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



Status:Recruiting
Conditions:Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:2/7/2019
Start Date:September 26, 2017
End Date:February 28, 2020
Contact:Cortendo AB
Email:LOGICS@cortendo.com
Phone:610-254-9200

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A Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open Label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S, 4R-ketoconazole) in the Treatment of Endogenous Cushing's Syndrome

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

This is a double-blind, randomized, placebo-controlled withdrawal and rescue/restoration
study in subjects with endogenous CS that will assess efficacy, safety, tolerability, and PK
of levoketoconazole. There are two populations (cohorts) of subjects: (1) subjects which were
previous levoketoconazole study completers and (2) subjects that are levoketoconazole
treatment naïve subjects.

Study methodology varies by cohort prior to randomization only. Following initial screening
(washout as needed) and Dose Titration and Maintenance Periods, as applicable, this study
will be conducted in two double-blind phases (a Withdrawal Phase and a Restoration Phase).
The levoketoconazole-naïve cohort will need to go through the Dose Titration and Maintenance
Phase. The longest anticipated total study participation duration is approximately 51 weeks.

INCLUSION CRITERIA:

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 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.

EXCLUSION CRITERIA:

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.
We found this trial at
13
sites
Ann Arbor, Michigan 48109
Principal Investigator: Tobias Else, MD
Phone: 734-764-4048
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Atlanta, Georgia 30322
Principal Investigator: Adriana Ioachimescu
Phone: 404-778-7427
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Atlanta, GA
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Baltimore, Maryland 21287
Principal Investigator: Roberto Salvatori, MD
Phone: 410-955-2812
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Baltimore, MD
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Chicago, Illinois 60611
Principal Investigator: Mark Molitch, MD
Phone: 312-908-9002
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Chicago, IL
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Fort Lauderdale, Florida 33312
Principal Investigator: Sam Lerman, MD
Phone: 957-963-7191
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Fort Lauderdale, FL
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Los Angeles, California 90033
Principal Investigator: John Carmichael
Phone: 323-865-1225
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Los Angeles, CA
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Los Angeles, California 90048
Principal Investigator: Ning-Ai Liu, MD
Phone: 424-315-4489
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Los Angeles, CA
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Los Angeles, California 90095
Principal Investigator: Anthony Heaney, MD, PhD
Phone: 310-825-5874
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Los Angeles, CA
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New York, New York 10065
Principal Investigator: Eliza Geer
Phone: 646-888-1365
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New York, NY
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420 East North Avenue
Pittsburgh, Pennsylvania 15212
Principal Investigator: Murray Gordon
Phone: 412-359-5143
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Pittsburgh, PA
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Portland, Oregon 97239
Principal Investigator: Maria Fleseriu, MD
Phone: 503-494-9546
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Portland, OR
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Saint Louis, Missouri 63110
Principal Investigator: Julie Silverstein
Phone: 314-747-5371
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Saint Louis, MO
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Sofia,
Principal Investigator: Zdravko Kamenov, MD PhD DMSc
Phone: +00359 888 956479
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Sofia,
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