NCT03876106已完成1 期
A Phase 1, Open-Label, Dose Escalation Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy Study of Topically Administered LUT014 in Metastatic Colorectal Cancer Patients With EGFR Inhibitor Induced Acneiform Lesions
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 6
- 主要终点
- Safety and tolerability (maximum tolerated dose, MTD) of LUT014 topically applied qd for 4 weeks in metastatic colorectal cancer (mCRC) patients with epidermal growth factor receptor inhibitor (EGFRI) induced acneiform lesions.
研究概览
简要总结
The purpose of this phase 1, multicenter study is to evaluate the safety, tolerability and preliminary efficacy of LUT014 in adult metastatic colorectal cancer patients with EGFR Inhibitor induced acneiform lesions
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Diagnosed with mCRC;
- •Currently being treated with an FDA approved EGFRI for the treatment of mCRC, including but not limited to Erbitux® (cetuximab) Injection and Vectibix® (panitumumab) Injection, as directed by the approved labeling;
- •Treatment with the FDA approved EGFRI initiated within 12 weeks prior to the Screening Visit;
- •Grade 1 or 2 acneiform lesions at the Screening and Baseline (Day 0) Visits; A minimum of 3 subjects per dose cohort must have Grade 2 non-infected acneiform lesions at the Screening and Baseline (Day 0) Visits;
- •Age ≥18 years at the time of signing the informed consent form (ICF);
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2;
- •Expected life expectancy greater than 3 months;
- •Subject can understand and sign the ICF, can communicate with the Investigator, can understand and comply with the requirements of the protocol, and can apply the study drug by himself/herself or has a care giver that can apply the drug;
- •Women of childbearing potential (WCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at baseline (Day 0);
- •WCBP must agree to abstain from sex or use an adequate method of contraception from the time of informed consent through the Day 55 Visit and for 90 days after the last dose of study drug (LUT014);
- •Males must abstain from sex with WCBP or use an adequate method of contraception from the time of informed consent through the Day 55 Visit and for 90 days after the last dose of study drug (LUT014).
排除标准
- •Active infection;
- •Significant skin disease other than EGFRI induced acneiform lesions;
- •Any cancer other than mCRC within 3 years of Screening;
- •Any condition which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study;
- •Clinically relevant serious co-morbid medical conditions including, but not limited to, unstable angina, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias, chronic obstructive or chronic restrictive pulmonary disease, active central nervous system (CNS) disease uncontrolled by standard of care, known positive status for human immunodeficiency virus (HIV) and/or active hepatitis B or C, cirrhosis, or psychiatric illness/social situations that would limit compliance with study requirements;
- •Pregnant or lactating;
- •Treatment with an EGFRI other than those specified in the inclusion criteria within 30 days or 5 half-lives of the drug prior to Screening, whichever is longer;
- •Treatment with a serine/threonine-protein kinase B-Raf (B-Raf) inhibitor, including but not limited to Zelboraf® (vemurafenib), Tafinlar® (dabrafenib), BraftoviTM (encorafenib), and Nexavar® (sorafenib), within 30 days or 5 half-lives of the drug prior to Screening, whichever is longer;
- •Treatment with a systemic antibiotic within 7 days prior to Screening;
- •Treatment with a topical corticosteroid to the face, neck, or upper portion of the anterior or posterior chest within 14 days prior to Screening or treatment with a systemic corticosteroid within 14 days prior to Screening, except for low dose systemic corticosteroids (e.g., 8-20 mg dexamethasone or comparable) given for up to one or two days every two weeks as part of standard of care for the prevention or treatment of chemotherapy-induced nausea and vomiting (CINV) for subjects being treated with FDA-approved EGFRI and chemotherapy combinations for mCRC;
- •Treatment with an oral retinoid within 7 days prior to Screening;
- •Treatment with another investigational drug within 30 days or 5 half-lives of drug prior to Screening, whichever is longer;
- •Known hypersensitivity to the inactive ingredients of the study drug (LUT014).
研究组 & 干预措施
LUT014 dose level 1
Experimental
LUT014 will be topically applied to the face, neck, and upper portion of the anterior and posterior chest once a day for 4 weeks.
干预措施: LUT014 (Drug)
LUT014 dose level 2
Experimental
LUT014 will be topically applied to the face, neck, and upper portion of the anterior and posterior chest once a day for 4 weeks.
干预措施: LUT014 (Drug)
LUT014 dose level 3
Experimental
LUT014 will be topically applied to the face, neck, and upper portion of the anterior and posterior chest once a day for 4 weeks.
干预措施: LUT014 (Drug)
结局指标
主要结局
Safety and tolerability (maximum tolerated dose, MTD) of LUT014 topically applied qd for 4 weeks in metastatic colorectal cancer (mCRC) patients with epidermal growth factor receptor inhibitor (EGFRI) induced acneiform lesions.
时间窗: From Day 0 (following administration of the first dose of study drug) through the Day 55
次要结局
- Area under the concentration-time cure from time zero extrapolated to infinity (AUC0-∞)(Pre-dose through Day 8)
- Maximum concentration (Cmax) in plasma after a single administration and after qd administrations for 8 days(Pre-dose through Day 8)
- Time to maximum concentration (Tmax) in plasma after a single administration and after qd administrations for 8 days(Pre-dose through Day 8)
- Area under the concentration-time curve from time zero to last measurable concentration (AUC0-T)(Pre-dose through Day 8)
- Plasma clearance (CL)(Pre-dose through Day 8)
- Volume of distribution (Vd)(Pre-dose through Day 8)
- Plasma elimination half-life (t1/2)(Pre-dose through Day 8)
- NCI, Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 skin and subcutaneous tissue disorders grading scale performed locally by the Investigator(Pre-dose through Day 55)
- MASCC Study Group EGFRI-dermatologic AE grading by central reader based on photographs(Pre-dose through Day 55)
- Functional Assessment of Cancer Therapy-EGFRI 18 (FACT-EGFRI-18) on health-related quality of life (HRQoL) questionnaire(Pre-dose through Day 55)
研究者
研究点 (6)
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