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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.

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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

FieldValue
Enrollment Target 106 participants
Start Date 2012-12
Est. Completion 2020-10-09
Phase Phase 1

Sponsor

Curis

12 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.