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New treatment option for Cushing Disease
Official title Multicenter Study of Seliciclib (R-roscovitine) for Cushing Disease
ClinicalTrials.gov ID: NCT03774446
What this study is testing
What is Seliciclib?
Seliciclib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cushing disease.
Also referred to as R-roscotivine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male and female patients at least 18 years old
- Patients with confirmed pituitary origin of excess adrenocorticotropic hormone (ACTH) production:
- 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...
You likely can't join if
- 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
- Patients who have a known inherited syndrome as the cause for hormone over secretion (i.e., Carney Complex, McCune-Albright syndrome, Multiple...
- Patients with a diagnosis of glucocorticoid-remedial aldosteronism (GRA)
See the full eligibility criteria
Who can join
- Male and female patients at least 18 years old
- Patients with confirmed pituitary origin of excess adrenocorticotropic hormone (ACTH) production:
- 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
- Recurrent or persistent CD defined as pathologically confirmed resected pituitary ACTH-secreting tumor or IPSS central to peripheral ACTH gradient \>2 at baseline and \>3 after CRH stimulation, and 24h-UFC \>ULN beyond...
- Patients on medical treatment for Cushing disease. The following washout periods must be completed before screening assessments are performed:
- Inhibitors of steroidogenesis: metyrapone, ketoconazole: 2 weeks; Levoketoconazole: 3 weeks; osilodrostat: 6 weeks
- Somatostatin receptor ligand pasireotide: short-acting, 2 weeks; long-acting, 4 weeks
- Progesterone receptor antagonist mifepristone: 2 weeks
- Dopamine agonist cabergoline: 4 weeks
- Patients treated with CYP3A or CYP2B6 strong inducers or inhibitors, including those listed below. Required washout time varies between drugs; minimum 5-6 times the half-life of the drug.
- Strong CYP3A inducers: apalutamide, carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John's wort
- Moderate CYP3A inducers: bosentan, efavirenz, etravirine, phenobarbital, primidone
- Weak CYP3A inducers: armodafinil, modafinil, rufinamide
- Strong CYP2B6 inducer: carbamazepine
- Moderate CYP2B6 inducers: efavirenz, rifampin
- Weak CYP2B6 inducers: nevirapine, ritonavir
- Strong CYP3A inhibitors: boceprevir, cobicistat, danoprevir and ritonavir, elvitegravir and ritonavir, grapefruit juice, indinavir and ritonavir, itraconazole, ketoconazole, lopinavir and ritonavir, paritaprevir and...
- Moderate CYP3A inhibitors: aprepitant, ciprofloxacin, conivaptan, crizotinib, cyclosporine, diltiazem, dronedarone, erythromycin, fluconazole, fluvoxamine, imatinib, verapamil
- Strong CYP2B6 inhibitor: ticlopidine
What rules you out
- 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
- Patients who have a known inherited syndrome as the cause for hormone over secretion (i.e., Carney Complex, McCune-Albright syndrome, Multiple endocrine neoplasia (MEN) 1
- Patients with a diagnosis of glucocorticoid-remedial aldosteronism (GRA)
- Patients with cyclic Cushing's syndrome defined by any measurement of UFC over the previous 1 months within normal range
- Patients with pseudo-Cushing's syndrome, i.e., non-autonomous hypercortisolism due to overactivation of the hypothalamic-pituitary-adrenal (HPA) axis in uncontrolled depression, anxiety, obsessive compulsive disorder...
- Patients who have undergone major surgery within 1 month prior to screening
- Patients with serum K+\< 3.5 while on replacement treatment
- Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1C \>8%
- Patients who have clinically significant impairment in cardiovascular function or are at risk thereof, as evidenced by congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia...
- Patients with liver disease or history of liver disease such as cirrhosis, chronic active hepatitis B and C, or chronic persistent hepatitis, or patients with abnormal alanine transferase (ALT) or aspartate...
- Patients with estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m2
- Patients not biochemically euthyroid
- Patients who have any current or prior medical condition that can interfere with the conduct of the study or the evaluation of its results, such as
- History of immunocompromise, including a positive HIV test result (ELISA and Western blot). An HIV test will not be required, however, previous medical history will be reviewed
- Presence of active or suspected acute or chronic uncontrolled infection
- History of, or current alcohol misuse/abuse in the 12 month period prior to screening
- Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control. If a woman is participating in the trial then one form of contraception...
- Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to screening or patients who have previously been treated with seliciclib
- Patients with any ongoing or likely to require additional concomitant medical treatment to treat CD
- Patients who have received pituitary irradiation within the last 5 years prior to the baseline visit
- Patients who have been treated with radionuclide at any time prior to study entry
- Patients with known hypersensitivity to seliciclib
- Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study
- Patients with hepatitis B surface antigen (HbsAg) positivity
- Patients with hepatitis C antibody (anti-HCV) positivity
- Patients with prolonged QTcF on screening electrocardiogram (QTcF \>450 msec)
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.