FIGHT-302: first-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with FGFR2 rearrangements.
Future Oncol
; 16(30): 2385-2399, 2020 10.
Article
en En
| MEDLINE
| ID: mdl-32677452
ABSTRACT
FGFR2 rearrangements resulting in dysregulated signaling are drivers of cholangiocarcinoma (CCA) tumorigenesis, and occur almost exclusively in intrahepatic CCA. Pemigatinib, a selective, potent, oral inhibitor of FGFR1-3, has demonstrated efficacy and safety in a Phase II study of patients with previously treated locally advanced/metastatic CCA harboring FGFR2 fusions/rearrangements. We describe the study design of FIGHT-302, an open-label, randomized, active-controlled, multicenter, global, Phase III study comparing the efficacy and safety of first-line pemigatinib versus gemcitabine plus cisplatin in patients with advanced CCA with FGFR2 rearrangements (NCT03656536). The primary end point is progression-free survival; secondary end points are objective response rate, overall survival, duration of response, disease control rate, safety and quality of life. Clinical Trial Registration NCT03656536 (ClinicalTrials.gov).
Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Pirimidinas
/
Pirroles
/
Neoplasias de los Conductos Biliares
/
Reordenamiento Génico
/
Protocolos de Quimioterapia Combinada Antineoplásica
/
Morfolinas
/
Colangiocarcinoma
/
Receptor Tipo 2 de Factor de Crecimiento de Fibroblastos
Tipo de estudio:
Clinical_trials
/
Diagnostic_studies
/
Guideline
Límite:
Female
/
Humans
/
Male
Idioma:
En
Revista:
Future Oncol
Año:
2020
Tipo del documento:
Article
País de afiliación:
Estados Unidos