An Open-label, Rollover Study of Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib Study
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 16
- 主要终点
- Number of participants with serious adverse events, treatment-related adverse events, and any AEs leading to treatment discontinuation graded according to NCI-CTCAE v5.0.
研究概览
简要总结
This is a nonrandomized, open-label, multicenter rollover study for patients who received futibatinib as monotherapy or as combination therapy in a Taiho-sponsored futibatinib study.
详细描述
TAS-120-404 is a nonrandomized, open-label, multicenter rollover study for patients who received futibatinib as monotherapy or as combination therapy in a Taiho-sponsored futibatinib study.
Patients who are still receiving futibatinib as monotherapy or as combination therapy, are deriving clinical benefit with no undue risk as assessed by the investigator, and have not met any of the antecedent protocol-specific discontinuation criteria are eligible to participate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Provide written informed consent.
- •Receiving futibatinib as monotherapy or as combination therapy in an antecedent futibatinib study and deriving clinical benefit with no undue risk as assessed by the investigator.
- •Women of childbearing potential (WOCBP) must have a negative pregnancy test (urine or serum) within 7 days prior to receiving treatment. Both males and females of reproductive potential must agree to use effective birth control during study treatment and for a specified time after the last dose of study treatment.
- •Ability to take medications orally (PO) (feeding tube is not permitted).
排除标准
- •Has met any discontinuation criteria within the antecedent futibatinib study.
研究组 & 干预措施
TAS-120 (futibatinib) combination therapy with fulvestrant
TAS-120 tablets in combination with fulvestrant, oral, cycle length is defined as per antecedent study design
干预措施: futibatinib, fulvestrant (Drug)
TAS-120 (futibatinib) monotherapy
TAS-120 tablets, oral, cycle length is defined as per antecedent study design
干预措施: futibatinib (Drug)
结局指标
主要结局
Number of participants with serious adverse events, treatment-related adverse events, and any AEs leading to treatment discontinuation graded according to NCI-CTCAE v5.0.
时间窗: through study completion, an average of 5 years
To collect long term safety information in patients continuing to receive treatment with futibatinib as monotherapy or in combination with fulvestrant who participated in a Taiho-sponsored futibatinib study and who are deriving clinical benefit with no undue risk
次要结局
未报告次要终点