A Multicenter, Randomized, Open-label, Phase 3 Trial Comparing LOXO-292 to Physicians Choice of Cabozantinib or Vandetanib in Patients with Progressive, Advanced, Kinase Inhibitor Naïve, RET-Mutant Medullary Thyroid Cancer - J2G-MC-JZJB

Studio Clinico

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.

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2019-001978-28

Data di inserimento: 04.08.2020

Data di aggiornamento: 07.04.2023

Promotore

Eli Lilly and Company

CRO

IQVIA

Principal Investigator ITALIA

Azienda Ospedaliero Univesitaria Pisana, Ospedale Cisanello - Pisa

Riferimento: Prof.ssa Rossella Elisei

Telefono: 050995120

Email: rossella.elisei@med.unipi.it

Localita: Pisa