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Fimepinostat

DRUG3 trials

Sponsors

Curis, Inc., Sabine Mueller, MD, PhD, University of California, Los Angeles

Conditions

Cushing DiseaseDiffuse Intrinsic Pontine GliomaDouble-expressor Lymphoma (DEL)Double-hit Lymphoma (DHL)High-grade B-cell Lymphoma (HGBL)LymphomaRecurrent Anaplastic AstrocytomaRecurrent Glioblastoma

Early Phase 1

Fimepinostat in Treating Brain Tumors in Children and Young Adults
Active, not recruitingNCT03893487
Sabine Mueller, MD, PhDDiffuse Intrinsic Pontine Glioma, Recurrent Anaplastic Astrocytoma, Recurrent Glioblastoma +2
Start: 2019-08-07End: 2027-08-31Updated: 2025-07-11

Phase 1

Study to Assess the Safety, Tolerability and Pharmacokinetics of Fimepinostat (CUDC-907) in Patients With Lymphoma
CompletedNCT01742988
Curis, Inc.Double-expressor Lymphoma (DEL), Double-hit Lymphoma (DHL), High-grade B-cell Lymphoma (HGBL) +8
Start: 2012-12-31End: 2020-10-09Updated: 2021-05-06

Phase 2

Fimepinostat, Combination HDAC and Pi3-kinase Inhibitor Tumor-Directed Therapy for Cushing Disease
RecruitingNCT05971758
University of California, Los AngelesCushing Disease
Start: 2025-01-16End: 2029-01-01Target: 20Updated: 2026-07-17

Related Papers

Advancements in B-Cell Non-Hodgkin's Lymphoma: From Signaling Pathways to Targeted Therapies.
2024-11-124 citations
Phase Ib trial combining rapid determination of drug-drug interaction (DDI) followed by a dose finding period to assess safety and preliminary efficacy of fimepinostat plus venetoclax in patients with aggressive B-cell lymphoma.
Journal of Clinical Oncology2020-05-20
Correlation of MYC gene signature variations with clinical response to fimepinostat in patients with aggressive B-cell lymphoma.
Journal of Clinical Oncology2020-05-20
A Multi-Center Dose-Finding Study to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Fimepinostat (CUDC-907) in Combination with Venetoclax in Patients with Relapsed/Refractory (R/R) Lymphoma
Blood2019-11-13
Phase 2, open-label study of CUDC-907 with and without rituximab in patients with relapsed/refractory MYC-altered diffuse large B-cell lymphoma.
Journal of Clinical Oncology2016-05-20
Safety, tolerability, and preliminary activity of CUDC-907, a first-in-class, oral, dual inhibitor of HDAC and PI3K, in patients with relapsed or refractory lymphoma or multiple myeloma: an open-label, dose-escalation, phase 1 trial.
2016-03-31156 citations
Phase 1 first-in-human trial of oral CUDC-907, a dual inhibitor of PI3K and HDAC, in patients with refractory/relapsed lymphoma or multiple myeloma.
Journal of Clinical Oncology2015-05-202 citations