Open-label Treatment in Cushing's Syndrome



Status:Recruiting
Conditions:Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:January 7, 2019
End Date:June 2021
Contact:Cortendo AB
Email:OPTICS@cortendo.com
Phone:610-254-9200

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An Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing's Syndrome

This is a long-term, open-label extension study of levoketoconazole in subjects with
endogenous Cushing's Syndrome.

This is a long-term, OLE study of levoketoconazole in subjects with endogenous CS who have
completed one or both parent studies or otherwise potentially qualify for this study, as
defined in the eligibility criteria.

Inclusion Criteria:

1. Completed the Extended Evaluation Phase of Study COR-2012-01 (i.e. M12)

2. Completed the Restoration Phase of Study COR-2017-01 (i.e. RES2)

NOTE: Subjects meeting criteria 1 or 2 above who have had a break in therapy may be
eligible only after discussion with the Medical Monitor. If eligible, such subjects
should resume levoketoconazole at or below the prior therapeutic dose at the
discretion of the Investigator. Prior to resuming treatment with levoketoconazole,
other therapies for Cushing's Syndrome must undergo an appropriate washout period,
with minimum durations as follows:

- Ketoconazole or metyrapone: 2 weeks;

- Dopamine agonists: bromocriptine (2 weeks), cabergoline (8 weeks);

- Octreotide acetate LAR, lanreotide Autogel, pasireotide LAR: 12 weeks;

- Lanreotide SR: 8 weeks;

- Octreotide acetate (immediate release) or short-acting pasireotide: 1 week;

- Mifepristone (RU 486, KORLYM): 4 weeks;

- Megestrol acetate or medroxyprogesterone acetate (and selected other synthetic
progestins): 6 weeks.

3. Currently in a named patient program or other Expanded Access Program receiving
levoketoconazole

4. Were levoketoconazole-naïve prior to entry and received early rescue therapy with
open-label levoketoconazole in Study COR-2017-01.

5. Were levoketoconazole-naïve prior to entry and were enrolled in Study COR-2017-01 in
the Dose Titration and Maintenance Phase when randomization was closed. (NOTE: Such
subjects may continue in Study COR-2017-01 until a therapeutic dose has been
established or until the end of the Dose Titration and Maintenance Phase, whichever
comes first).

Exclusion Criteria:

1. Discontinued levoketoconazole while participating in Study COR-2012-01 or Study
COR-2017-01 or a named patient program or other Expanded Access program, due to safety
or tolerability concerns or lack of efficacy.

2. Scheduled for surgery for treatment of CS or received surgery for treatment of CS
within the 6 weeks prior to Screening.

3. Treated with mitotane within 6 months prior to enrollment.

4. 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).
We found this trial at
11
sites
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Julie Silverstein, MD
Phone: 314-747-5371
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Adriana Ioachimescu, MD
Phone: 404-779-3746
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Ning-Ai Liu, MD
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Maria Fleseriu, MD
Phone: 503-494-9546
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Albuquerque, New Mexico 87131
Principal Investigator: Patricia Kapsner, MD
Phone: 617-726-7473
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Albuquerque, NM
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Ann Arbor, Michigan 48109
Principal Investigator: Tobias Else, MD
Phone: 734-764-4048
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Ann Arbor, MI
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Mark Molitch, MD
Phone: 312-908-9002
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Chicago, IL
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Los Angeles, California 90033
Principal Investigator: John Carmichael, MD
Phone: 323-865-1225
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Los Angeles, CA
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Los Angeles, California
Principal Investigator: Anthony Heany, MD
Phone: 310-825-5874
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Los Angeles, CA
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Eliza Geer, MD
Phone: 646-888-1365
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Plovdiv,
Principal Investigator: Maria Orbetzova, MD
Phone: +35932602486
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Plovdiv,
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