Tumeurs solides

TITRE (EN) A phase 1A/B open-label master study of PF-07799544 as a single-agent and in combination with other targeted agents in participants with advanced solid tumors
PROTOCOLE ID C4901001
CLINICAL TRIAL.gov ID NCT05538130
TYPE(S) DE CANCER Tumeurs solides
PHASE Phase I
TYPE D'ÉTUDE Clinique
INSTITUTION CENTRE UNIVERSITAIRE DE SANTE MCGILL
1001 boul. Décarie
VILLE Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E) Ramy Saleh
COORDONATEUR(RICE) Abdul-Rahman El-Hassan
514-934-1934 poste 35161
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • Diagnosis of advanced/metastatic solid tumor including primary brain tumor for monotherapy phase 1a dose escalation
  • Disease progressed during/following last prior treatment and no satisfactory alternative treatment options for monotherapy phase 1a dose escalation
  • For Substudy A and B, histological or cytological diagnosis of advanced/metastatic melanoma
  • For Substudy A and B, measurable disease by RECIST version 1.1
  • For Substudy A, evidence of a BRAF V600 mutation in tumor tissue and/or blood
  • For Substudy B, evidence of a BRAF V600 mutation or BRAF Class II alteration in tumor tissue and/or blood
CRITÈRES D'EXCLUSION (EN)
  • Brain metastasis larger than 4 cm
  • Systemic anti-cancer therapy or small molecule therapeutics ongoing at the start of study treatment.
  • For participants who may get binimetinib on study, history or current evidence of retinal vein occlusion (RVO) or concurrent neuromuscular disorder associated with elevated creatine kinase (CK)