Titre A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study
Protocole ID PCI-32765CAN3001
ClinicalTrials.gov ID NCT01804686
Type(s) de cancer Leucémie lymphoïde chronique (LLC)
Phase Phase III
Type étude Traitement
Médicament Ibrutinib
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) Dre Sarit Assouline
Coordonnateur(trice) Sergyi Mukha
 514-340-8222 poste 28437
Statut Fermé
Critètes d'éligibilité
  • Participants must be currently participating in a PCI-32765 clinical study considered completed and have received at least 6 months of treatment with PCI-32765.
  • At study entry, participants must be actively receiving treatment with single-agent PCI-32765 or participants must have participated in a PCI-32765 randomized clinical study in which they initially received comparator treatment and now cross-over to ibrutinib. Note: A minimum of 6 months requirement for prior PCI-32765 treatment will not be mandatory in this case and participants with less than 6 months will be required to have more frequent initial safety assessments
  • Agrees to protocol-defined use of effective contraception
  • Negative blood or urine pregnancy test at screening
Critètes d'exclusion
  • Requires anticoagulation with warfarin or equivalent vitamin K antagonists
  • Requires treatment with strong cytochrome P450 (CYP)3A4/5 inhibitors, unless previously approved by sponsor
  • Any condition or situation which, in the opinion of the investigator, may put the participant at significant risk, may confound the study results, or may interfere significantly with volunteer's participation in the study