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OPTICS: Open-label Treatment in Cushing's Syndrome

Sponsor
Cortendo AB (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03621280
Collaborator
(none)
60
Enrollment
30
Locations
1
Arm
52.8
Anticipated Duration (Months)
2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Open-Label Extension StudyOpen-Label Extension Study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing's Syndrome
Actual Study Start Date :
Jan 7, 2019
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Levoketoconazole

Levoketoconazole taken twice daily up to 1200 mg daily

Drug: Levoketoconazole
Levoketoconazole up to 1200 mg daily
Other Names:
  • COR-003

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes from Baseline in 24-h UFC [From Baseline to final study visit or up to a maximum of 3 years, whichever comes first.]

      Changes or shifts from baseline in mUFC

    2. Changes from Baseline in Late Night Salivary Cortisol [From Baseline to final study visit or up to a maximum of 3 years, whichever comes first.]

      Changes or shifts from baseline in late night salivary cortisol levels

    3. Changes from Baseline in AEs/SAEs/AESI as assessed by CTCAE V4.03 [From Baseline to final study visit or up to a maximum of 3 years, whichever comes first.]

      Changes from Baseline in the incidence and severity of AEs, SAEs, AESIs

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 may require re-establishment of the Therapeutic Dose via titration. All subjects who have had a break in therapy should be discussed with the Medical Monitor to determine the starting dose of levoketoconazole. 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.

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

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

    3. Achieved a clinically meaningful partial response (with reduction of UFC) in Study COR-2017-01 at dose level 7 or at a maximally tolerated dose of levoketoconazole but did not meet the randomization criteria for Study COR-2017-01 at the end of the Dose Titration and Maintenance Phase when randomization was open.

    4. 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 must receive at least 1 dose of levoketoconazole before transitioning to this study.)

    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Center for Diabetes and Endocrine Care Fort Lauderdale Florida United States 33312
    2 Emory University Atlanta Georgia United States 30322
    3 Washington University School of Medicine Saint Louis Missouri United States 63110
    4 University of New Mexico HSC - HSC Sponsored Projects Office Albuquerque New Mexico United States 87131
    5 Columbia University Medical Center New York New York United States 10032
    6 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    7 Cleveland Clinic Cleveland Ohio United States 44195
    8 Oregon Health & Science University Portland Oregon United States 97239
    9 Sveti Georgy University Hospital Clinic of Endocrinology and Metabolic Diseases Plovdiv Bulgaria 4000
    10 Alexandovska University Hospital Sofia Bulgaria 1431
    11 University Specialized Hospital for Active Treatment in Endocrinology Sofia Bulgaria 1431
    12 APHM Hôpital de la Conception Marseille France 13385
    13 General Hospital of Athens Evangelismos Department of Endocrinology and Diabete Athens Greece 10676
    14 Hippokration General Hospital Endocrinology and Diabetes Department Thessaloníki Greece 54642
    15 Semmelweis Egyetem II. Belgyógyászati Klinika Budapest Hungary 1083
    16 Bnai Zion Medical Center Endocrinology Institute Haifa Israel 34802
    17 Rabin Medical Center, Beilinson Campus Petah tikva Israel 49100
    18 Tel Aviv-Sourasky Medical Center Institute Endocrinology Metabolism & Hypertension Tel Aviv Israel 6423906
    19 Clinica Endocrinologia malattie del Metabolismo Ancona Italy 60126
    20 AOU Policlinico G. Martino Sezione di Endocrinologia Messina Italy 98125
    21 Via Sergio Pansini 5 Uni Naples FedericoII Dept of Molecular&Clinical Endocrinology&Oncology Naples Italy 80131
    22 Policlinico Universitario Sant'Andrea Roma Italy 00189
    23 University of Turin Turin Italy 10126
    24 Erasmus Medical Center Rotterdam Netherlands 3015 CE
    25 Instytut Centrum Zdrowia Matki Polki Łódź Poland 93-338
    26 Institutul National de Endocrinologie C.I. Parhon Cluj-Napoca Romania 400349
    27 Spitalul Clinic Judetean de Urgenta Cluj-Napoca Cluj-Napoca Romania 400349
    28 Spitalul Clinic Judetean Mures Târgu-Mureş Romania 540139
    29 Hospital Universidad De La Ribera Alzira Spain 46600
    30 Hospital Universitario Ramón y Cajal Madrid Spain 28034

    Sponsors and Collaborators

    • Cortendo AB

    Investigators

    • Study Chair: Fredric Cohen, MD, Cortendo AB

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cortendo AB
    ClinicalTrials.gov Identifier:
    NCT03621280
    Other Study ID Numbers:
    • COR-2017-OLE
    First Posted:
    Aug 8, 2018
    Last Update Posted:
    Aug 3, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    ACTH-Secreting Pituitary Adenoma
    Pituitary ACTH Hypersecretion
    Cushing Syndrome
    Syndrome

    Study Results

    No Results Posted as of Aug 3, 2021