CITADEL-202: Safety and Efficacy of INCB050465 in B-Cell Lymphoma
Research type
Research Study
Full title
A Phase 2, Multicenter, International, Open-Label, Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)
IRAS ID
224022
Contact name
Dr Ian Chau
Contact email
Sponsor organisation
Incyte Corporation
Eudract number
2016-002205-19
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Research Summary
This is an open-label, monotherapy (single therapy) study of INCB050465 in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have received 2 to 5 prior therapies. The study consists of 2 groups: Group A and Group B. In Group A, 100 subjects who were not previously treated with a BTK (Bruton's tyrosine kinase) inhibitor (eg, ibrutinib) will be enrolled. In Group B, up to 20 subjects who were previously treated with a BTK inhibitor will be enrolled.The study drug will be administered to subjects orally, 20 mg once daily for 8 weeks followed by 20 mg once weekly, until the subject leaves the study.
Subject participation through safety follow-up is expected to average approximately 11 months, which includes the following:
• A screening period lasting up to 28 days.
• A treatment period lasting as long as the subject is receiving benefit, tolerating the regimen, and has not met withdrawal criteria (approximately 9 months).
• A safety follow-up period lasting 30 to 35 days.Subjects will be followed for approximately 12 months after the safety follow-up period. Subjects withdrawn from study treatment for reasons other than disease progression will be followed for disease assessment until either radiologic disease progression, the start of a new anticancer therapy, or death (whichever occurs first). Subjects withdrawn from study treatment because of disease progression will be followed approximately every 12 weeks for subsequent anticancer therapies and survival.
The target enrolment for this study is 100 to 120 subjects. The study is sponsored by Incyte Corporation.
Summary of Results
The study enrolled 60 participants: 55 participants in Group A (participants who had been previously treated with a Bruton's tyrosine kinase (BTK) inhibitor ) and 5 participants in Group B (participants that had previously received a BTK inhibitor).
The study drug (INCB050465; parsaclisib) showed manageable side effects and had no unexpected safety signals when given as directed in the study.
An early, planned analysis for the first 40 participants in Group A was performed. This analysis showed that tumors became substantially smaller in 10 (25%) of these participants. Based on the statistics set forth in the study plan, the result of 25% was not high enough for the study to enroll the 120, originally-planned participants. Enrollment in both groups was stopped early and the study was completed.REC name
London - Riverside Research Ethics Committee
REC reference
17/LO/0927
Date of REC Opinion
26 Jul 2017
REC opinion
Further Information Favourable Opinion