A Study of INCB050465 in Relapsed or Refractory (MCL)
Research type
Research Study
Full title
A Phase 2, Open-Label, Two-Cohort, Multicenter Study of INCB050465, a PI3Kδ Inhibitor, in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITAδEL-205)
IRAS ID
235113
Contact name
Shankara Paneesha
Contact email
Sponsor organisation
Incyte Corporation
Eudract number
2017-003148-19
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
121,474, IND Number
Duration of Study in the UK
4 years, 1 months, 30 days
Research summary
This is a Phase 2, open-label, 2-cohort study designed to find out if INCB050465 (“Study Drug”) is safe and effective in people who have relapsed or refractory Mantle Cell Lymphoma and who were previously treated either with or without a Brutons tyrosine Kinase (BTK) inhibitor.
INCB050465, is called a PI3Kδ Inhibitor. PI3K are a family of enzymes in the body that are part of cell production and growth, which can include cancer cells. The study drug has been developed to slow down this cell activity.
Participants will be allocated to Cohort 1 or Cohort 2: 60 patients in Cohort 1 that have received prior ibrutinib.and 60 patients in Cohort 2 that have not received a prior BTK inhibitor. Cohort 1 and Cohort 2 will have separate designs, conduct, and analyses.
All subjects will receive INCB050465 20mg once daily for 8 weeks followed by either 20mg once weekly or 2.5mg once daily.
Participants could take part in the study for up to two years, although, on average, participants are only expected to be on the study for about 61 weeks. Participants will be expected to make up to 18 visits to their study centre. The study is divided into three separate time periods, a screening phase, a treatment phase, and a follow up phase.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
18/NE/0072
Date of REC Opinion
18 May 2018
REC opinion
Further Information Favourable Opinion