Fimepinostat, combination HDAC and Pi3-kinase inhibitor tumor-directed therapy for Cushing Disease
Fimepinostat, combination HDAC and Pi3-kinase inhibitor tumor-directed therapy for Cushing Disease
ClinicalTrials.gov ID: NCT05971758
Sponsor: University of California, Los Angeles
Information provided by: Anthony P. Heaney, University of California, Los Angeles (Responsible Party)
Last Update Posted: 2023-08-02
Brief 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.
Official Title:
Fimepinostat, Combination HDAC and Pi3-kinase Inhibitor Tumor-Directed Therapy for Cushing Disease
Intervention / Treatment:
- Drug: Fimepinostat
| Category | Value |
|---|---|
| Study Start (Estimated) |
2024-01-01
|
| Primary Completion (Estimated) |
2025-01-01
|
| Study Completion (Estimated) |
2025-01-01
|
| Enrollment (Estimated) | 20 |
| Study Type | Interventional |
| Phase | Phase 2 |
| Other Study ID Numbers |
FD-07548-01-A1
|