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About
This is a long-term, open-label extension study of levoketoconazole in subjects with endogenous Cushing's Syndrome.
Full 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.
Enrollment
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Inclusion criteria
Completed the Extended Evaluation Phase of Study COR-2012-01 (i.e. M12)
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:
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
Primary purpose
Allocation
Interventional model
Masking
51 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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