Patologia: Tumori della testa e del collo
Osservazionale-Sperimentale: Sperimentale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: Sì
Fase di studio: III
Linee di trattamento: Prima linea
Criteri di inclusione:
· Histologically confirmed, unresectable, locally advanced and/or metastatic MTC and no prior history of treatment with kinase inhibitors for advanced/metastatic disease. Prior systemic or radiation therapy in the adjuvant setting may be allowed with discussion and approval by the Lilly CRS/CRP.
· Radiographic progressive, measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Eisenhauer et al. 2009) at screening compared with a previous image taken within the prior 14 months as assessed by the BICR.
· A RET gene alteration identified in a tumor, germline DNA or blood sample, as defined in Appendix The RET alteration result should be generated from a laboratory with CLIA, ISO/EIC, CAP, or other similar certification.
· Eastern Cooperative Oncology Group (ECOG) performance status score (Oken et al. 1982) of 0-2.
· Ability to swallow capsules and comply with treatment, laboratory monitoring, and required clinic visits for the duration of study participation
· Patients must have discontinued from previous treatments as shown below and fully recovered.
Criteri di esclusione:
. An additional validated oncogenic driver in MTC if known that could cause resistance to selpercatinib treatment. Examples include, but are not limited to RAS gene mutations and ALK gene fusions.
. Symptomatic central nervous system (CNS) metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression.
. Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months, history of Torsades de pointes, or prolongation of the QTcF >470 milliseconds on more than one electrocardiogram (ECG) during screening. Participants who are intended to receive vandetanib if randomized to the control arm ineligible if QTcF is >450 milliseconds.
. Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing uncontrolled intercurrent illness.
. Active hemorrhage or at significant risk for hemorrhage.
. Other malignancy unless nonmelanoma skin cancer, carcinoma in situ of the cervix or malignancy diagnosed ≥2 years previously and not currently active. Participants with multiple endocrine neoplasia type 2 (MEN2) associated pheochromocytoma may be eligible.
Trattamento sperimentale:
Loxo 292
Trattamento di controllo:
Cabozantinib/Vandetanib
Note generali:
Enrollment on hold, waiting for Interim Analysis results.
IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI
Riferimento: Dr.ssa Laura Locati
Telefono: 0223902150
Email: laura.locati@istitutotumori.mi.it
Istituto Auxologico Italiano - IRCCS Osp. San Luca
Piazzale Brescia 20 - 20149 Milano - MI
Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD
AOU Città della Salute e della Scienza di Torino
Corso Bramante 88 - 10126 Torino - TO
Ospedale Molinette
AOU Pisana - Cisanello
Via Paradisa 2 - 56124 Pisa - PI
U.O. di Endocrinologia 1
Riferimento: Prof.ssa Rossella Elisei
Telefono: 050995120
Email: rossella.elisei@med.unipi.it
Istituto Nazionale Tumori “Regina Elena”
Via Elio Chianesi 53 - 00144 Roma - RM
Università La Sapienza Policlinico Umberto I
Viale del Policlinico 155 - 00161 Roma - RM
Azienda Ospedaliera Universitaria Senese
Viale Bracci 16 - 53100 Siena - SI
Policlinico Le Scotte
Presidio Ospedaliero Garibaldi Nesima
Via Palermo 636 - 95122 Catania - CT
Azienda Ospedaliera Universitaria Federico II
Via Sergio Pansini 5 - 80131 Napoli - NA
Numero di iscrizione a registro: 2019-001978-28
Data di inserimento: 04.08.2020
Data di aggiornamento: 07.04.2023
Eli Lilly and Company
IQVIA
Azienda Ospedaliero Univesitaria Pisana, Ospedale Cisanello - Pisa
Riferimento: Prof.ssa Rossella Elisei
Telefono: 050995120
Email: rossella.elisei@med.unipi.it
Localita: Pisa