Titre A 6-week, randomized, double-blind, sponsor-open study to assess the effect of repeated subcutaneous administration of pf-06946860 on appetite in participants with advanced cancer and anorexia, followed by an 18-week open-label treatment period
Protocole ID C3651010
ClinicalTrials.gov ID NCT04803305
Type(s) de cancer Contrôle des symptômes
Phase Phase I
Type étude Clinique
Médicament PF-06946860 versus placebo
Institution CISSS DU BAS-SAINT-LAURENT
   HOPITAL REGIONAL DE RIMOUSKI
      150 av. Rouleau, Rimouski, QC, G5L 5T1
Ville Rimouski
Investigateur(trice) principal(e) Dre Marie-Claude Foley
Coordonnateur(trice) Isabelle Gagnon
 418-724-3000 poste 8029
Statut Fermé
Critètes d'éligibilité
  • Documented diagnosis of non-small cell lung, pancreatic, colorectal, prostate, breast or ovarian cancer which, in the treating oncologist's assessment, is considered advanced.
  • Anorexia as defined by a score of ≤5 in the Cancer-Related Cachexia Symptom Assessment Appetite 7-day recall scale
  • Meets any of the following criteria at Randomization:
    • Not currently receiving antineoplastic therapy
    • On standard of care systemic antineoplastic therapy or treatment without curative intent
  • Signed informed consent.
Critètes d'exclusion
  • Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization.
  • Current active reversible causes of decreased food intake.
  • Current, severe gastrointestinal disease
  • Participants with known symptomatic brain metastases requiring steroids.
  • Active uncontrolled bacterial, fungal, or viral infection, including HBV, HCV, HIV or participants with known AIDS-related illness
  • inadequate renal or liver function.
  • Women who are pregnant or breast-feeding