Cushing Syndrome Clinical Trial
— OPTICSOfficial title:
An Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing's Syndrome
Verified date | May 2023 |
Source | Cortendo AB |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a long-term, open-label extension study of levoketoconazole in subjects with endogenous Cushing's Syndrome.
Status | Completed |
Enrollment | 51 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. 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. 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. 6. 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). |
Country | Name | City | State |
---|---|---|---|
Bulgaria | Sveti Georgy University Hospital Clinic of Endocrinology and Metabolic Diseases | Plovdiv | |
Bulgaria | Alexandovska University Hospital | Sofia | |
Bulgaria | University Specialized Hospital for Active Treatment in Endocrinology | Sofia | |
France | APHM Hôpital de la Conception | Marseille | |
Greece | General Hospital of Athens Evangelismos Department of Endocrinology and Diabete | Athens | |
Greece | Hippokration General Hospital Endocrinology and Diabetes Department | Thessaloníki | |
Hungary | Semmelweis Egyetem II. Belgyógyászati Klinika | Budapest | |
Israel | Bnai Zion Medical Center Endocrinology Institute | Haifa | |
Israel | Rabin Medical Center, Beilinson Campus | Petah tikva | |
Israel | Tel Aviv-Sourasky Medical Center Institute Endocrinology Metabolism & Hypertension | Tel Aviv | |
Italy | Clinica Endocrinologia malattie del Metabolismo | Ancona | |
Italy | AOU Policlinico G. Martino Sezione di Endocrinologia | Messina | |
Italy | Via Sergio Pansini 5 Uni Naples FedericoII Dept of Molecular&Clinical Endocrinology&Oncology | Naples | |
Italy | Policlinico Universitario Sant'Andrea | Roma | |
Italy | University of Turin | Turin | |
Netherlands | Erasmus Medical Center | Rotterdam | |
Poland | Instytut Centrum Zdrowia Matki Polki | Lódz | |
Romania | Institutul National de Endocrinologie C.I. Parhon | Cluj-Napoca | |
Romania | Spitalul Clinic Judetean de Urgenta Cluj-Napoca | Cluj-Napoca | |
Romania | Spitalul Clinic Judetean Mures | Târgu-Mures | |
Spain | Hospital Universidad De La Ribera | Alzira | |
Spain | Hospital Universitario Ramón y Cajal | Madrid | |
United States | University of New Mexico HSC - HSC Sponsored Projects Office | Albuquerque | New Mexico |
United States | Emory University | Atlanta | Georgia |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | The Center for Diabetes and Endocrine Care | Fort Lauderdale | Florida |
United States | Columbia University Medical Center | New York | New York |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | Oregon Health & Science University | Portland | Oregon |
United States | Washington University School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Cortendo AB |
United States, Bulgaria, France, Greece, Hungary, Israel, Italy, Netherlands, Poland, Romania, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes from Baseline in 24-h UFC | Changes or shifts from baseline in mUFC | From Baseline to final study visit or up to a maximum of 3 years, whichever comes first. | |
Primary | Changes from Baseline in Late Night Salivary Cortisol | Changes or shifts from baseline in late night salivary cortisol levels | From Baseline to final study visit or up to a maximum of 3 years, whichever comes first. | |
Primary | Changes from Baseline in AEs/SAEs/AESI as assessed by CTCAE V4.03 | Changes from Baseline in the incidence and severity of AEs, SAEs, AESIs | From Baseline to final study visit or up to a maximum of 3 years, whichever comes first. |
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