Phase I-II study on the safety and effectiveness of gel for external application of DRIPs inhibitors in the treatment of non-melanoma skin cancer

Phase 1

Recruiting

• Conditions: Basal cell carcinoma; Bowen’s disease; Actinic keratosis; Squamous cell carcinoma of the skin; Cancer - Non melanoma skin cancer; Skin - Dermatological conditions

• Registration Number: ACTRN12623001219673
• Lead Sponsor: EnKang Pharmaceuticals (Australia) Pty Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-27
• Last Update Posted: 4 December 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified