A Phase III, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing’s disease

OVARTIS FARMA S.p.A.0 个研究点目标入组 137 人开始时间: 2014年6月13日最近更新: 2021年8月17日

适应症

试验速览

暂无简介。

•1. Written informed consent must be obtained before any assessment is performed.
•2. Male or female patients aged 18 - 75 years
•3. Patients must have confirmed Cushing’s Disease that is persistent or recurrent as evidenced by:
•a. mUFC > 1.5 x ULN (Mean of three 24-hour urine samples collected within 14 days)
•b. Morning plasma ACTH above lower limit of normal
•c. 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.
•Additional inclusion criteria as per full protocol may apply.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 119
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 13

•1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 halflives 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.
•2. History 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 metastases.
•3. Patients with risk factors for QTc prolongation or Torsade de Pointes, including: patients with a baseline QTcF > 470ms, personal or family history of long QT syndrome, or concomitant medications known to prolong the QT interval, hypokalemia, hypocalcaemia, or hypomagnesemia.
•4. Pregnant or nursing (lactating) women.
•Additional exclusion criteria as per full protocol may apply.

发起方

OVARTIS FARMA S.p.A.