INCB039110 in Combination With Ibrutinib in DLBCL subjects
Research type
Research Study
Full title
An Open-Label Phase 1/2 Study of INCB039110 in Combination With Ibrutinib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
IRAS ID
240913
Contact name
Martin Dyer
Contact email
Sponsor organisation
Incyte Corporation
Eudract number
2017-002773-19
Duration of Study in the UK
1 years, 0 months, 19 days
Research summary
INCB039110 is an investigational drug that is being studied by Incyte Corporation for use in combination with ibrutinib. INCB039110 is a drug that blocks enzymes known as Janus protein tyrosine kinases (JAK) with selectivity for a specific enzyme known as JAK1. “Kinases” are proteins inside cells that help cells live and grow. Ibrutinib is also a “kinase inhibitor”. By blocking the activity of the specific kinase known as “Bruton’s Tyrosine Kinase (or BTK), ibrutinib may also stop cancer cells from growing. The purpose of this research study is to assess how safe and well tolerated the study drug INCB039110 is in combination with ibrutinib, in participant’s who have relapsed or refractory DLBCL. This study will also assess the ways in which these drugs are broken down in the body and eliminated, as well as looking at the effects that the drugs may have on participant’s disease. This is an open-label research study, which means that both the researchers and participants know which treatment is being administered. The study has two phases; Phase 1 is called “dose escalation” and is where the doses of each drug are selected for the second phase of the study. Dose escalation is when a small group of participants are given a certain dose of a drug. Phase 2 is called the ‘expansion’ phase and in this phase the study doctor will find out how well the dose selected in Phase 1 works on participant’s cancer type. This application is for the Phase 2 part only. There is one site in the UK where this study is going to be ran.It is anticipated that participant’s will be in the study for approx. 6 months (1 month screening, 4 months treatment & safety follow up for 30 days).
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
18/EM/0116
Date of REC Opinion
14 Jun 2018
REC opinion
Further Information Favourable Opinion