Groupe d'Etude en Oncologie du Quebec

Titre	A Phase 2-3, Multicenter, Randomized, Double-blind Study of Selinexor (KPT-330) Versus Placebo in Patients With Advanced Unresectable Dedifferentiated Liposarcoma (DDLS)
Protocole ID	KCP-330-020
ClinicalTrials.gov ID	NCT02606461
Type(s) de cancer	Sarcome
Phase	Phase II-III
Type étude	Traitement
Médicament	Selinexor (KPT-330)
Institution	CENTRE UNIVERSITAIRE DE SANTE MCGILL SITE GLEN 1001 boul. Décarie , Montréal, QC, H4A 3J1
Ville	Montréal
Investigateur(trice) principal(e)	Dr Thierry Alcindor
Coordonnateur(trice)	Caroline Buote 514-934-1934 poste 26215
Statut	Actif en recrutement
Critètes d'éligibilité	Patients ≥12 years of age Body surface area (BSA) ≥ 1.2 m2 Histologic evidence of DDLS at any time prior to randomization AND current evidence of DDLS requiring treatment Must have measurable disease per RECIST v1.1 Response Criteria Radiologic evidence of disease progression within 6 months prior to randomization. If the patient received other intervening therapy after documented disease progression, further disease progression must be documented after the completion of the intervening therapy Must have had at least two (2) prior lines of systemic therapy for liposarcoma (not to exceed 5 prior lines) If patient received any previous systemic therapy, the last dose must have been ≥ 21 days prior to randomization (or ≥ 5 half-lives of that drug - whichever is shorter) with all clinically significant therapy- related toxicities having resolved to less than or equal to Grade 1
Critètes d'exclusion	Patients with pure WDLS, myxoid/round cell or pleomorphic tumor histologic subtypes. Known active Hepatitis B (HepB), Hepatitis C (HepC) or human immunodeficiency virus (HIV) infection. Known central nervous system metastases

Groupe d'étude en oncologie du Québec