EUCTR2008-005506-40-AT进行中（未招募）不适用
A double-blind, randomized, vehicle-controlled Proof of Concept (PoC) study, to evaluate the safety, local tolerability, pharmacokinetics and pharmacodynamics of multiple topical administrations of LDE225 (a specific Smoothened inhibitor) on skin basal cell carcinomas in Gorlin syndrome patients followed by an open label, randomized expansion group to test two different strengths of an improved LDE225 formulation for extended treatment durations - LDE225B2203
ovartis Pharma0 个研究点目标入组 15 人开始时间: 2009年6月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patients with multiple basal cell carcinomas and Gorlin’s syndrome fulfilling the diagnostic criteria, or patients suffering from multiple basal cell carcinomas and a mutation in the PTCH1 gene at chromosome 9q22.3, age 18 to 75 years, will be included.
- •2. Patients need to have a minimum of 2 BCCs (scalp, arm, frontal trunk or posterior trunk and legs, no face BCCs ). The basal cell carcinoma(s) should be > 4mm and < 20 mm in diameter.
- •3.Physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study.
- •4.At Screening, and Baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the subject has rested for at least three (3) minutes, and again when required after three (3) minutes in the standing position. Vital signs should be within the following ranges:
- •oral body temperature between 35.0-37.5 °C
- •systolic blood pressure, 90-140 mm Hg
- •diastolic blood pressure, 50-90 mm Hg
- •pulse rate, 40 - 90 bpm
- •If vital signs are out-of-range, the Investigator may obtain two additional readings, so that up to three (3) consecutive assessments are made, each after at least 5 minutes and with the subject seated quietly during the five (5) minutes preceding the assessment. At least the last reading must be within the ranges provided above in order for the subject to qualify.
- •When blood pressure and pulse will be taken again after 3 minutes standing, there shall be no more than a 20 mm Hg drop in systolic or 10 mm Hg drop in diastolic blood pressure and increase in heart rate (>20 bpm) associated with clinical manifestation of postural hypotension.
- •All blood pressure measurements at other time-points should be assessed with the subject seated, unless stated otherwise in the protocol design, and utilizing the same arm for each determination.
- •5.Postmenopausal females must have had no regular menstrual bleeding for at least one (1) year prior to initial dosing. Menopause will be confirmed by a plasma FSH level of >40 IU/L at screening.
- •Female patients who report surgical sterilization must have had the procedure at least six (6) months prior to initial dosing. Surgical sterilization procedures should be supported with clinical documentation made available to the sponsor and noted in the Relevant Medical History / Current Medical Conditions section of the CRF.
- •6.Male patients must be using a two acceptable methods of contraception , (e.g., spermicidal gel plus condom) for the entire duration of the study, up to the Study Completion visit, and refrain from fathering a child in the three (3) (or greater if a long half-life drug) months following the last study drug administration.
- •Periodic abstinence and withdrawal are not acceptable methods of contraception.
- •7.Patients must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 to 29 kg/m2. See Appendix 3 of this protocol for BMI ranges.
- •8.Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
- •Patients who have participated in the first part of the study can participate in Part II if they meet all inclusion/exclusion criteria for Part II. In order to be eligible, new BCC sites need to be identified.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 year
排除标准
- •Patients meeting any of the following criteria will be excluded from entry into or continuation in the study unless sponsor approval is obtained:
- •1.Previous treatment of the BCC’s that are selected for treatment with the study compound (LDE225) or the vehicle.
- •2.Use of any topical treatment whether prescribed or as on OTC on the treated areas during the course of the study.
- •3.Any systemic treatment which is known to affect BCC’s esp. cytostatic treatments, retinoids and photodynamic treatments.
- •4.Treatment with any systemic immunomodulating drugs or systemic retinoid 4 weeks prior to initial dosing.
- •5.Treatment with imiquimod 4 weeks prior to initial dosing.
- •6.Patients who are exposed to UV radiation an/or sun beds within 2 weeks before screening and during treatment.
- •7.Participation in any clinical investigation within 4 weeks prior to initial dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
- •8.A history of keloid scar development.
- •9.Donation or loss of 400 ml or more of blood within eight (8) weeks prior to initial dosing, or longer if required by local regulation.
- •10.Significant illness within two (2) weeks prior to initial dosing.
- •11.A past medical history of clinically significant ECG abnormalities. An abnormal ECG is defined as PR >220 msec, QRS complex >120 msec, QTcB> 440 msec females; QTcB> >430 msec males, or any significant morphological changes, other than non-specific T-wave changes.
- •12.History of multiple and recurring allergies or allergy to the investigational compound/compound class being used in this study.
- •13.Total WBC count which falls outside the range of 4500–11,000/µl, or platelets <100,000/µl at screening.
- •14.History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
- •15.A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- •16.History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening and/or at baseline.
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