Groupe d'Etude en Oncologie du Quebec

Titre	Phase 1b Multi-indication Study of Anetumab Ravtansine (BAY94-9343) in Patients With Mesothelin Expressing Advanced or Recurrent Malignancies
Protocole ID	15834
ClinicalTrials.gov ID	NCT03102320
Type(s) de cancer	Tumeurs solides
Phase	Phase I
Stade	Maladie avancée ou métastatique
Type étude	Traitement
Médicament	Anetumab Ravtansine (BAY94-9343)
Institution	CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS 3755 rue de la Côte Ste. Catherine, Montréal, QC, H3T 1E2
Ville	Montréal
Investigateur(trice) principal(e)	Dr Gerald Batist
Coordonnateur(trice)	Claudia Schanz 514-340-8222 poste 23651
Statut	Fermé
Critètes d'éligibilité	Availability of tumor tissue for mesothelin expression testing Histologically-confirmed, mesothelin-expressing metastatic or advanced non-metastatic disease (tumour type specific inclusion criteria) At least one measurable lesion according to either Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or International Thymic Malignancy Interest Group (ITMIG) modified RECIST 1.1 as applicable Adequate bone marrow, liver, renal and coagulation function Left ventricular ejection fraction (LVEF) ≥ 50% of the lower limit of normal (LLN) according to local institutional ranges Eastern Cooperative Oncology Group (ECOG) 0 or 1
Critètes d'exclusion	More than one prior anti-tubulin/microtubule agent Corneal epitheliopathy or any eye disorder that may predispose the patients to this condition Symptomatic Central nervous system (CNS) metastases and/or carcinomatous meningitis Contraindication to both CT and MRI contrast agents Active hepatitis B or C infection Pregnant or breast-feeding patients Tumor type specific exclusion criteria

Groupe d'étude en oncologie du Québec