Trials / Completed
CompletedNCT01742988
Study to Assess the Safety, Tolerability and Pharmacokinetics of Fimepinostat (CUDC-907) in Patients With Lymphoma
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 106 (actual)
- Sponsor
- Curis, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | fimepinostat | |
| DRUG | Rituximab | |
| DRUG | venetoclax |
Timeline
- Start date
- 2012-12-01
- Primary completion
- 2020-10-09
- Completion
- 2020-10-09
- First posted
- 2012-12-06
- Last updated
- 2021-05-06
Locations
11 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01742988. Inclusion in this directory is not an endorsement.