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An Open-Label, Multicenter Phase 2 Basket Study to Evaluate the Antitumor Activity and Safety of Lenvatinib in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Malignancies - MK-7902-013

Studio Clinico

Patologia: Neoplasie cerebrali, Sarcomi dei tessuti molli e gist, Tumori del rene, 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: 

- Has histologically or cytologically documented relapsed, or refractory pediatric solid malignancy excluding osteosarcoma;
- Has measurable disease as defined by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) for High Grade Glioma (HGG);
- Has a performance status defined as follows: 1) Lansky Play Score >=50 for participants up to and including 16 years of age 2) Karnofsky performance status (KPS) >=50 for participants >16 years of age 3) Neurologic deficits in participants with primary central nervous system (CNS) tumors must have benn stable for at least 7 days prior to study enrollment;
- Demonstrate adequate organ function;
- No clinical evidence of nephrotic syndrome;
- Has adequate blood pressure (BP) control with or without antihypertensive medications;
- Has adequate cardiac function;
- Has adequate neurologic function

Criteri di esclusione: 

- Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years
- WOCBP who has a postive urine pregnancy test within 72 hours before the first dose of study treatment
Baseline left ventricular ejection fraction value<50% or shortening fraction of <27%
- Has GI bleeding or active hemoptysis within 21 days prior to enrollment
- Has CNS tumors with a history of symptomatic tumor hemorrhage
- Has evidence of untreated CNS metastases
- Has preexisting >= Grade 3 GI or non GI fistula
- Has any active infection requiring systemic therapy Has clinically significant ECG abnormality, including a marked baseline prolonged QT or QTc interval
- Known to be HIV positive
- Active viral hepatitis (B or C) as demonstrated by positive serology
- Has any active infection requiring systemic therapy

Trattamento sperimentale: 

Lenvatinib

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

Objective Response Rate (ORR) At Week 16 per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for High Grade Glioma [HGG] only), by Investigator Assessment [ Time Frame: Week 16 of treatment ]
    ORR at Week 16 is defined as the percentage of participants with a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters [SOD] of target lesions, taking as reference the baseline SOD) as assessed by the investigator per RECIST 1.1 at 16 Weeks. For participants with HGG, response is assessed according to RANO criteria whereby overall response is based on both radiographic response (CR: disappearance of all target lesions, PR: sum of products of diameters [SPD] decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information.

Centri partecipanti

Nord Italia

Ospedale Infantile Regina Margherita di Torino
Piazza Polonia 94 - 10126 Torino - TO

Riferimento: Prof.ssa Franca Fagioli
Telefono: 0113135230
Email: franca.fagioli@unito.it

 

Centro Italia

Azienda Ospedaliera Universitaria Meyer
Viale Pierracini 24 - 50139 Firenze - FI

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2019-004441-33

Data di inserimento: 16.04.2021

Promotore

Merck Sharp & Dohme Corp.

CRO

NA

Principal Investigator ITALIA

Ospedale Pediatrico Bambino Gesù, Roma

Riferimento: Prof. Franco Locatelli

Telefono: 0668592129

Email: franco.locatelli@opbg.net

Localita: Roma

 

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