CTRI/2015/02/005579已完成3 期
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 Cushingâ??s disease
ovartis Healthcare Pvt Ltd0 个研究点目标入组 7 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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 Cushingâ??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.
- •4. Patients with a history of prior pituitary surgery must be at least 30 days post-surgery to be
- •eligible for inclusion in this study.
- •5. Patients that received glucocorticoid replacement therapy post-operatively must have
- •discontinued such therapy for at least one week (5 half-lives) prior to screening.
- •6. Patients with de novo Cushingâ??s disease can be included only if they are not considered
- •candidates for surgery (e.g., poor surgical candidates, surgically unapproachable tumors,
- •patients who refuse to have surgical treatment, or surgical treatment is not available)
- •7. Patients with a history of pituitary irradiation can be included, provided that at least 3 years have elapsed from the time of radiation to the time of enrollment into this study.
- •8. Patients are permitted to washout current drug therapy to meet these entry criteria if they
- •have a known diagnosis of Cushingâ??s disease. The following washout periods must be
- •completed before baseline efficacy assessments are performed:
- •a. Steroidogenesis inhibitors (ketoconazole, metyrapone): 1 week
- •b. Pasireotide s.c. or octreotide s.c. (immediate release formulation): 1 week
- •c. Dopamine agonists (e.g., cabergoline), or PPAR-gamma agonists (e.g., rosiglitazone,
- •pioglitazone): 4 weeks
- •d. Mifepristone or Lanreotide SR: 4 weeks
- •e. Octreotide LAR, Pasireotide LAR and Lanreotide Autogel®: 14 weeks
- •f. Mitotane: 6 months
- •g. Other experimental therapy: at least 5 half-lives or 30 days, whichever is longer
排除标准
- •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 hypersensitivity to LCI699 or to drugs of similar chemical classes.
- •3. 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.
- •4. 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.
- •5. Pregnant or nursing (lactating) women.
- •6. Women of child-bearing potential, defined as all women physiologically capable of
- •becoming pregnant, unless they are using highly effective methods of contraception
- •during dosing and for 1 week after completion of dosing. Highly effective contraception
- •methods include:
- •a. Total abstinence (when this is in line with the preferred and usual lifestyle of the
- •subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation
- •methods) and withdrawal are not acceptable methods of contraception.
- •b. Female sterilization (have had surgical bilateral oophorectomy with or without
- •hysterectomy) or tubal ligation at least six weeks before taking study treatment. In
- •case of oophorectomy alone, only when the reproductive status of the woman has
- •been confirmed by follow up hormone level assessment.
- •c. Male sterilization (at least 6 months prior to screening). For female subjects on the
- •study the vasectomized male partner should be the sole partner for that subject.
- •d. Combination of any two of the following (a+b or a+c, or b+c):
- •a. Use of oral, injected, or implanted hormonal methods of contraception or other
- •forms of hormonal contraception that have comparable efficacy (failure rate less than 1 percent), for example hormone vaginal ring or transdermal hormone contraception
- •b. Placement of an intrauterine device IUD or intrauterine system IUS
- •c. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
- •In the case of use of oral contraception, women should have been stable on the same
- •pill for a minimum of 3 months before taking study treatment.
- •7. Fertile males, defined as all males physiologically capable of conceiving offspring
- •UNLESS they use a condom during intercourse while taking the study medication and for
- •1 week after stopping study medication and should not father a child in this period. A
- •condom is required to be used also by vasectomized men in order to prevent delivery of
- •the drug via seminal fluid.
- •8. Patients with compression of the optic chiasm, in order to exclude patients with a tumor
- •causing chiasmal compression requiring surgery.
- •9. Patients who have a known inherited syndrome as the cause for hormone over secretion
- •(i.e. Carney Comple
研究者
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