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
|