Groupe d'Etude en Oncologie du Quebec

Titre	An Open-Label Multicenter Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Subjects With Advanced Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma
Protocole ID	H3B-6527
ClinicalTrials.gov ID	NCT02834780
Type(s) de cancer	Foie
Phase	Phase I
Stade	Maladie avancée ou métastatique
Médicament	H3B-6527
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 Petr Kavan
Coordonnateur(trice)	Amanda Kasneci 514-340-8222 poste 26394
Statut	Fermé
Critètes d'éligibilité	Participants with hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (ICC). Must have had at least one prior standard-of-care therapy, unless contraindicated. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. Must be willing to undergo a biopsy prior to treatment and on Cycle 2 Day 1 (Part 2 only). Adequate bone marrow and organ function.
Critètes d'exclusion	Uncontrolled significant active infections, except Hepatitis B (HBV) or Hepatitis C (HCV). Known human immunodeficiency virus (HIV) infection. Presence of gastric or esophageal varices requiring active treatment. Previous treatment with selective FGF19-FGFR4 targeted therapy. Females of childbearing potential, or males who have not had a successful vasectomy, who are unable or unwilling to follow adequate contraceptive measures.

Groupe d'étude en oncologie du Québec