Groupe d'Etude en Oncologie du Quebec

Titre	A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy
Protocole ID	ENGOT en-21 (KRT-232-118)
ClinicalTrials.gov ID	NCT05797831
Type(s) de cancer	Endomètre
Phase	Phase II-III
Type étude	Clinique
Médicament	Navtemadlin
Institution	CHU DE QUEBEC – UNIVERSITE LAVAL HOPITAL DE L'ENFANT-JESUS 1401 18e Rue, Québec, QC, G1J 1Z4
Ville	Québec
Investigateur(trice) principal(e)	Dre Marie Plante
Coordonnateur(trice)	Maryse Gingras 418-525-4444 poste 67322
Statut	Actif en recrutement
Date d'activation	31-05-2024
Critètes d'éligibilité	ECOG 0-1 Histologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT Subjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1 Adequate hematologic, hepatic and renal function (within 14 days)
Critètes d'exclusion	Has any sarcomas or small-cell carcinomas with neuroendocrine differentiation Prior immune therapy, cytokine therapy, or any investigational therapy (within 28 days) Indwelling surgical drains Grade 2 or higher QTc prolongation History of major organ transplant History of bleeding diathesis; major hemorrhage or intracranial hemorrhage (within 24 weeks)

Groupe d'étude en oncologie du Québec