EUCTR2020-000253-27-DK进行中（未招募）1 期
A Phase 3, Multicenter, Open-Label Extension Study of Patidegib Topical Gel, 2% in Subjects with Gorlin Syndrome (Basal Cell Nevus Syndrome) - PATIDEGIB Phase 3 OLE study in subjects with Gorlin syndrome
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
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. The subject must be at least 18 years old.
- •2. The subject must provide written informed consent prior to any study procedures.
- •3. The subject must have completed PellePharm Study 926-201 or 926-301 with adequate compliance
- •4. Study 926-301 subjects must have completed the End of Treatment Visit in Study 301, prior to the Screening Visit in this study. They must also complete all Study 301 related procedures prior to the Baseline Visit of this study.
- •5. The subject must meet diagnostic criteria for Gorlin (basal cell nevus) syndrome, including major criterion #a plus 1 additional major criterion or plus 2 additional minor criteria listed in Appendix 17.2
- •6. The subject must be willing to abstain from application of a non-study topical medication (prescription or over the counter) to facial skin for the duration of the trial except as prescribed by the Investigator. Moisturizers and emollients are allowed. Subjects will be encouraged to use their preferred sunscreen with a sunscreen protection factor (SPF) of at least 30 daily on all exposed skin sites.
- •7. Female subjects must have a negative pregnancy test (serum pregnancy test at Screening Visit, urine pregnancy test at Baseline Visit). For Study 301 subjects, a negative serum pregnancy test result from Study 301 is acceptable if the test was done within 7 days of the Screening Visit of this study.
- •8. If the subject is a woman of child bearing potential (WOCBP), she must be willing to use birth control methods which may be considered highly effective (Appendix 17.1). Hormonal contraception must be supplemented with a barrier method (preferably condom). Birth control must start prior to Baseline, continue through the duration of the study, and for 30 days after last application of IP
- •9. If the subject is a male with a female sex partner who is a WOCBP, the subject must be willing to use condoms, even after a vasectomy, starting prior to Baseline, through the duration of the study, and for at least 3 months after the last application of IP.
- •10. The subject is willing for all facial BCCs to be evaluated and follow treatment recommendations made only by the Investigator
- •11. The subject is willing to forego treatment of facial BCCs with anything other than the study IP except when the Investigator believes that delay of treatment of a BCC potentially might compromise the health of the subject. In such instances, the only other allowed form of treatment is surgical.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. The subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study IP. Among these are use of the following:
- •a. 5-fluorouracil, imiquimod, or Ingenol mebutate (except as topical treatment to anatomical areas other than the face) systemically or topically to the skin within the 2 months prior to the Screening and Baseline Visit.
- •b. Systemic chemotherapy within 1 year prior to the Screening and Baseline Visit.
- •c. Known inhibitors of the Hedgehog signaling pathway (e.g., vismodegib, sonidegib, itraconazole) topically (except as topical treatment to anatomical
- •areas other than the face) or systemically within 2 months prior to the Screening and Baseline Visit.
- •d. Photodynamic therapy (PDT) except to localized non-facial, individual BCCs within 2 months prior to the Screening and Baseline Visit.
- •2. The subject has a known hypersensitivity to any of the ingredients in the study IP formulation.
- •3. The subject is unable or unwilling to make a good faith effort to return to the study site for all study visits and tests.
- •4. The subject has current, recent (within five half lives of the experimental drug or if half life not known, within the past 6 months prior to the Screening Visit), or planned participation in an experimental drug study (excluding Study 926-301) while enrolled in this study.
- •5. The subject is a WOCBP who is unwilling or unable to comply with pregnancy prevention measures.
- •6. The subject is pregnant or breastfeeding.
- •7. The subject has any condition or situation which, in the Investigator’s opinion, may put the subject at significant risk, could confound the study results, or could interfere significantly with the subject’s participation in the study. This may include a history of other skin conditions (e.g., severe facial eczema) or diseases, metabolic dysfunction, physical examination (PE) findings, or clinical laboratory findings giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk from treatment complications.
研究者
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