A Study: Pure CBD as Single-agent for Solid Tumor.
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 主要终点
- Overall Response Rate according to RECIST 1.1
研究概览
简要总结
Increasing lines of evidence support an antitumourigenic effect of cannabinoids, including the cannabidiol (CBD) which does not posses the psychotropic effects of D9-tetrahydrocannabinol (THC). These include anti-proliferative and pro-apoptotic effects and they are known to interfere with several mechanisms in the tumorgenesis. Yet, evidence from clinical trials among cancer patients is needed. The aim of the current study is to evaluate the impact of CBD as single treatment among cancer patients.
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
- •Confirmed solid cancer
- •Approved license for using cannabis (from the ministry of health: Israel)
- •Progression of all the available standard therapy / unfit to standard therapy according to oncologist's view
- •Measurable disease as determined by RECIST
- •Life expectancy of at least 6 months
- •Eastern Cooperative Oncology Group (ECOG) performance status < or = 2
- •Aged 18 years old and more
排除标准
- •Received cannabis therapy for any indication
- •Previous systemic therapy of less than 3 weeks prior to and, if present, any acute toxicity > grade
- •Clinically significant cardiac disease or any history of psychosis
- •Pregnancy or breast feeding
研究组 & 干预措施
cannabidiol (CBD)
Patients with confirmed solid cancer, after progression of all the available standard therapy or unfit to standard therapy according to oncologist's view, measurable disease as determined by RECIST using CT, life expectancy of at least 6 months, Eastern Cooperative Oncology Group (ECOG) performance status < or = 2 and aged 18 years old and more will be included in the current study.
干预措施: cannabidiol (CBD) (Drug)
结局指标
主要结局
Overall Response Rate according to RECIST 1.1
时间窗: At baseline and at 8 weeks from time of first dose, by CT scans for RECIST 1.1
ORR per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response or partial response (CR+PR) as assessed by investigatorand RECIST criteria.
次要结局
未报告次要终点
研究者
Rotenberg Yakir
Hadas Lemberg, PhD
Hadassah Medical Organization