NCT04308395终止3 期
A Phase 3, Multicenter, Open-Label Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 107
- 试验地点
- 16
- 主要终点
- Incidence of Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
This is a multicenter, open label extension study evaluating the safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult subjects with Gorlin syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must have completed PellePharm Study Pelle-926-201 or Pelle-926-
- •Study Pelle-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.
- •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.
- •Female subjects must have a negative pregnancy test. 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.
- •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. 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 investigational product (IP).
- •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.
- •The subject is willing for all facial BCCs to be evaluated and follow treatment recommendations made only by the Investigator.
- •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
- •The subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study IP.
- •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 (while enrolled in this study) participation in an experimental drug study (excluding Study 301).
- •The subject is a WOCBP who is unwilling or unable to comply with pregnancy prevention measures.
- •The subject is pregnant or breastfeeding.
研究组 & 干预措施
Patidegib Topical Gel, 2%
Experimental
Patidegib Topical Gel, 2%
干预措施: Patidegib Topical Gel, 2% (Drug)
结局指标
主要结局
Incidence of Treatment-emergent Adverse Events (TEAEs)
时间窗: 12 months
IMP=Investigational medicinal product; Unique adverse event = adverse event of a certain preferred term, counted only once within each subject. Related adverse event = adverse event with relationship as Definitely, Probably or Possibly.
次要结局
- Change in Number of Facial BCCs Removed by Surgery(12 months)
- Change in Number of New Lesions Suspicious for BCC(12 months)
- Change in Advanced Basal Cell Carcinoma Index (aBCCdex) Lesion Score(12 months)
- Change in Dermatology Life Quality Index (DLQI)(12 months)
- Change in EuroQol Group 5-level EQ 5D (EQ 5D 5L)(12 months)
研究者
研究点 (16)
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