ACTRN12623001219673招募中1 期
A phase I-II clinical trial to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of EN002-gel in patients with non-melanoma skin cancer and precancerous lesions
EnKang Pharmaceuticals (Australia) Pty Ltd.0 个研究点目标入组 95 人开始时间: 2023年11月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 95
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
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •All enrolled subjects should meet the following criteria:
- •(1)Able to sign the informed consent form freely and voluntarily, finish the follow-ups and complete the study assignments;
- •(2)Aged greater than or equal to 18 years old;
- •(3)Study subjects should be (one or more of the following):
- •diagnosed with AK by histopathological examination or non-invasive diagnosis (dermoscopy, skin CT, etc.);
- •diagnosed with Bowen's disease by histopathological examination;
- •diagnosed with primary basal cell carcinoma of the skin (including nodular, superficial, micronodular and other histopathological types with low risk of recurrence) by histopathological examination;
- •diagnosed with primary squamous cell carcinoma of the skin by histopathological examination;
- •(4) The total lesion area of the whole body is not more than 25 cm²;
- •(5)Not suitable for surgical or radiotherapy treatment at the affected area, or unwilling to accept surgical or radiotherapy treatment;
- •(6)Major organs’ functions meet the following criteria:
- •·Hematology: neutrophil greater than or equal to 1.5×109 /L, platelets greater than or equal to 50×109 /L, hemoglobin greater than or equal to 9.0 g/dL;
- •·Liver function: total bilirubin less than or equal to 1.5 x ULN, except for those with Gilbert syndrome; ALT/AST less than or equal to 2.5 x ULN in the absence of liver metastases;
- •·Coagulation: international normalized ratio (INR) less than or equal to 1.5 x ULN and activated partial thromboplastin time (APTT) less than or equal to 1.5 x ULN (INR and APTT are within the safe and effective therapeutic range as judged by the investigator for those on anticoagulation);
- •·Renal function: serum creatinine less than or equal to 1.5 x ULN, or creatinine clearance greater than or equal to 60 mL/min/1.73 m2 (for those with creatinine > ULN); urine protein less than or equal to 1+ (if greater than or equal to 2+, 24 h urine protein test is required; if 24 h urine protein < 1 g, enrollment is allowed);
- •·Cardiac function: Left ventricular ejection fraction (LVEF) > 50% by echocardiography (ECHO) or multi-gated acquisition (MUGA);
- •(7)Men and women of childbearing potential must agree to take effective contraception measures from the time they sign the informed consent form until 3 months after the last dose of the investigational drug; women of childbearing potential must have a negative clinical pregnancy test result within 7 d prior to the first dose of the investigational drug; and postmenopausal women must be amenorrheic for at least 12 months before they are considered infertile.
排除标准
- •Subjects have any of the following conditions should not be enrolled:
- •(1)Subjects with known serious hypersensitivity or serious adverse reactions to the investigational drug, or with an allergic constitution;
- •(2)Life expectancy is estimated to be less than 12 weeks;
- •(3)Subjects who have used other topical treatments (e.g., fluorouracil ointment, Imiquimod cream, photodynamic therapy) within 7 d prior to the first dose;
- •(4)Subjects who have received targeted therapy, chemotherapy, immunotherapy and other systemic anticancer therapy within 4 weeks prior to enrollment;
- •(5)Subjects with ulcerate/damaged skin within 5 cm of the target lesion;
- •(6)Subjects with lymph node metastasis or important organ metastasis of tumors by imaging examination;
- •(7)Subjects with neurological/psychiatric, respiratory, cardiovascular, digestive, hematological and lymphatic, endocrine, skeletal-muscular, or any other disorders or physiological conditions that may impair the results of the study;
- •(8)Subjects with positive antibodies to human immunodeficiency virus (HIV); positive hepatitis B surface antigen (HBsAg) and HBV-DNA greater than or equal to the lower limit of quantification; positive antibodies to hepatitis C virus (HCV) and HCV-RNA greater than or equal to the lower limit of quantitation; or positive treponema pallidum antibodies;
- •(9)Pregnant or lactating women, or subjects with a planned pregnancy within 3 months;
- •(10)Subjects who have participated in any other clinical trial within 3 months prior to this study;
- •(11)Other conditions judged by the investigator to be ineligible for the study.
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