Study to Evaluate CORT125134 in Patients With Cushing's Syndrome
| Status: | Completed |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 11/17/2018 |
| Start Date: | June 2016 |
| End Date: | September 2018 |
Phase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushing's Syndrome
Cushing's syndrome is a relatively rare disorder caused by prolonged exposure to high levels
of the glucocorticoid hormone cortisol. Cushing's syndrome may result from elevated
endogenous or exogenous sources of cortisol. Endogenous Cushing's syndrome resulting from
cortisol overproduction by the adrenal glands is the subject of this protocol.
Patients with exogenous Cushing's syndrome, which develops as a side effect of chronic
administration of high doses of glucocorticoids, are not eligible for enrollment in this
study.
The purpose of this study is to evaluate the safety and efficacy of CORT125134 for treatment
of endogenous Cushing's syndrome. The multicenter study will be conducted in the United
States and in Europe.
of the glucocorticoid hormone cortisol. Cushing's syndrome may result from elevated
endogenous or exogenous sources of cortisol. Endogenous Cushing's syndrome resulting from
cortisol overproduction by the adrenal glands is the subject of this protocol.
Patients with exogenous Cushing's syndrome, which develops as a side effect of chronic
administration of high doses of glucocorticoids, are not eligible for enrollment in this
study.
The purpose of this study is to evaluate the safety and efficacy of CORT125134 for treatment
of endogenous Cushing's syndrome. The multicenter study will be conducted in the United
States and in Europe.
This is a Phase 2, open-label study with two dose groups, each with a two-step dose
escalation, designed to evaluate the safety and efficacy of CORT125134 for the treatment of
endogenous Cushing's syndrome. CORT125134 will be administered orally once daily for 16 weeks
with dose escalations occuring every 4 weeks.
PK profiles will be generated at every dose level. A data review committee will review PK and
safety data and will recommend the final plan for dose escalation in Group 2.
escalation, designed to evaluate the safety and efficacy of CORT125134 for the treatment of
endogenous Cushing's syndrome. CORT125134 will be administered orally once daily for 16 weeks
with dose escalations occuring every 4 weeks.
PK profiles will be generated at every dose level. A data review committee will review PK and
safety data and will recommend the final plan for dose escalation in Group 2.
Inclusion Criteria:
1. Has a confirmed diagnosis of endogenous Cushing's syndrome.
2. Requires medical treatment of hypercortisolemia.
3. Meets at least one of the following criteria:
1. Has type 2 diabetes mellitus.
2. Has impaired glucose tolerance.
3. Has hypertension.
Exclusion Criteria:
1. Has non-endogenous source of hypercortisolemia
2. Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
3. Has poorly controlled hypertension
4. Has Stage ≥ 4 renal failure
We found this trial at
13
sites
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