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A Phase 1/2 Study of the TRK Inhibitor Selitrectinib in Adult and Pediatric Subjects With Previously Treated NTRK Fusion Cancers - 20810

Studio Clinico

Patologia: Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: I, II

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

- Ages Eligible for Study: 1 Month and older (Child, Adult, Older Adult).
- Advanced solid tumor for which, in the opinion of the investigator, no other standard therapy offers greater benefit.
- A solid tumor diagnosis in the setting of:
    a) a documented NTRK fusion and a clinical history of relapse following a response to a prior TRK inhibitor
    b) a documented NTRK fusion unresponsive to a prior TRK inhibitor
    c) a documented NTRK fusion and a clinical history of intolerance to a prior TRK inhibitor
NTRK gene fusions will be identified in a CLIA-certified (or equivalently-accredited diagnostic) laboratory. If such a report cannot be provided, other available certifications/accreditations are required and need to be documented. Patients with infantile fibrosarcoma (IFS) or congenital mesoblastic nephroma (CMN) may be enrolled based on an ETV6+ FISH test without identifying NTRK3.
- Performance Status: Eastern Cooperative Oncology Group (ECOG) score ≤ 2 in adults or Karnofsky Performance Score (KPS) Score≥50% (age ≥ 16 years) or Lansky Performance Score (LPS) ≥ 40% (age < 16 years).
- Life expectancy of at least 3 months.
- Adequate hematologic, hepatic and renal function.
- Patients with stable central nervous system (CNS) primary tumor, brain metastases, or treated spinal cord compression are eligible if neurological symptoms have been stable for 7 days prior to the first dose of selitrectinib.
- Ability to receive study drug orally or by enteral administration.

Criteri di esclusione: 

- Prior exposure to second generation TRK inhibitor (e.g. selitrectinib, repotrectinib (TPX-0005), taletrectinib (DS-6501b/AB-106)). Exception is in case patient presented intolerance to the second generation TRK inhibitor agent and the duration of exposure was less than 28 days. No previous treatment with selitrectinib is allowed.
- Concurrent treatment with a strong CYP3A4 inhibitor or inducer, consumption of grapefruit juice or Seville oranges, or drugs associated with QT prolongation.
- Clinically significant active cardiovascular disease or history of myocardial infarction within 3 months prior to planned start of selitrectinib, or prolongation of QT interval corrected for heart rate (QTc interval) >480 milliseconds within past 6 months
- Major surgery within 7 days of enrollment
- Uncontrolled systemic bacterial, fungal or viral infection.
- Pregnancy or lactation.
- Known hypersensitivity to selitrectinib or Ora-Sweet® SF and OraPlus® for patients receiving liquid formulation.

Trattamento sperimentale: 

Selitrectinib (BAY2731954)

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

The trial will be conducted in 2 parts: dose escalation and expansion (Phase 1) and Phase 2.

The primary objective of Phase 1 is to establish the recommended dose of selitrectinib to treat neurotrophic tyrosine kinase (NTRK) fusion cancers in patients a) aged 12 years and older and b) younger than 12 years. Secondary objectives of Phase 1 are to characterize the pharmakokinetic properties of the test drug, its safety and tolerability, and to assess the objective response rate (ORR) of NTRK-tumors.

The primary objective of Phase 2 is to assess the overall response rate in NTRK fusion cancer patients as determined by an independent radiology committee (IRR). Secondary objectives of Phase 2 comprise the safety and efficacy of selitrectinib at the recommended dose.

Centri partecipanti

Nord Italia

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

Riferimento: Dr.ssa Michela Casanova
Telefono: 0223902588
Email: michela.casanova@istitutotumori.mi.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2017-004246-20

Data di inserimento: 21.04.2021

Promotore

Bayer

CRO

/

Principal Investigator ITALIA

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Riferimento: Dr.ssa Michela Casanova

Telefono: 0223902588

Email: michela.casanova@istitutotumori.mi.it

Localita: Milano

 

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