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Study to Assess the Safety, Tolerability and Pharmacokinetics of Fimepinostat (CUDC-907) in Patients With Lymphoma

NCT01742988 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2021-05-06

No results posted yet for this study

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.

Conditions

  • Lymphoma
  • Relapsed Lymphoma
  • Refractory Lymphoma
  • Relapsed and/or Refractory Lymphoma
  • Relapsed Ddiffuse Large B-Cell Lymphoma (DLBCL)
  • Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
  • Relapsed and/or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
  • Double-hit Lymphoma (DHL)
  • Triple-hit Lymphoma (THL)
  • Double-expressor Lymphoma (DEL)
  • High-grade B-cell Lymphoma (HGBL)

Interventions

DRUG

fimepinostat

DRUG

Rituximab

DRUG

venetoclax

Sponsors & Collaborators

  • The Leukemia and Lymphoma Society

    collaborator OTHER

  • Curis, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2020-10-09
Completion
2020-10-09

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01742988 on ClinicalTrials.gov