CITADEL-204
Research type
Research Study
Full title
A Phase 2, Open-Label, 2-Cohort Study of INCB050465, a PI3Kδ Inhibitor, in Subjects With Relapsed or Refractory Marginal Zone Lymphoma With or Without Prior Exposure to a BTK Inhibitor.
IRAS ID
230182
Contact name
Peter Johnson
Contact email
Sponsor organisation
Incyte Corporation
Eudract number
2017-000970-12
Clinicaltrials.gov Identifier
Duration of Study in the UK
years, months, days
Research summary
Marginal zone lymphomas (MZL) are a group of Non-Hodgkin’s memory B-cell lymphomas.
Ibrutinib is a drug which binds to a protein called Bruton's tyrosine kinase (BTK) which is crucial for the B-cell movement and maturation. Once BTK is inhibited from participating in B-cell signalling pathways, programmed death (apoptosis) of the B-cell starts and movement to protective tumour environments can also be disrupted. However several studies have shown a short survival period after treatment with Ibrutinib, therefore developing treatment options in the post-Ibrutinib setting is warranted. INCB050465 is a potent and selective Phosphoinositide 3-kinase delta inhibitor and has demonstrated success in subjects with relapsed MZL that have not been treated by a BTK inhibitor (naïve). This international study is designed to further evaluate the efficacy and safety of INCB050465 in subjects with MZL that has relapsed.
This study will enrol one group of subjects who have received prior treatment with Ibrutinib and another group will be subjects that are BTK inhibitor-naïve. Upon successful screening all patients will initially receive INCB050465 administered orally at a dose of 20 mg once daily for 8 weeks. After 8 weeks, either 20mg once weekly or 2.5 mg of INCB050465 daily will be administered to the Subjects. Subjects will receive treatment until disease progression, death, unacceptable toxicity, or consent withdrawal. When the subject permanently discontinues study treatment, then the end of treatment (EOT) visit should be conducted. Subjects who discontinue study treatment for a reason other than disease progression will continue to be followed for disease assessments by radiologic imaging.Study assessments include: physical examinations, questionnaires, vital signs, ECG, blood and urine tests, tumour and bone marrow biopsy, CT/MRI scan and optional skin and tool sample collection.
The study will run in 4 UK centres, 49 in Europe and 40 centres in the US will participate.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
17/SC/0454
Date of REC Opinion
13 Oct 2017
REC opinion
Further Information Favourable Opinion