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Cyclin-Dependent Kinase Inhibitor
Seliciclib for Cushing's Disease
Phase 2
Recruiting
Led By Shlomo Melmed, MD
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- Pituitary macroadenoma (>1 cm) on MRI or inferior petrosal sinus sampling (IPSS) central to peripheral ACTH gradient >2 at baseline and >3 after corticotropin-releasing hormone (CRH) stimulation
Patients with confirmed pituitary origin of excess adrenocorticotropic hormone (ACTH) production:
Must not have
Patients with hepatitis B surface antigen (HbsAg) positivity
Patients with cyclic Cushing's syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will test the safety and effectiveness of a new drug, seliciclib, for treating Cushing disease. The trial will last 4 weeks and will involve patients who have newly diagnosed, persistent, or recurrent Cushing disease.
Who is the study for?
Adults with Cushing's disease from a pituitary source, who have high cortisol levels and are not currently well-controlled on other treatments. They must be at least 18 years old, have completed specific medication washout periods, and cannot have had pituitary radiation in the last 5 years or any major surgery within the past month.
What is being tested?
The trial is testing Seliciclib, an oral medication given for four weeks to see if it's safe and effective for treating Cushing's disease. It’s an open-label study funded by the FDA Office of Orphan Products Development.
What are the potential side effects?
Potential side effects of Seliciclib may include sensitivity reactions, liver issues (as those with liver disease were excluded), possible heart problems (QTcF prolongation was a concern), as well as general risks associated with taking new medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a large pituitary tumor and specific test results showing a hormone imbalance.
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My condition is caused by an excess of ACTH from the pituitary gland.
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My Cushing disease has come back or hasn't gone away after surgery.
Select...
My condition is caused by excess ACTH from the pituitary gland.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have tested positive for hepatitis B.
Select...
I have cyclic Cushing's syndrome.
Select...
I have not been in a drug trial or taken seliciclib in the last month.
Select...
My Cushing's syndrome is caused by ACTH from outside the pituitary gland.
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I have high cortisol levels due to adrenal tumors or a specific adrenal gland condition.
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I have been diagnosed with pseudo-Cushing's syndrome.
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I am not pregnant, breastfeeding, or if capable of becoming pregnant, I am using effective birth control.
Select...
My MRI shows pressure near my optic nerve but my vision is normal.
Select...
I have a genetic condition causing hormone overproduction.
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I have been diagnosed with GRA.
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I have or had liver disease.
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I have heart problems or am at risk for them.
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My diabetes is not well-managed, with an HbA1C level over 8%.
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I have received radionuclide treatment before.
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My kidney function is reduced, with an eGFR below 45.
Select...
I do not have any ongoing or suspected serious infections.
Select...
My potassium levels are below 3.5 despite taking supplements.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: SeliciclibExperimental Treatment1 Intervention
80 mg each day oral seliciclib for 4 weeks
Find a Location
Who is running the clinical trial?
Cedars-Sinai Medical CenterLead Sponsor
512 Previous Clinical Trials
163,351 Total Patients Enrolled
Shlomo Melmed, MDPrincipal Investigator - Cedars-Sinai Medical Center
Cedars-Sinai Medical Center, Sound Physicians Platinum Group Pc
University Of Cape Town (Medical School)
7 Previous Clinical Trials
1,538 Total Patients Enrolled
Ning-Ai Liu, MD, PhDStudy DirectorCedars-Sinai Medical Center
2 Previous Clinical Trials
4 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to seliciclib.I have tested positive for hepatitis B.You have had problems with alcohol in the past year.I have not been in a drug trial or taken seliciclib in the last month.I have a large pituitary tumor and specific test results showing a hormone imbalance.My Cushing's syndrome is caused by ACTH from outside the pituitary gland.My condition is caused by an excess of ACTH from the pituitary gland.I have high cortisol levels due to adrenal tumors or a specific adrenal gland condition.I have been diagnosed with pseudo-Cushing's syndrome.You do not have normal thyroid function.I am not pregnant, breastfeeding, or if capable of becoming pregnant, I am using effective birth control.My MRI shows pressure near my optic nerve but my vision is normal.I have a genetic condition causing hormone overproduction.I have been diagnosed with GRA.I have not taken mifepristone in the last 2 weeks.I have or had liver disease.I have cyclic Cushing's syndrome.I have heart problems or am at risk for them.I have stopped taking certain medications that affect my liver enzymes as required.My Cushing disease has come back or hasn't gone away after surgery.My vision has been unstable for less than 6 months.My diabetes is not well-managed, with an HbA1C level over 8%.I have received radionuclide treatment before.I may need more treatment for Crohn's disease.I am 18 years old or older.Your heart's electrical activity is abnormal, as shown on a screening test.Your ACTH levels are either normal or high.I have had pituitary gland radiation treatment within the last 5 years.I have not taken steroidogenesis inhibitors in the last 2 weeks.My condition is caused by excess ACTH from the pituitary gland.I haven't taken short-acting pasireotide in the last 2 weeks or long-acting in the last 4 weeks.My kidney function is reduced, with an eGFR below 45.I do not have any ongoing or suspected serious infections.You have consistently high levels of cortisol in your urine for at least two days in a row.I had major surgery less than a month ago.I have not taken dopamine agonists like cabergoline in the last 4 weeks.I am not taking any strong drugs that affect liver enzymes.My potassium levels are below 3.5 despite taking supplements.You have tested positive for hepatitis C antibodies.I have completed the required break from my Cushing disease medication.
Research Study Groups:
This trial has the following groups:- Group 1: Seliciclib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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