration status and tumor type that meet all of the criteria for 1 of the following cohorts:
    a. Cohort A
i. Histologically-confirmed, locally-advanced, advanced, or metastatic solid tumors harboring a FGFR1-4
ii. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
iii. Had disease progression/recurrence after standard treatment for their cancer
    b. Cohort B
i. Histologically-confirmed, locally-advanced, advanced, or metastatic gastric or gastroesophageal junction cancer harboring a FGFR2 amplification.
ii. Measurable disease per RECIST 1.1
iii. Received at least 2 prior systemic regimens for advanced/metastatic disease
iv. Experienced disease progression/recurrence during or after the most recent prior systemic treatment for advanced/metastatic gastric cancer or GEJ cancer
    c. Cohort C
i. Confirmed myeloid or lymphoid neoplasms as defined by WHO criteria with a FGFR1 rearrangement
ii. Not a candidate for hematological stem cell transplant (HSCT) or relapsed after HSCT and donor lymphocyte infusion, and progressed and not a candidate for other therapies.

Criteri di esclusione: 

- History and/or current evidence of any of the following disorders:
    a. Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the Investigator
    b. Ectopic mineralization/calcification including, but not limited to, soft tissue, kidneys, intestine, or myocardia and lung, considered clinically significant in the opinion of the Investigator
    c. Retinal or corneal disorder confirmed by retinal/corneal examination and considered clinically significant in the opinion of the Investigator.
- Prior treatment with an FGFR inhibitor
- Brain metastases that are untreated or clinically or radiologically unstable (that is, have been stable for <1 month)

Schema di trattamento: 

Futibatinib tablets will be dosed orally every day on a continuous 28-day cycle.

Trattamento sperimentale: 

- Futibatinib (Cohort A)
Advanced or metastatic solid tumors harboring FGFR1-4 rearrangements

- Futibatinib (Cohort B)
Advanced or metastatic solid gastric or GEJ cancer harboring FGFR2 amplification

- Futibatinib (Cohort C)
Myeloid or lymphoid neoplasm harboring FGFR1 rearrangement

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

- Objective response rate (ORR) in Cohorts A and B [ Time Frame: Approximately 6 months ]
    ORR, defined as the proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors, RECIST version 1.1), based on independent central review of radiological images.

- Complete response (CR) rate in Cohort C [ Time Frame: Approximately 6 months ]
    CR rate, defined as the proportion of patients who achieved a CR (per response criteria for MLN) based on investigators' assessment of imaging, peripheral blood, and bone marrow.

Centri partecipanti

Nord Italia

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

 

Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI
Divisione Sviluppo Nuovi Farmaci per Terapie Innovative

Riferimento: Prof. Giuseppe Curigliano
Telefono: 0257489599
Email: giuseppe.curigliano@ieo.it

 

Ospedale Sacro Cuore Don Calabria
Via Via Don A. Sempreboni 5 - 37024 Negrar - VR

Riferimento: Dr.ssa Stefania Gori
Telefono: 0456013550
Email: stefania.gori@sacrocuore.it

 

AOUI Verona - Borgo Roma
Piazzale Ludovico Antonio Scuro 10 - 37134 Verona - VR

Riferimento: Prof. Davide Melisi
Telefono: 0458128148
Email: davide.melisi@univr.it

 

Centro Italia

AOU Careggi
Largo Brambilla 3 - 50134 Firenze - FI

Riferimento: Prof. Alessandro Maria Vannucchi
Telefono: 0557947688
Email: CRIMM@aou-careggi.toscana.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2019-004084-49

Data di inserimento: 18.03.2021

Promotore

Taiho Oncology

CRO

/

Principal Investigator ITALIA

Azienda Ospedaliera Universitaria Integrata Verona - Policlinico G.B. Rossi

Riferimento: Prof. Davide Melisi

Telefono: 0458128148

Email: davide.melisi@univr.it

Localita: Verona

 

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