Open-label Treatment in Cushing's Syndrome (OPTICS)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03621280 |
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Recruitment Status :
Active, not recruiting
First Posted : August 8, 2018
Last Update Posted : August 3, 2021
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Sponsor:
Cortendo AB
Information provided by (Responsible Party):
Cortendo AB
- Study Details
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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 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | N/A |
| 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 : | June 2023 |
| Estimated Study Completion Date : | June 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Cushing disease
MedlinePlus related topics:
Cushing's Syndrome
Drug Information available for:
Levoketoconazole
| Arm | Intervention/treatment |
|---|---|
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Experimental: Levoketoconazole
Levoketoconazole taken twice daily up to 1200 mg daily
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Drug: Levoketoconazole
Levoketoconazole up to 1200 mg daily
Other Name: COR-003 |
Primary Outcome Measures :
- 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
- 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
- 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:
- Completed the Extended Evaluation Phase of Study COR-2012-01 (i.e. M12)
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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.
- Currently in a named patient program or other Expanded Access Program receiving levoketoconazole
- Were levoketoconazole-naïve prior to entry and received early rescue therapy with open-label levoketoconazole in Study COR-2017-01.
- 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.
- 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:
- 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.
- Scheduled for surgery for treatment of CS or received surgery for treatment of CS within the 6 weeks prior to Screening.
- Treated with mitotane within 6 months prior to 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).
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
Locations
Show 30 study locations
Sponsors and Collaborators
Cortendo AB
Investigators
| Study Chair: | Fredric Cohen, MD | Cortendo AB |
| Responsible Party: | Cortendo AB |
| ClinicalTrials.gov Identifier: | NCT03621280 |
| Other Study ID Numbers: |
COR-2017-OLE |
| First Posted: | August 8, 2018 Key Record Dates |
| Last Update Posted: | August 3, 2021 |
| Last Verified: | August 2021 |
| 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 |