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NCT05971758 · ClinicalTrials.gov registry record · Phase 2

Fimepinostat, Combination HDAC and Pi3-kinase Inhibitor Tumor-Directed Therapy for Cushing Disease

A Phase 2 study of Cushing Disease, sponsored by University of California, Los Angeles.

Recruiting
Registry status
Phase 2
Development phase
20
Enrollment target
1
Study location

NCT05971758: Recruiting Phase 2 study of Cushing Disease, sponsored by University of California, Los Angeles.

NCT05971758 is a Phase 2 study of Cushing Disease that is actively recruiting participants, run by University of California, Los Angeles. The registered enrollment target is 20 participants, below the 390-participant average among 8 other Cushing Disease trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05971758, a Phase 2 study of Cushing Disease, is actively recruiting participants, sponsored by University of California, Los Angeles.

RECRUITING
Registry status
Phase 2
Development phase
20 participants
Enrollment target
1
Study location

Study Summary

Supported by the pre-clinical data (summarized in Research Strategy), the investigators propose that Fimepinostat is an ideal candidate drug in the treatment and intervention of patients with Cushing Disease. The investigators propose a pilot, short-term (4 weeks) phase II single-center study to demonstrate the safety and efficacy of Fimepinostat in the treatment of patients with de novo, persistent, and/or recurrent CD recruited at the University of California, Los Angeles. The trial will have a 2-arm design and will simultaneously examine two different doses of Fimepinostat. The study will allow the investigators to determine the efficacy and safety of these doses in the treatment of CD and guide dose selection for subsequent, larger studies. Funding Source - FDA OOPD.

Primary Outcome

4 week UFC calculated as the mean of three 24h UFC specimens collected on consecutive days between day 24-28

Conditions Studied

Interventions

  • DRUG Fimepinostat

Study Locations (1)

California

  • Ronald Reagan Medical Center - Los Angeles

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2025-01-16
Est. Completion 2029-01
Phase Phase 2

What NCT05971758 shows while recruiting

NCT05971758 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 390-participant average among 8 other Cushing Disease trials with a reported enrollment target (95% lower).

The record links to 1 condition, with Cushing Disease appearing as the primary indexed condition, and to 1 intervention - of which Fimepinostat is the first listed.

NCT05971758 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT05971758 about?

NCT05971758 is a clinical study titled "Fimepinostat, Combination HDAC and Pi3-kinase Inhibitor Tumor-Directed Therapy for Cushing Disease". Supported by the pre-clinical data (summarized in Research Strategy), the investigators propose that Fimepinostat is an ideal candidate drug in the treatment and intervention of patients with Cushing Disease. The investigators propose a pilot, short-term (4 weeks) phase II single-center study to dem...

What is the current status of trial NCT05971758?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2025-01-16. Estimated completion is 2029-01.

What conditions does trial NCT05971758 study?

This clinical trial studies the following conditions: Cushing Disease.

What interventions are being tested in trial NCT05971758?

The interventions under investigation include: Fimepinostat (DRUG).

Who is sponsoring clinical trial NCT05971758?

This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05971758 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Cushing Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05971758's enrollment target sits among peer trials

20 7th of 8 higher than 2 of 8 other Cushing Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cushing Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05971758, the US trial registry maintained by the National Library of Medicine. NCT05971758 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.