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