Relacorilant for Endogenous Cushing Syndrome Treatment: A Safety Study
This phase 2 study aims to evaluate the long-term safety of Relacorilant in individuals with Endogenous Cushing Syndrome, by monitoring the number of participants who experience treatment-emergent adverse events.
relacorilant
ACTH Syndrome, Ectopic+30
+ Adenocarcinoma
+ Adrenal Cortex Diseases
Treatment Study
Summary
Study start date: May 7, 2018
Actual date on which the first participant was enrolled.This study focuses on the continued use of Relacorilant (CORT125134), a powerful and selective glucocorticoid receptor (GR) antagonist. The purpose is to treat patients who have previously participated in a study involving Relacorilant for Endogenous Cushing Syndrome, a condition where the body produces too much cortisol. The study aims to provide ongoing treatment to those who have shown improvement and could benefit from further use of Relacorilant. The importance lies in potentially offering a long-term solution for managing the signs and symptoms of this syndrome. Participants in this study will continue to take Relacorilant once daily, as long as they are benefiting from the treatment, as determined by the investigator. The dose may be adjusted based on the individual's response and tolerability. The primary outcome measured is the long-term safety of Relacorilant, specifically the number of participants who experience treatment-emergent adverse events (TEAEs). These events are assessed using a standardized system called CTCAE v4.0.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.125 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Major Inclusion Criteria: * Have completed a Corcept-sponsored study of relacorilant in endogenous Cushing syndrome with at least 80% compliance with the dosing schedule. * According to the Investigator's opinion will benefit from continuing treatment with relacorilant Exclusion Criteria: * Major Exclusion Criteria: * Premature discontinuation from a relacorilant parent study. * Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism * Has poorly controlled hypertension * Has Stage ≥ 4 renal failure
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 48 locations
Site 35
Stanford, United StatesSite 39
Torrance, United StatesSite 50
Miami, United States