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|NCT02180217 : Safety and Efficacy of LCI699 for the Treatment of Patients With Cushing's Disease|
|Ages||Min: 18 Years Max: N/A|
- Written informed consent must be obtained before any assessment is performed.
- Male or female patients aged 18-75 years
- Patients must have confirmed Cushing's disease that is persistent or recurrent as
1. mUFC> 1.5 x ULN (mean of three 24-hour urine samples collected within 14 days)
2. morning plasma ACTH above lower limit of normal
3. confirmation of pituitary source of excess ACTH is defined by any of the
following three criteria: (1) MRI confirmation of pituitary adenoma > 6 mm; OR
(2) bilateral inferior petrosal sinus sampling (BIPSS) with either CRH or DDAVP
stimulation for patients with a tumor = 6mm. The criteria for a confirmatory
BIPSS test are any of the following: - pre-dose central to peripheral ACTH
gradient > 2; -post-dose central to peripheral ACTH gradient > 3 after either
CRH or DDAVP stimulation; OR (3) histopathologic confirmation of an
ACTH-staining adenoma in patients who have had prior pituitary surgery.
- Patients with a history of prior pituitary surgery must be at least 30 days
post-surgery to be eligible for inclusion in this study.
- Use of other investigational durgs at the time of enrollment, or within 30 days or 5
half-lives at the time of enrollment, whichever is longer; or longer if required by
local regulations, and for any other limitation of participation in an
investigational trial based on local regulations.
- history of hypersensitivity to LCI699 or to drugs of similar chemical classes.
- hisotry of malignancy of any organ system (other than localized basal cell carcinoma
of the skin), treated or untreated, within the past 5 years, regardless of whether
there is evidence of local recurrence or metasteses.
- patients with risk factors for QTc prolongation or Torsade de Pointes, including:
patients with a baseline QTcF > 470ms, personal or famiily history of long QT
syndrome, or concomitant medications known to prolong the QT interval, hypokalemia,
hypocalcaemia, or hypomagnesemia.
- Pregnant or nursing (lactating) women.
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