Study to Assess the Safety, Tolerability and Pharmacokinetics of Fimepinostat (CUDC-907) in Patients With Lymphoma
Status:
Completed
Trial end date:
2020-10-09
Target enrollment:
Participant gender:
Summary
This is a phase 1, open-label, dose-escalation study of fimepinostat (CUDC-907) in patients
with relapsed and/or refractory diffuse large B-cell lymphoma (DLBCL), or high-grade B-cell
lymphoma (HGBL) with or without MYC and BCL2 alterations. Fimepinostat (CUDC-907) is a
multi-targeted agent designed to inhibit phosphoinositide 3-kinase (PI3K)and histone
deacetylase (HDAC). The study is designed to assess the safety, the maximum tolerated dose,
the recommended phase 2 dose (RP2D), pharmacokinetics and the anti-cancer activity of oral
fimepinostat in combination with 1 or more anti-cancer regimens.