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Open-label Treatment in Cushing's Syndrome (OPTICS)

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ClinicalTrials.gov Identifier: NCT03621280
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Cortendo AB

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
Cushing Syndrome Cushing Disease Drug: Levoketoconazole 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open-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 : January 7, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : June 2021


Arm Intervention/treatment
Experimental: Levoketoconazole
Levoketoconazole taken twice daily up to 1200 mg daily
Drug: Levoketoconazole
Levoketoconazole up to 1200 mg daily
Other Name: COR-003




Primary Outcome Measures :
  1. Changes from Baseline in 24-h UFC [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

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): NCT03621280


Contacts
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Contact: Cortendo AB 610-254-9200 OPTICS@cortendo.com
Contact: Cortendo AB Study Contact 610-254-9200 OPTICS@cortendo.com

  Show 41 Study Locations
Sponsors and Collaborators
Cortendo AB
Investigators
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Study Director: Xavier Valencia, MD Cortendo AB

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Responsible Party: Cortendo AB
ClinicalTrials.gov Identifier: NCT03621280     History of Changes
Other Study ID Numbers: COR-2017-OLE
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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ACTH-Secreting Pituitary Adenoma
Pituitary ACTH Hypersecretion
Cushing Syndrome
Syndrome
Disease
Pathologic Processes
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pituitary Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site