Groupe d'Etude en Oncologie du Quebec

Titre	A phase 2, randomized, double-blind, placebo-controlled study to investigate the efficacy, safety and tolerability of ponsegromab in patients with cancer, cachexia, and elevated concentrations of gdf-15, followed by an optional open-label treatment period
Protocole ID	PROACC -1
ClinicalTrials.gov ID	NCT05546476
Type(s) de cancer	Autre
Phase	Phase II
Type étude	Clinique
Médicament	Ponsegromab
Institution	CIUSSS DU SAGUENAY – LAC-SAINT-JEAN HOPITAL DE CHICOUTIMI 305, rue Saint-Vallier G7H 5H6 , Chicoutimi, QC
Ville	Chicoutimi
Investigateur(trice) principal(e)	Dr Marc Trudeau
Coordonnateur(trice)	Alexandra Simard 418-541-1000 poste 3163
Statut	Fermé
Date d'activation	16-08-2023
Critètes d'éligibilité	Documented active diagnosis of non-small cell lung, pancreatic, colorectal cancer Cachexia defined by Fearon criteria of weight loss Serum GDF-15 concentrations Signed informed consent ECOG PS ≤3 with life expectancy of at least 4 months to be able to complete Part A.
Critètes d'exclusion	Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization. Current active reversible causes of decreased food intake. Cachexia caused by other reasons. History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody. Inadequate liver function Renal disease requiring dialysis

Groupe d'étude en oncologie du Québec