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

ConditionCushing Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCedars-Sinai Medical Center

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and female patients at least 18 years old

Persistent hypercortisolemia established by two consecutive 24-hour UFC assessment ≥1.5× the upper limit of normal

Normal or elevated ACTH levels

Pituitary adenoma (>1 cm) on MRI or inferior petrosal sinus sampling (IPSS) central to peripheral ACTH gradient >2 at baseline and >3 after CRH stimulation

Disqualifiers

Patients with compromised visual fields, and not stable for at least 6 months

Patients with abutment or compression of the optic chiasm on MRI and normal visual fields

Patients with Cushing's syndrome due to non-pituitary ACTH secretion

Patients with hypercortisolism secondary to adrenal tumors or nodular (primary) bilateral adrenal hyperplasia

Trial design

Design model

Single group

Treatments tested in this trial

  • Seliciclib

    Drug

    Drug: Seliciclib

Treatment groups

13 Participants
are divided into 1 treatment group
Group A: SeliciclibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with a normalized 24-hour urinary free cortisol (UFC) at study completion

Time frame
4 weeks
2

Number of participants with UFC above the upper limit of normal (ULN) but reduced by ≥50% from baseline at study completion

Time frame
4 weeks

Secondary outcomes

1

Plasma adrenocorticotrophic hormone

Time frame
Baseline and week 4
2

Salivary cortisol

Time frame
Baseline and week 4
3

Serum cortisol

Time frame
Baseline and week 4
4

Glycated hemoglobin (HbA1c)

Time frame
Baseline and week 4

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cedars-Sinai Medical Center

Lead sponsor

Source ClinicalTrials.gov
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