Treatment of Cushing's Disease With R-roscovitine
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02160730|
Recruitment Status : Terminated (NIH grant ended.)
First Posted : June 11, 2014
Results First Posted : October 29, 2021
Last Update Posted : November 4, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cushings Disease||Drug: R-roscovitine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Pituitary Cushing Disease With a Selective CDK Inhibitor, R-roscovitine|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||October 2018|
|Actual Study Completion Date :||October 2018|
• R-roscovitine 400 mg oral administration twice daily for 4 days every week for total of 4 weeks.
See Arm Description
- Number of Participants With a Normalized 24 Hour Urinary Free Cortisol After 4 Weeks [ Time Frame: Baseline, 4 weeks ]To evaluate the efficacy of R-roscovitine 400 mg oral administration twice daily for 4 days every week for total of 4 weeks on normalizing 24 hour urinary free cortisol (24 h UFC) levels in CD patients. "Normalizing" is defined as having urine free cortisol levels within the normal range for that lab value.
- Change in Mean HbA1c Levels Between Baseline and 4 Weeks [ Time Frame: Baseline, 4 Weeks ]HbA1c levels are measured at baseline and at study end, these are averaged across all subjects.
- Number of Participants With Adverse Events [ Time Frame: Baseline, 4 weeks ]The number of participants that experience an adverse event between baseline and study end likely related to study drug as a measure of safety and tolerability.
- Number of Participants That Have a Visible Change in Tumor Size [ Time Frame: Baseline, 4 weeks ]A visible change in tumor size as determined by the investigator after reviewing MRI reports between baseline and 4 weeks of treatment.
- Number of Participants That Experience Changes in Clinical Signs of Hypercortisolemia [ Time Frame: Baseline, Week 4 ]The number of participants that achieved a urinary free cortisol level above the upper limit of the normal range but reduced by ≥50% from baseline at week 4.
- Fasting Glucose at Baseline and 4 Weeks [ Time Frame: Baseline, 4 Weeks ]Mean change between baseline and week 4 of fasting blood glucose levels.
- Plasma ACTH at Baseline and 4 Weeks [ Time Frame: Baseline, 4 weeks ]Mean change in Plasma ACTH between baseline and 4 weeks.
- Change in Clinical Symptoms [ Time Frame: Baseline, 4 weeks ]Change in typical Cushing's syndrome clinical signs and symptoms defined by mean weight at baseline and 4 weeks.
- Changes in Serum Cortisol Between Baseline and 4 Weeks [ Time Frame: Baseline, 4 weeks ]Mean serum cortisol values at baseline and 4 weeks
- Change in Systolic Blood Pressure [ Time Frame: Baseline, 4 weeks ]Mean change in systolic blood pressure between baseline and 4 weeks.
- Change in Diastolic Blood Pressure [ Time Frame: Baseline, 4 weeks ]Mean diastolic blood pressure between baseline and 4 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160730
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||Shlomo Melmed, MD||Cedars-Sinai Medical Center|
|Study Director:||Ning-Ai Liu, MD, PhD||Cedars-Sinai Medical Center|