Phase 2 study of INCB050465 in Relapsed or Refractory FL
Research type
Research Study
Full title
A Phase 2, Multicenter, Open-Label Study of INCB050465, a PI3Kδ Inhibitor, in Relapsed or Refractory Follicular Lymphoma (CITADEL-203)
IRAS ID
227801
Contact name
David Cunningham
Contact email
Sponsor organisation
Incyte Corporation
Eudract number
2017-001624-22
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
121,474, IND Number
Duration of Study in the UK
2 years, 8 months, 14 days
Research summary
This is an open label, phase II study of the study drug, INCB050465, in participants with relapsed of refractory (non-responsive to treatment) follicular lymphoma. The study drug, 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.
Approximately 100 adult participants are to be recruited, from sites in the USA, Canada, Australia, Israel and Europe.
Participants will be assigned to one of two treatment groups, on a 1:1 basis (50 participants will be assigned to each group), to receive the following treatment:
Group A - INCB050465 once a day for 8 weeks, then once a week at the same dose;
Group B - INCB050465 once a day for 8 weeks, then once a day at a lower dose.Participants are expected, on average, to take part in the study for about two years. Once participants stop taking the study drug they will be followed to monitor their survival status. 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 West - Liverpool Central Research Ethics Committee
REC reference
18/NW/0171
Date of REC Opinion
12 Apr 2018
REC opinion
Further Information Favourable Opinion