Colorectal

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  • MOUNTAINEER-03

TITRE (EN) An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ Metastatic Colorectal Cancer
PROTOCOLE ID MOUNTAINEER-03
CLINICAL TRIAL.gov ID NCT05253651
TYPE(S) DE CANCER Colorectal
PHASE Phase III
TYPE D'ÉTUDE Clinique
INSTITUTION HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS
3755 rue de la Côte Ste. Catherine
(514) 340-8222
VILLE Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E) Petr Kavan
COORDONATEUR(RICE) Oleg Lapsin
514-340-8222 poste 28437
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ

 
CRITÈRES D'EXCLUSION (EN)

  • Prior systemic anticancer therapy for colorectal cancer (CRC) in the metastatic setting

    • May have received chemotherapy for CRC in the adjuvant setting if it was completed >6 months prior to enrollment
  • Radiation therapy within 14 days prior to enrollment (or within 7 days in the setting of stereotactic radiosurgery)
  • Previous treatment with anti-HER2 therapy
  • Ongoing Grade 3 or higher neuropathy
  • GI perforation within 12 months of enrollment