A Multicenter, Open-label Rollover Study of Sitravatinib Alone or in Combination With Other Anticancer Therapies in Patients With Advanced or Metastatic Solid Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 20
- 主要终点
- Number of Participants With Treatment Related Adverse Events.
研究概览
简要总结
A Study of Sitravatinib Alone or in Combination with Other Anticancer Therapies in Advanced or Metastatic Malignancies
详细描述
Sitravatinib is a spectrum-selective receptor tyrosine kinase (RTK) inhibitor that inhibits several closely related RTKs including the TAM family (Tyro3/Axl/MERTK), VEGFR2, KIT, and MET.
The current study is designed to allow continued access to sitravatinib and to evaluate the safety and tolerability of sitravatinib alone or in combination with other anticancer therapies in patients who are deriving clinical benefit in a previous parent clinical trial.
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
- •Currently receiving sitravatinib single- agent or in combination with other therapeutic agent(s) in another Mirati- sponsored protocol
- •Currently tolerating the treatment regimen in the parent protocol
- •Experiencing clinical benefit with or without prior radiographic progression from the treatment regimen in the parent protocol in the opinion of the investigator and the investigator determines that continuing treatment is in the patient's best interest
排除标准
- •Known or suspected presence of other cancer
- •Other life- threatening illness or organ system dysfunction compromising safety evaluation
研究组 & 干预措施
Phase 2/3: Open label extension of parent study
The current study is designed to allow continued access to sitravatinib and to evaluate the safety and tolerability of sitravatinib alone or in combination with other anticancer therapies in patients who are deriving clinical benefit in a previous parent clinical trial.
干预措施: Enfortumab Vedotin-Ejfv (Drug)
Phase 2/3: Open label extension of parent study
The current study is designed to allow continued access to sitravatinib and to evaluate the safety and tolerability of sitravatinib alone or in combination with other anticancer therapies in patients who are deriving clinical benefit in a previous parent clinical trial.
干预措施: Ipilimumab (Drug)
Phase 2/3: Open label extension of parent study
The current study is designed to allow continued access to sitravatinib and to evaluate the safety and tolerability of sitravatinib alone or in combination with other anticancer therapies in patients who are deriving clinical benefit in a previous parent clinical trial.
干预措施: Nivolumab (Drug)
Phase 2/3: Open label extension of parent study
The current study is designed to allow continued access to sitravatinib and to evaluate the safety and tolerability of sitravatinib alone or in combination with other anticancer therapies in patients who are deriving clinical benefit in a previous parent clinical trial.
干预措施: Pembrolizumab (Drug)
Phase 2/3: Open label extension of parent study
The current study is designed to allow continued access to sitravatinib and to evaluate the safety and tolerability of sitravatinib alone or in combination with other anticancer therapies in patients who are deriving clinical benefit in a previous parent clinical trial.
干预措施: Sitravatinib (Drug)
结局指标
主要结局
Number of Participants With Treatment Related Adverse Events.
时间窗: Approximately up to 80.5 weeks
An AE is any reaction, side effect or other undesirable medical event that occurs during participation in a clinical trial, regardless of treatment group or suspected causal relationship to study treatment. Assessment of AEs will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE, Version 5.0\]), timing, seriousness, and relatedness to study treatment. A treatment-emergent AE (TEAE) is an AE that occurs after the first dose of any study treatment or any pre-existing condition that increases in severity after the first dose of study treatment.
Number of Participants With Treatment Related Adverse Events Which Lead to Study Drug Discontinuation
时间窗: Approximately up to 80.5 weeks
Number of participants with treatment related adverse events which lead to study drug discontinuation.
Number of Participants With Clinically Significant Laboratory Abnormalities
时间窗: Approximately up to 80.5 weeks
An abnormal laboratory test result should be reported as an AE in the CRF only if it is associated with one or more of the following: * Clinical symptoms; * Requires additional tests (beyond repeats), treatment, or intervention; * Results in change in study treatment dosing; * Requires discontinuation from study treatment; and/or * Considered by the investigator or sponsor to be an AE.
次要结局
未报告次要终点