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This is an open-label extension study to evaluate the long-term safety of relacorilant in patients with endogenous Cushing syndrome who successfully completed participation in a Corcept-sponsored study of relacorilant and may benefit from continuing treatment.
This study is designed to allow continued therapy with relacorilant, a potent, selective glucocorticoid receptor (GR) antagonist in patients who have successfully completed participation of a Corcept-sponsored study of relacorilant (referred to as the "parent" study). Patients may qualify to enter this extension study if they complete their last treatment visit in their parent study and in the Investigator's opinion will benefit from continued treatment.
Once-daily dosing with relacorilant may continue for patients who receive clinical benefits (as judged by the Investigator) until relacorilant is commercially or otherwise available or the study is stopped by the Sponsor. A patient's dose may be maintained, reduced, or increased based on individual response and tolerability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| relacorilant (CORT125134) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| relacorilant | Drug | CORT125134 is supplied as capsules for oral dosing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long-term safety of relacorilant | Number of participants with treatment-emergent adverse events (TEAEs)as assessed by CTCAE v4.0 | 36 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Long-term benefit of relacorilant | Changes from Baseline as measured by glycated hemoglobin(HbA1c) and insulin resistance in patients with diabetes mellitus (DM) or glucose intolerance at Baseline in the parent study | 36 months |
| Long-term benefit of relacorilant |
Inclusion Criteria:
Major Inclusion Criteria:
Exclusion Criteria:
Major Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ying Ru, MD, PhD | Corcept Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 49 | Phoenix | Arizona | 85013 | United States | ||
| Site 35 |
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Changes from Baseline as measured by systolic and diastolic blood pressure (BP) by ambulatory BP measurements (ABPM) in patients with uncontrolled hypertension (HTN) at Baseline in the parent study and in patients with controlled HTN taking at least one anti-HTN medication. |
| 36 months |
| Long-term benefit of relacorilant | Changes from Baseline in weight as measured by Kg | 36 months |
| Long-term benefit of relacorilant | Changes from Baseline in waist circumference measured in cm | 36 months |
| Long-term benefit of relacorilant | Changes from Baselinein quality-of-life based on Cushing quality of life questionnaire 0 (worst) to 100 (best) | 36 months |
| Long-term benefit of relacorilant | Changes from Baseline in hypthalamic-pituitary-adrenal (HPA) axis markers (Plasma ACTH and Fasting Cortisol) and Sex steroid hormone (testosterone and estradiol) | 36 months |
| Stanford |
| California |
| 94305 |
| United States |
| Site 39 | Torrance | California | 90502 | United States |
| Site 50 | Miami | Florida | 33136 | United States |
| Site 10 | Atlanta | Georgia | 30318 | United States |
| Site 9 | Chicago | Illinois | 60611 | United States |
| Site 1 | Indianapolis | Indiana | 46202 | United States |
| Site 5 | Metairie | Louisiana | 70006 | United States |
| Site 27 | Baltimore | Maryland | 21287 | United States |
| Site 13 | Fall River | Massachusetts | 02721 | United States |
| Site 8 | Ann Arbor | Michigan | 48109 | United States |
| Site 36 | Rochester | Minnesota | 55905 | United States |
| Site 34 | Jackson | Mississippi | 39202 | United States |
| Site 3 | St Louis | Missouri | 63110 | United States |
| Site 55 | Reno | Nevada | 89511 | United States |
| Site 6 | Albany | New York | 12206 | United States |
| Site 24 | New York | New York | 10021 | United States |
| Site 4 | Wilmington | North Carolina | 28401 | United States |
| Site 43 | Cleveland | Ohio | 44195 | United States |
| Site 2 | Pittsburgh | Pennsylvania | 15212 | United States |
| Site 46 | Pittsburgh | Pennsylvania | 15213 | United States |
| Site 11 | Dallas | Texas | 75390 | United States |
| Site 7 | El Paso | Texas | 79935 | United States |
| Site 32 | Fort Worth | Texas | 76132 | United States |
| Site 12 | Houston | Texas | 77079 | United States |
| Site 14 | Vienna | 1090 | Austria |
| Site 51 | Nova Scotia | Canada |
| Site 16 | Munich | Germany |
| Site 42 | Würzburg | 97080 | Germany |
| Site 20 | Ramat Gan | 5265601 | Israel |
| Site 29 | Tel Aviv | 64239 | Israel |
| Site 40 | Ancona | 60126 | Italy |
| Site 44 | Messina | 98125 | Italy |
| Site 25 | Milan | 20145 | Italy |
| Site 21 | Naples | 80131 | Italy |
| Site 48 | Padova | 35128 | Italy |
| Site 52 | Torino | Italy |
| Site 33 | Rotterdam | 3015 GD | Netherlands |
| Site 47 | Krakow | 30-688 | Poland |
| Site 45 | Lublin | 20412 | Poland |
| Site 37 | Bucharest | 050474 | Romania |
| Site 31 | Bucharest | 10825 | Romania |
| Site 28 | Bucharest | 11863 | Romania |
| Site 53 | Alicante | Spain |
| Site 18 | Girona | Spain |
| Site 17 | Madrid | 28007 | Spain |
| Site 38 | Málaga | 29006 | Spain |
| Site 19 | Seville | Spain |
| ID | Term |
|---|---|
| D003480 | Cushing Syndrome |
| D047748 | Pituitary ACTH Hypersecretion |
| D000182 | ACTH Syndrome, Ectopic |
| D003924 | Diabetes Mellitus, Type 2 |
| D006973 | Hypertension |
| D018268 | Adrenocortical Carcinoma |
| D000306 | Adrenal Cortex Neoplasms |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009384 | Paraneoplastic Endocrine Syndromes |
| D010257 | Paraneoplastic Syndromes |
| D009369 | Neoplasms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D000310 | Adrenal Gland Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D000303 | Adrenal Cortex Diseases |
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| ID | Term |
|---|---|
| C000633444 | relacorilant |
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