ACTRN12620001200976尚未招募未知
Sonidegib (Odomzo) neo-adjuvant therapy for participants with Gorlin syndrome – A pilot study
Samson Clinical Pty Ltd0 个研究点目标入组 6 人开始时间: 2020年11月12日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1) Males and females participants aged 18 years and above at Screening visit
- •2) Clinical diagnosis of Gorlin syndrome (Basal Cell Nevus Syndrome). Participants must satisfy the established criteria for diagnosis of Gorlin Syndrome
- •3) All target lesions (12 lesions) must be biopsied prior to successful enrolment into the study.
- •4) Participants must not require immediate surgical removal of lesions, or commence radiotherapy
- •5) No recent treatment for BCCs in the last 4 weeks prior to first dose of study medication
- •6) Female participants have to be either infertile (WONCBP), not pregnant, lactating, postmenopausal, surgically sterile or using acceptable and highly effective birth control methods.
- •7) Are willing to comply with all study requirements (primary and secondary treatment phases) including excision, cryotherapy and daily topical treatment of specific lesions.
- •8) Ability to comprehend and willing to sign and date an informed consent form (ICF).
排除标准
- •1) Have not met the Clinical diagnosis of Gorlin syndrome (Basal Cell Nevus Syndrome). Participants must satisfy the established criteria for diagnosis of Gorlin Syndrome.
- •2) Insufficient number of BCCs (minimum of 12 lesions)
- •3) Target tumor biopsy shows evidence of micronodular features, squamous metaplasia, sclerosing BCC, morpheic BCC, or peri-neural involvement
- •4) Participants receiving medications that are recognized to cause rhabdomyolysis or participants with a prior history of rhabdomyolysis
- •5) previous use of topical treatment to treat BCCs in the 4 weeks prior to first dose of study drug
- •6) previous use of photodynamic therapy (PDT), radiation or systemic treatment known to affect BCCs or neoplasm in the 12 weeks prior to first dose of study drug
- •7) Participants requiring immediate surgical removal of lesions or other related emergency interventions
- •8) Immunocompromised (e.g. known Hepatitis B or C infection, HIV infection) or is receiving or is expected to receive an immunomodulating agent (including immunosuppressive agents, cytotoxic drugs, biological agents, immunoglobulins, interferon or other immune or cytokine-based therapies.
- •9) Eastern Cooperative Oncology Group (ECOG) performance status > 1.
- •10) Known or suspected metastatic disease.
- •11) Clinically active or uncontrolled skin disease that would interfere with evaluation of the area surrounding the target tumour (e.g. eczema, unstable psoriasis)
- •12) Any experimental or investigational agents within 6 weeks of first dose of study drug
- •13) Female participants who are pregnant, planning a pregnancy or nursing a child or not on an acceptable and highly effective birth control method.
- •14) Female participants who are of child-bearing potential (WOCBP) who are not on 2 methods of contraception (1 highly effective method and 1 barrier method)
- •15) Any clinically significant abnormal laboratory values as determined by the Principal Investigator.
- •16) Unwilling to comply with all study procedures and assessments
研究者
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