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 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 a

Trial Details

NCT ID
NCT05971758
Phase
PHASE2
Sponsor
University of California, Los Angeles
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • Fimepinostat
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368

Key Eligibility Criteria

  • Male and female patients at least 18 years old
  • Patients with confirmed pituitary origin Cushing syndrome defined as 1, 2\& 3 or 4 \& 5 below:
  • Persistent hypercortisolism defined as a mean of 3 consecutive 24h UFC at baseline assessment ≥ 1.3x ULN
  • Normal or elevated plasma ACTH levels

For full eligibility, visit ClinicalTrials.gov.

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