NCT05580172招募中1 期
A Phase 1 Open Label Dose Ranging Study of Oral RH324 in Advanced Non-Small Cell Lung Cancer
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events Version 5
研究概览
简要总结
Phase 1 open label dose ranging study of RH324 in advanced non-small cell lung cancer
详细描述
This is a Phase 1 open label dose ranging study to assess the safety and tolerability of oral RH324 in advanced non-small cell lung cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 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
- •Advanced Non-Small Cell Lung Cancer
- •Measurable Target Lesion by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- •Failed all standard of care including chemotherapy, targeted therapy, and immunotherapy
- •Adults over 18 years
- •Performance status (Eastern Cooperative Oncology Group) less than or equal to 2
- •Life expectancy greater than 2 months
- •Laboratory Values:
- •Hemoglobin greater than or equal to 9; neutrophils greater than 1,000; platelets greater than 50,000 Liver function tests less than or equal to twice upper limit of normal Serum Creatinine less than or equal to 2 Creatinine clearance greater than or equal to 30 mL per minute Hemoglobin A1C less than 7 Normal Thyroid function
- •No history of hyperthyroidism
- •Abstinence from alcohol and supplements
- •Not pregnant, lactating and willing to use birth control throughout study
- •Able to provide consent
- •Positive Emission Tomography/Computer Tomography part of subjects care plan at baseline
排除标准
- •Prior use of Withania somnifera
- •Phenylketonuria
- •Inability to swallow capsules
- •Hypersensitivity to study drug ingredients
- •Unstable medical or surgical condition
- •History of additional cardiac risk factors
- •Requiring drugs that are "strong" inhibitors of cytochrome P450
- •Requiring irradiation
- •Requiring intravenous fluids or hyperalimentation
- •Requiring transfusions, dialysis, or other procedures
- •Active infection
- •Human Immunodeficiency Virus
- •Must exceed washout period of prior treatments
- •Psychiatric, neurological or other reason that precludes subjects ability to participate
研究组 & 干预措施
Dose Level 1
Experimental
RH324
干预措施: RH324 (Drug)
Dose Level 2
Experimental
RH324
干预措施: RH324 (Drug)
Dose Level 3
Experimental
RH324
干预措施: RH324 (Drug)
结局指标
主要结局
Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events Version 5
时间窗: Through Study Completion 28 Days
Percentage of Adverse Events Summarized by Causality and Grade
次要结局
- Percentage of Subjects with a Change from Baseline on the Electrocardiogram(Through Study Completion 28 Days)
- Percentage of Subjects with a Change from Baseline on Laboratory Values(Through Study Completion 28 Days)
- Percentage of Subjects with a Change from Baseline in Quality of Life(Through Study Completion 28 Days)
- Percentage of Subjects with a Change from Baseline on Physical Examination and Vital Signs(Through Study Completion 28 Days)
研究者
研究点 (1)
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