Titre A Phase 1b/2, Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotorasib Monotherapy and in Combination With Other Anti-cancer Therapies in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation
Protocole ID 20190135 (CodeBreak 101)
ClinicalTrials.gov ID NCT04185883
Type(s) de cancer Tumeurs solides
Phase Phase I-II
Stade Maladie avancée ou métastatique
Type étude Clinique
Médicament Sotorasib en monothérapie et en association avec d'autres thérapies
Institution    L'HOTEL-DIEU DE QUEBEC ET CRCEO
      11 Côte du Palais, Québec, QC, G1R 2J6
Ville Québec
Investigateur(trice) principal(e) Dr Maxime Chénard-Poirier
Coordonnateur(trice) Maryse Gingras
 418-691-5781
Statut Actif en recrutement
Critètes d'éligibilité
  • Men or women greater than or equal to 18 years old.
  • Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing performed according to in-country requirements. 
Critètes d'exclusion
  • Primary brain tumor.
  • Spinal cord compression, or untreated, or symptomatic, or active brain metastases, or leptomeningeal disease from non-brain tumors.
  • Myocardial infarction within 6 months of study day 1.
  • Gastrointestinal (GI) tract disease causing the inability to take oral medication.