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Study to Evaluate CORT125134 in Patients With Cushing's Syndrome

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ClinicalTrials.gov Identifier: NCT02804750
Recruitment Status : Active, not recruiting
First Posted : June 17, 2016
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cushing's Syndrome Drug: CORT125134 Phase 2

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushing's Syndrome
Study Start Date : June 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018


Arm Intervention/treatment
Experimental: CORT125134

Group 1: 100 mg/day for 4 weeks, then 150 mg/day for 4 weeks, then 200 mg/day for 4 weeks.

Group 2: 250 mg/day for 4 weeks, then 300 mg/day for 4 weeks, then 350 mg/day for 4 weeks, then 400 mg/day for 4 weeks.

Drug: CORT125134



Primary Outcome Measures :
  1. General safety of CORT125134 in patients with endogenous Cushing's syndrome. [ Time Frame: 16 weeks ]
    The safety profile of CORT125134 in patients with Cushing's syndrome as assessed by physical examination findings, vital signs, ECG results, clinical laboratory tests, adverse events (CTCAE v4.0) and concomitant medications.


Secondary Outcome Measures :
  1. The evidence of reduction in cortisol activity following treatment of CORT125134 in patients with endogenous Cushing's syndrome. [ Time Frame: 16 weeks ]
    The reduction in cortisol activity following treatment with CORT125134 in patients with endogenous Cushing's syndrome based on improvement in glucose control and/or blood pressure.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT02804750


  Show 25 Study Locations
Sponsors and Collaborators
Corcept Therapeutics
Investigators
Study Director: Andreas G Moraitis, MD Corcept Therapeutics

Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT02804750     History of Changes
Other Study ID Numbers: CORT125134-451
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Corcept Therapeutics:
Cushing's Syndrome
Cushing's Disease
Cushings
Hypercortisolemia
Cushingoid
Type 2 Diabetes
Impaired Glucose Intolerance
Hypertension
Adrenal Corticotrophic Hormone (ACTH)
Adrenocortical Carcinoma
Primary Pigmented Nodular Adrenal Disease (PPNAD)
Moon Facies
Dorsocervical Fat Pad
Adrenal Adenoma
Adrenal Carcinoma
Adrenal Autonomy
Cortisol

Additional relevant MeSH terms:
Syndrome
Cushing Syndrome
Disease
Pathologic Processes
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases