Join the Research Effort forendogenous cushing’s syndrome
What Is LOGICS?
- LOGICS is a global, phase 3, double-blind, placebo-controlled, randomized withdrawal following open‑label therapy study to assess the safety and effectiveness of levoketoconazole (2S, 4R-ketoconazole) for endogenous Cushing’s syndrome.
- The study is being conducted in more than 11 countries in North America, Europe, and the Middle East.
Could your patients be eligible for the study?
The LOGICS study is now recruiting subjects to enroll approximately 54 subjects in the randomized withdrawal phase of the study. Subjects who are over the age of 18 and have a confirmed newly diagnosed, persistent, or recurrent endogenous Cushing’s syndrome (CS) and are not candidates for surgery or radiotherapy may be eligible.
To be eligible for enrollment in this study, a subject must meet these and other inclusion criteria (please visit www.clinicaltrials.gov for key eligibility criteria):
- Male or female and at least 18 years of age.
- Confirmed newly diagnosed, persistent or recurrent endogenous CS of any etiology, except secondary to malignancy (including pituitary or adrenal carcinoma). Persistence will not be considered confirmed until 6 weeks or more post-surgery.
- Elevated mean 24 hour UFC levels at least 1.5X ULN of the normative range of the study’s central laboratory assay and from a minimum of three measurements from adequately collected urine.
- Presence of abnormal values from at least one of these two diagnostic tests:
- Abnormal Dexamethasone Suppression Test (DST): Elevated 8 AM serum cortisol at least 1.8 µg/dL (50 nmol/L) after 1 mg dexamethasone orally at 11 PM the evening prior with concurrent dexamethasone blood concentration greater than 5.6 nmol/liter (2.20 ng/dL) (results from within the 2 months prior to start of Screening or newly tested with results available by the Baseline Visit [TM0]) OR
- Elevated LNSC concentrations (at least two measurements) each greater than the ULN of the study’s central laboratory normative range.
NOTE: Abnormal LNSC is required among eligible subjects with estimated glomerular filtration rate (eGFR as determined by Modified Diet in Renal Disease MDRD equation) above 40 and below 60 mL/min/1.73 m2.
- Non-candidates for CS-specific surgery, refuse surgery or surgery will be delayed until after study completion and agree to complete this study prior to surgery.
- If post-surgical for CS-specific surgery, then no significant post-operative sequelae remain and the risk of such sequelae is considered negligible.
Patients with any of the following conditions are excluded from this study (please visit www.clinicaltrials.gov for key eligibility criteria):
- Pseudo-Cushing’s syndrome based on assessment of the investigator.
- Cyclic Cushing’s syndrome with multi-week periods of apparent spontaneous CS remission.
- Non-endogenous source of hypercortisolism, including pharmacological corticosteroids or ACTH.
- Radiotherapy of any modality directed against the source of hypercortisolism within the last 5 years.
- Treatment with mitotane within 6 months of 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).