Multicenter Study of Seliciclib (R-roscovitine) for Cushing Disease

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT03774446
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cushing Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Seliciclib — DRUG
    Drug: Seliciclib

Study Details

This phase 2 multicenter, open-label clinical trial will evaluate safety and efficacy of 4 weeks of oral seliciclib in patients with newly diagnosed, persistent, or recurrent Cushing disease. Funding Source - FDA Office of Orphan Products Development (OOPD)

Key Dates

Start date
Nov 2, 2018
Status verified
Sep 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
13 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Seliciclib
    80 mg each day oral seliciclib for 4 weeks

Primary Outcome Measure

Number of participants with a normalized 24-hour urinary free cortisol (UFC) at study completion [ Time Frame: 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Daniel Gomez
[email protected]
424-315-2362
Shlomo Melmed, MD (PRINCIPAL_INVESTIGATOR)
Ning-Ai Liu, MD (SUB_INVESTIGATOR)

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