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NCT01742988 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Safety, Tolerability and Pharmacokinetics of Fimepinostat (CUDC-907) in Patients With Lymphoma
A Phase 1 study, sponsored by Curis.
- Completed
- Registry status
- Phase 1
- Development phase
- 106
- Enrollment target
NCT01742988 is a Phase 1 study that has completed, run by Curis. The registered enrollment target is 106 participants.
The verdict
NCT01742988, a Phase 1 study, has completed, sponsored by Curis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 106 participants
- Enrollment target
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.
Interventions
- DRUG Rituximab
- DRUG venetoclax
- DRUG fimepinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2012-12 |
| Est. Completion | 2020-10-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01742988
The ClinicalTrials.gov registry entry for NCT01742988 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Curis, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Rituximab is the first listed.
NCT01742988 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01742988 about?
NCT01742988 is a clinical study titled "Study to Assess the Safety, Tolerability and Pharmacokinetics of Fimepinostat (CUDC-907) in Patients With Lymphoma". 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...
What is the current status of trial NCT01742988?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 106 participants. The study started on 2012-12. Estimated completion is 2020-10-09.
What interventions are being tested in trial NCT01742988?
The interventions under investigation include: Rituximab (DRUG), venetoclax (DRUG), fimepinostat (DRUG).
Who is sponsoring clinical trial NCT01742988?
This trial is sponsored by Curis, which has 12 total clinical trials registered on ClinicalTrials.gov.
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