NL-OMON49176已完成3 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
- 3 期
- 状态
- 已完成
- 入组人数
- 10
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
- 年龄范围
- 18 至 99（—）
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.
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
- •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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