Tumeur stromale gastro-intestinale

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TITRE (EN) A Phase 3 Randomized, Open-Label, Multicenter Clinical Study of CGT9486+Sunitinib vs. Sunitinib in Subjects With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors
PROTOCOLE ID Peak
CLINICAL TRIAL.gov ID NCT05208047
TYPE(S) DE CANCER Tumeur stromale gastro-intestinale
PHASE Phase III
TYPE D'ÉTUDE
INSTITUTION HOPITAL MAISONNEUVE-ROSEMONT
5415 boul. de l'Assomption
(514) 252-3400
VILLE Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E) Jonathan Noujaim
COORDONATEUR(RICE) Samara Bloom
samara.bloom.cemtl@ssss.gouv.qc.ca
514-252-3400 poste 6244
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • Histologically confirmed locally advanced, metastatic, and/or unresectable GIST. Molecular pathology report must be available for Part 2; if molecular pathology report is unavailable or inadequate, an archival or fresh tumor tissue sample will be required to evaluate mutational status prior to randomization.
  • Documented disease progression on or intolerance to imatinib

  • Subjects must have received the following treatment:

    • Part 1a: Treatment with ≥1 prior lines of therapy for GIST
    • Part 1b: Treatment with ≥2 prior TKI for GISTs
    • Part 2: Prior treatment with imatinib only
  • Have at least 1 measurable lesion according to mRECIST v1.1
  • ECOG - 0 to 2
  • Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits
CRITÈRES D'EXCLUSION (EN)
  • Known PDGFR driving mutations or known succinate dehydrogenase deficiency
  • Clinically significant cardiac disease
  • Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug
  • Gastrointestinal abnormalities including, but not limited to, significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption
  • Any active bleeding excluding hemorrhoidal or gum bleeding
  • Seropositive for HIV 1 or 2, or positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody.
  • Active, uncontrolled, systemic bacterial, fungal, or viral infections at Screening
  • Received strong CYP3A4 inhibitors or inducers
  • Received sunitinib within 3 weeks (Part 1a, Part 1b)