Study to Assess the Safety, Tolerability and Pharmacokinetics of Fimepinostat (CUDC-907) in Patients With Lymphoma
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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
- Enrollment
- 106 participants
Conditions and interventions
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)
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
- Dec 2012 (Type not available)
- Primary completion
- Oct 9, 2020 (Actual)
- Completion
- Oct 9, 2020 (Actual)
- Last update posted
- May 6, 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 6, 2021 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01742988 live on ClinicalTrials.gov.