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A randomized, open label, multicenter, Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinumcontaining chemotherapy (FORT-1) - 17403

Studio Clinico

Patologia: Carcinoma della vescica

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico


Fase di studio: II, III

Richiesta mandatoria di tessuto: 

Linee di trattamento: Prima linea, Seconda linea, Terza/N linea

Criteri di inclusione: 

- Existence of archival or fresh biopsy for FGFR testing
- FGFR testing of patients will be performed at the investigators’ discretion up to a max. of 90 days prior to start of screening.
Investigators should ensure all patients will be eligible in terms of disease status and lines of treatment within this timeframe.
- Male or female patients ≥ 18 years of age
- Documented urothelial carcinoma (transitional cell carcinoma) including urinary bladder, renal pelvis, ureters, urethra meeting all of the following criteria
    -  Histologically or cytologically confirmed
        - Patients with mixed histologies are required to have a dominant transitional cell pattern.
    - Locally advanced (T4b, any N; or any T, N 2−3) or metastatic disease (any T, any N and M1).
      Locally advanced bladder cancer must be unresectable i.e. invading the pelvic or abdominal wall (stage T4b) or presenting
with bulky nodal disease (N2-3).
- ECOG Performance Status of 0 or 1
- Disease progression during or following treatment with at least one platinum-containing regimen (patients should have been treated for at least 2 cycles). In patients who received prior adjuvant/neoadjuvant platinum-containing chemotherapy, progression had to occur within 12 months of treatment.
- High FGFR1 or 3 mRNA expression levels (RNAscope score of 3+ or 4+; measurement is part of this protocol) in archival or fresh tumor biopsy specimen
- At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) in contrast enhanced (unless contraindicated) CT or MRI

Criteri di esclusione: 

- Previous or concurrent cancer except
    - cervical carcinoma in situ
    - treated basal-cell or squamous cell skin carcinoma
    - any cancer curatively treated > 3 years before randomization
    - Curatively treated incidental prostate cancer (T1/T2a)
- Ongoing or previous anti-cancer treatment within 4 weeks before randomization.
- More than two prior lines of systemic anti-cancer therapy for urothelial carcinoma
- Ongoing or previous treatment with anti-FGFR directed therapies (e.g. receptor tyrosine kinase inhibitors including rogaratinib or FGFRspecific antibodies) or with taxanes or vinflunine
- Unresolved toxicity higher than National Cancer Institute’s Common Terminology Criteria for Adverse Events, version 4.03 (CTCAE v.4.03) Grade 1 attributed to any prior therapy/procedure excluding alopecia, anemia and/or hypothyroidism
- History or current condition of an uncontrolled cardiovascular disease including any of the following conditions:
    - Congestive heart failure (CHF) NYHA > Class 2
    - Unstable angina (symptoms of angina at rest) or new-onset angina (within last 3 months before randomization)
    - Myocardial infarction (MI) within past 6 months before randomization
    - Unstable cardiac arrhythmias requiring anti-arrhythmic therapy.
     Patients with arrhythmia under control with anti-arrhythmic therapy such as beta-blockers or digoxin are eligible.
- Arterial or venous thrombotic events or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before randomization
- Current evidence of endocrine alteration of calcium phosphate homeostasis (e.g. parathyroid disorder, history of parathyroidectomy, tumor lysis, tumoral calcinosis, paraneoplastic hypercalcemia)
- Any hemorrhage / bleeding event ≥ CTCAE v.4.03 Grade 3 within 4 weeks before randomization
- Current diagnosis of any retinal detachment, retinal pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion

Trattamento sperimentale: 


Trattamento di controllo: 


Obiettivi primari dello studio: 

To demonstrate the superiority of rogaratinib over chemotherapy in terms of prolonging overall survival of urothelial carcinoma patients with FGFR positive tumors.

Obiettivi secondari dello studio: 

- To evaluate additional efficacy including the following variables:
    - progression-free survival (PFS)
    - objective response rate (ORR)
    - disease control rate (DCR)
    - duration of response (DOR)
- To evaluate the safety of rogaratinib (adverse events)

Data di inizio dell'arruolamento: 25.06.2018

Periodo previsto di arruolamento: 40 mesi

Centri partecipanti

Nord Italia

Via P. Maroncelli 40 - 47014 Meldola - FC


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

Riferimento: Dr. Andrea Necchi
Telefono: 0223902402


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


Ospedale Niguarda Ca' Granda
Piazza dell'Ospedale Maggiore 3 - 20162 Milano - MI


A.O.U. Policlinico di Modena
Via del Pozzo 71 - 41100 Modena - MO


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


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


Centro Italia

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


Azienda Ospedaliera San Camillo Forlanini
Via Portuense 332 - 00149 Roma - RM


Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM


Università Campus Bio-medico
Via Álvaro del Portillo 200 - 00128 Roma - RM


Sud Italia e isole

Istituto Tumori “Giovanni Paolo II” IRCCS
Viale Orazio Flacco 65 - 70124 Bari - BA

Informazioni Generali


Numero di iscrizione a registro: 2016-004340-11

Data di inserimento: 08.10.2018





Principal Investigator ITALIA

Riferimento: Dr. Andrea Necchi

Telefono: 0223902402


Localita: Milano


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