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

ClinicalTrials.gov ID: NCT01742988

Public ClinicalTrials.gov record NCT01742988. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

Phase 1 Open Label, Multi-center, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered Fimepinostat (CUDC-907), a PI3K and HDAC Inhibitor, in Subjects With Refractory or Relapsed Lymphoma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT01742988
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Curis, Inc.; Industry
Enrollment: 106 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 30, 2012
Primary completion: Oct 8, 2020
Completion: Oct 8, 2020
Last update posted: May 5, 2021

2012 – 2020

United States locations

U.S. sites: 11
U.S. states: 11
U.S. cities: 11

Facility	City	State	ZIP	Site status
USC/Norris Comprehensive Cancer Center	Los Angeles	California	90033	—
Florida Cancer Specialists	Sarasota	Florida	34232	—
Winship Cancer Institute, Emory University	Atlanta	Georgia	30322	—
University of Chicago Medicine	Chicago	Illinois	60637	—
University of Michigan	Ann Arbor	Michigan	48109	—
Memorial Sloan-Kettering Cancer Center	New York	New York	10065	—
Stephenson Cancer Center, University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	73104	—
Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	19104	—
Sarah Cannon Research Institute	Nashville	Tennessee	37203	—
MD Anderson Cancer Center	Houston	Texas	77030	—
Swedish Cancer Institute	Seattle	Washington	98104	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01742988, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 5, 2021 · Synced Sep 4, 2026

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The complete protocol, eligibility criteria, and contact information for NCT01742988 live on ClinicalTrials.gov.

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