EUCTR2009-013665-26-AT进行中（未招募）不适用
A double-blind, randomized, vehicle-controlled Proof of Concept (PoC) study to evaluate the efficacy, safety, local tolerability, pharmacokinetics and pharmacodynamics of multiple topical administrations of LDE225 (a specific Smoothened inhibitor) on sporadic superficial skin basal cell carcinomas
ovartis Pharma0 个研究点目标入组 48 人开始时间: 2009年12月9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
- 48
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. Male and female (non-childbearing potential) patients, ages 18 to 75 years (inclusive), with one histologically confirmed superficial or nodular basal cell carcinoma (diameter 8-20 mm), eligible for surgical excision on selected body areas (scalp, arm, frontal trunk, posterior trunk, upper legs), will be included. (Note: Presence of other non-melanoma skin cancers at sites distant from the qualifying sBCC will not a priori exclude the patient from the study).
- •2. Physical examination must be without significant disease findings (other than sBCC or nBCC) unless the Investigator considers an abnormality to be irrelevant to the outcome of the study.
- •3. At Screening, Visit 1, 15 and Safety Visit, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the supine position after the patient 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, 90-150 mm Hg
- •diastolic blood pressure, 50-95 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 patient 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 patient 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 patient seated, unless stated otherwise in the protocol design, and utilizing the same arm for each determination.
- •4. 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 (tubal ligation is not considered adequate) 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.
- •5. Male patients must be using two highly effective methods of contraception (comprising a barrier method such as condom or occlusive cap plus spermicide) plus ensure use by the female partner of a second method of contraception. These measures should be in place for the entire duration of the study to the Study Completion visit, males should refrain from fathering a child in the three (3) months following the last study drug administration. Periodic abstinence and withdrawal are not acceptable methods of contraception.
- •6. 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.
- •7. Able to communicate well with the Investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age ra
排除标准
- •Patients meeting any of the following criteria will be excluded from entry into or continuation in the study.
- •1. Previous treatment of the BCC that is selected for treatment.
- •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 BCCs especially 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 within 4 weeks prior to initial dosing.
- •6. Women of child-bearing potential; nursing or pregnant women.
- •7. Dark-skinned persons whose skin color prevents readily assessment of skin reactions (patients with skin phototype IV or higher (Fitzpatrick classification of Skin Phototypes (I-VI) (Pathak and Fitzpatrick 1993) will be excluded.
- •8. Use of any prescription drugs, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing. If needed, (i.e. an incidental and limited need) paracetamol is acceptable, but must be documented in the Concomitant medications / Significant non-drug therapies page of the CRF.
- •9. Use of any topical creams or lotions on the treated area during the course of the study.
- •10. A history of, or suffering from, any skin condition in the area of application.
- •11. Tattoos, scars or excess hair in the area of application that will prevent skin assessment.
- •12. A history of keloid scars.
- •13. Participation in any clinical investigation within four (4) weeks prior to initial dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
- •14. 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.
- •15. Significant illness within two (2) weeks prior to initial dosing.
- •16. A past medical history of clinically significant ECG abnormalities.
- •17. An abnormal ECG (defined as PR > 220 msec, QRS complex > 120 msec,
- •QTcB > 430 msec females; QTcB > 420 msec males, or any significant morphological
- •changes, other than non-specific T-wave changes).
- •18. Recent (within the last three [3] years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc).
- •19. History of multiple and recurring allergies or allergy to the investigational
- •compound/compound class being used in this study.
- •20. Laboratory safety tests outside the reference range and deemed clinically significant.
- •21. History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
- •22. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- •23. 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.
- •24. Total WBC count which falls outside the range of 4000–10,000/µL, or platelets
- •<150,000/µL at screening.
- •25. Patients who are exposed to UV radiation and/or tanning beds within 2 weeks before screening and during treatment.
- •26. Patients with history of allergy or intolerance to local anesthetics and or epinephrine to be used for skin surgical procedures.
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