Contrôle des symptômes

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  • 2021-2635

TITRE (EN) A Randomized Control Trial to Compare Doxycycline to Isotretinoin for the Treatment of Acneiform Eruptions in Cancer Patients on Tyrosine Kinase Inhibitors
PROTOCOLE ID 2021-2635
CLINICAL TRIAL.gov ID NCT04864717
TYPE(S) DE CANCER Contrôle des symptômes
PHASE Phase IV
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) Kevin Pehr
COORDONATEUR(RICE)
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • Participant must be ≥18 years of age, able to understand the study procedures, and agrees to participate in the study by providing written informed consent
  • Participant has histologically- or pathologically-confirmed cancer with a known sensitizing EGFR mutation.
  • Participants must have started EGFR-TKI treatment, and subsequently had an acneiform eruption rated moderate or severe per the Leeds scale.
  • Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
  • Participant has a life expectancy of at least 3 months.
  • Premenopausal participants must use highly effective method of contraception. Female participants are neither pregnant nor breastfeeding
CRITÈRES D'EXCLUSION (EN)
  • Absolute contraindications: pregnancy, breastfeeding, drug allergy

  • Relative contraindications:

    • moderate to severe hypercholesterolemia (total cholesterol >7.8 mmol/L)
    • hypertriglyceridemia (TG >2.55 mmol/L)
    • significant hepatic dysfunction (AST > 55IU/L, ALT > 94 IU/L)
    • suicidal ideation, pseudotumor cerebri
    • refractory nausea or vomiting
    • GI pathology that would prevent absorption of oral therapy.