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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:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with UFC above the upper limit of normal (ULN) but reduced by ≥50% from baseline at study completion
Number of participants with a normalized 24-hour urinary free cortisol (UFC) at study completion
Secondary outcome measures
Blood pressure
Change in quality of life measured using the CushingQOL questionnaire
Change in tumor size on pituitary MRI
+8 moreTrial 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
499 Previous Clinical Trials
164,844 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
1 Trials studying Cushing's Disease
4 Patients Enrolled for Cushing's Disease
Ning-Ai Liu, MD, PhDStudy DirectorCedars-Sinai Medical Center
2 Previous Clinical Trials
4 Total Patients Enrolled
1 Trials studying Cushing's Disease
4 Patients Enrolled for Cushing's Disease
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are currently enrolled in the experiment?
"No, this clinical trial is not enrolling participants presently. It originally posted on the 2nd of November 2018 and was recently edited on May 24th 2022. If you're looking for alternative studies related to Cushing's Disease or Seliciclib, there are currently 10 trials accepting patients."
Answered by AI
Has Seliciclib received the necessary authorization from the FDA?
"Due to a lack of efficacy research, Seliciclib was assigned an overall safety score of 2. Nonetheless, there is some data suggesting that the drug is safe for use in clinical trials."
Answered by AI
Is the recruitment process of this experiment currently underway?
"Per the information found on clinicaltrials.gov, this medical experiment is not currently recruiting patients. Originally listed in November 2018 and last updated May 2022, there are 10 other studies actively enrolling individuals at present."
Answered by AI
To what extent have previous studies explored the use of Seliciclib?
"Currently, there is one active clinical trial of Seliciclib in progress with none being conducted at Phase 3. It's primary location is located in Los Angeles, California but it has an additional site open for participating patients."
Answered by AI
Who else is applying?
What site did they apply to?
Cedars-Sinai Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
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