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Study to Evaluate CORT125134 in Patients With Cushing's Syndrome

This study is currently recruiting participants.
Verified June 2017 by Corcept Therapeutics
Sponsor:
ClinicalTrials.gov Identifier:
NCT02804750
First Posted: June 17, 2016
Last Update Posted: June 19, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Corcept Therapeutics
  Purpose

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 Intervention Phase
Cushing's Syndrome Drug: CORT125134 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Corcept Therapeutics:

Primary Outcome Measures:
  • General safety of CORT125134 in patients with endogenous Cushing's syndrome. [ Time Frame: 12 months ]
    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:
  • The evidence of reduction in cortisol activity following treatment of CORT125134 in patients with endogenous Cushing's syndrome. [ Time Frame: 12 months ]
    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.


Estimated Enrollment: 30
Study Start Date: June 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Drug: CORT125134

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 12 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
  Contacts and Locations
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


Contacts
Contact: Clinical Study Lead cort451@corcept.com

Locations
United States, Colorado
Recruiting
Aurora, Colorado, United States, 80045
United States, Florida
Recruiting
Fort Lauderdale, Florida, United States, 33312
Recruiting
Miami, Florida, United States, 33136
United States, Indiana
Recruiting
Indianapolis, Indiana, United States, 46202
United States, Minnesota
Recruiting
Rochester, Minnesota, United States, 55905
United States, Pennsylvania
Recruiting
Pittsburgh, Pennsylvania, United States, 15212
United States, Virginia
Recruiting
Richmond, Virginia, United States, 23119
United States, Washington
Recruiting
Seattle, Washington, United States, 98122
Hungary
Recruiting
Budapest, Hungary
Recruiting
Pecs, Hungary
Italy
Recruiting
Cuneo, Italy
Recruiting
Messina, Italy
Recruiting
Milano, Italy
Recruiting
Naples, Italy
Recruiting
Orbassano, Italy
Recruiting
Roma, Italy
Recruiting
Siena, Italy
Recruiting
Torino, Italy
Netherlands
Recruiting
Leiden, Netherlands
Recruiting
Rotterdam, Netherlands
United Kingdom
Recruiting
Salford, Manchester, United Kingdom
Sponsors and Collaborators
Corcept Therapeutics
Investigators
Study Director: Andreas G Moraitis, MD Corcept Therapeutics
  More Information

Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT02804750     History of Changes
Other Study ID Numbers: CORT125134-451
First Submitted: June 15, 2016
First Posted: June 17, 2016
Last Update Posted: June 19, 2017
Last Verified: June 2017
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