Trial Profile
Phase 2 Study of Bruton's Tyrosine Kinase (Btk) Inhibitor, Ibrutinib (PCI-32765), in Waldenstrom's Macroglobulinemia
Status:
Completed
Phase of Trial:
Phase II
Latest Information Update: 07 Nov 2021
Price :
$35
*
At a glance
- Drugs Ibrutinib (Primary)
- Indications Waldenstrom's macroglobulinaemia
- Focus Registrational; Therapeutic Use
- Acronyms PCYC-1118E study
- 15 Sep 2020 The protocol was amended according to regulatory guidance to require enrollment of additional participants on the assumption that if the response rate for ibrutinib was 50%, the study would have > 80% power to show a lower boundary of the two-sided 95% CI for response rate > 32, as per results published in the Journal of Clinical Oncology
- 15 Sep 2020 Results of long term follow up from Ibrutinib monotherapy published in the Journal of Clinical Oncology
- 26 Oct 2018 Status changed from active, no longer recruiting to completed.