A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome.

Completed · Phase 3 · Has a placebo group

Conditions studied: Endogenous Cushing's Syndrome

In brief

This is a double-blind, randomized, placebo-controlled withdrawal and rescue/restoration study in subjects with endogenous Cushing's Syndrome (CS) previously treated with single-arm, open-label levoketoconazole that will assess efficacy, safety, tolerability, and pharmacokinetics of levoketoconazole.

Key facts

Study ID

NCT03277690

Run by

Cortendo AB

People needed

84

Starts

2017-09-26

Expected to finish

2020-08-31

Last updated by the study team

2022-11-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• SONICS STUDY COMPLETERS:
• Completed the final SONICS visit (M12) and have demonstrated maintenance of clinical response on a stable Therapeutic Dose of levoketoconazole for at least 12 weeks prior to study entry.
• ALL OTHERS:
• Confirmed newly diagnosed, persistent or recurrent endogenous Cushing's syndrome of any etiology, except secondary to malignancy (including pituitary or adrenal carcinoma).
• Elevated mean 24-hour Urinary Free Cortisol (UFC) levels at least 1.5X upper limit of the normative range of the study's central laboratory assay and from a minimum of three measurements from adequately collected urine.
• Presence of abnormal values from at least one of these two diagnostic tests:
• Abnormal Dexamethasone Suppression Test (DST) OR
• Elevated late night salivary cortisol concentrations (at least two measurements) each greater than the upper limit of the study's central laboratory normative range
• Non-candidates for CS-specific surgery, refuse surgery or surgery will be delayed until after study completion and agree to complete this study prior to surgery.
• If post-surgical for CS-specific surgery, then no significant post-operative sequelae remain and the risk of such sequelae is considered negligible.

You may not qualify if…

• Subjects will be excluded from the study if ANY of the following criteria are met (NOTE: exclusion criteria apply to and must be assessed in both cohorts):
• Enrolled in SONICS but have not completed SONICS through Visit M12.
• Pseudo-Cushing's syndrome based on assessment of the Investigator.
• Cyclic Cushing's syndrome with multi-week periods of apparent spontaneous CS remission.
• Non-endogenous source of hypercortisolism, including pharmacological corticosteroids or ACTH.
• Radiotherapy of any modality directed against the source of hypercortisolism within the last 5 years.
• Treatment with mitotane within 6 months of enrollment.
• History of malignancy, including adrenal or pituitary carcinomas (other than low-risk, well-differentiated carcinomas of thyroid, breast or prostate that are very unlikely to require further treatment in the opinion of the treating physician, or squamous cell or basal cell carcinoma of the skin).
• Clinical or radiological signs of compression of the optic chiasm.

Where it is running

• Keck Medical Center University of Southern California HCII, Internal Medicine - Keck Hospital — Los Angeles, California, United States
• Cedars-Sinai Medical Center, Cedars-Sinai Pituitary Center — Los Angeles, California, United States
• UCLA School of Medicine, Medicine/Endocrinology Department — Los Angeles, California, United States
• The Center for Diabetes and Endocrine Care — Fort Lauderdale, Florida, United States
• Emory University, Neurosurgery — Atlanta, Georgia, United States
• Northwestern University, Medicine - Endocrinology — Chicago, Illinois, United States
• Johns Hopkins University, Endocrinology Department — Baltimore, Maryland, United States
• University of Michigan, Comprehensive Endocrine Research, Internal Medicine - MEND — Ann Arbor, Michigan, United States
• Washington University School of Medicine, Endocrinology — St Louis, Missouri, United States
• Columbia University, College of P&S Medicine/Neuro-endocrine Unit — New York, New York, United States
• Memorial Sloan Kettering Cancer Center, Endocrinology — New York, New York, United States
• Oregon Health & Science University, Neurological Surgery — Portland, Oregon, United States
• Allegheny Neuroendocrinology Center, West Penn Allegheny Health System — Pittsburgh, Pennsylvania, United States
• Alexandovska University Hospital, Clinic of Endocrinology & Metabolic Diseases — Sofia, Bulgaria
• University Multiprofile Hospital for Active Treatment "Aleksandrovska" EAD Clinic of Endocrinology and Metabolic Diseases — Sofia, Bulgaria
• University Specialized Hospital for Active Treatment in Endocrinology (USHATE) I Klinika — Sofia, Bulgaria
• Rigshospitalet, Copenhagen University Hospital, Endocrinology Department — Copenhagen, Denmark
• APHM Hôpital de la Conception, Service d'Endocrinologie, Diabète et Maladies Métaboliques — Marseille, Cedex 5, France
• Evangelismos Athens General Hospital, Department of Endocrinology — Athens, Greece
• General Hospital of Athens 'G. Gennimatas', Department of Endocrinology-Diabetes Centre — Athens, Greece
• General Hospital of Athens 'Laiko', "National and Kapodistrian University of Athens Medical School Pathophysiology - Endocrinology" — Athens, Greece
• University General Hospital of Ioannina, Department of Endocrinology — Ioannina, Greece
• Hippokration General Hospital, "Endocrinology and Diabetes Department — Thessaloniki, Greece
• Semmelweis Egyetem II. Belgyógyászati Klinika A.épület I.emelet ODM-labor — Budapest, Hungary
• Bnai Zion Medical Center, Institute of Endocrinology — Haifa, Israel

Full record on ClinicalTrials.gov

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