UNIQUE: Umbrella N-of-1 Tumor Trials - Umbrella Protocol for Oncology Single Patient Protocols
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Overall response rate for the overall cohorts and the number of patients accessing precision targeted therapy
研究概览
简要总结
The purpose of this study is to collect data for assessing the improvement of the overall response rate for the overall cohorts and the proportion of patients accessing precision targeted therapy.
详细描述
The UNIQUE umbrella protocol is an overarching framework to study precision medicine in patients with precise molecular data, who have exhausted all established treatment options and who are not eligible for any of the ongoing trials. Participants who have received/who may receive the following treatments may join the study and will be assigned to a study cohort (group):
- Group 1 - Health Canada approved/marketed drug(s) used on or off-label as per Standard of Care (SOC)
- Group 2 - Drugs accessed from Special Access Program (SAP)
- Group 3 - Non-marketed investigational agents
Under the UNIQUE framework, data from participants will be evaluated. The following data will be collected:
- Demographic data (for example: sex, race, month and year of birth)
- Medical history
- Cancer characteristics including biomarkers
- Treatment history
- response to treatment
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- 未提供
排除标准
- •Patient's existing genomic information from tumor molecular profiling will be discussed in the hospital expert molecular tumor board rounds consisting of representatives from specialist genomic profiling and medical oncology departments to decide N of 1 treatment for the patient. The discussion will surround the best next therapeutic option in the patient's cancer subtype with or without clear standard of care guidelines. Therefore, specific eligibility criteria aside from individual patient's medical history is not applicable.
结局指标
主要结局
Overall response rate for the overall cohorts and the number of patients accessing precision targeted therapy
时间窗: 3 years
次要结局
- Overall survival rate(5 years)
- Progression-free survival(5 years)
- Number of participants with adverse events as assessed by CTCAE v5.0(3 years)