Ivosidenib in Locally Advanced or Metastatic Cholangiocarcinoma With IDH1 R132 Mutation After at Least One Prior Systemic Treatment - a Prospective, Multicenter, Observational Study in Germany
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- iOMEDICO AG
- 入组人数
- 100
- 试验地点
- 18
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
Cholangiocarcinoma is a rare and aggressive tumor of the bile duct associated with a poor prognosis and very limited treatment options. The IDH1 inhibitor ivosidenib provides a new, targeted treatment option for this disease. Ivosidenib was approved by European Medicines Agency (EMA) in May 2023 as monotherapy in adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.
The prospective, multicenter, observational study IDHIRA will collect first real-world data on ivosidenib treatment in a broad patient population in Germany. Ivosidenib will be administered according to the current SmPC. Thus, IDHIRA will generate real-world evidence on effectiveness, quality of life (QoL) and safety of ivosidenib.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age 18 years or older.
- •Histologically confirmed locally advanced or metastatic CCC with a documented IDH1 R132 mutation diagnosed by an appropriate diagnostic test
- •Patients must have at least one prior systemic therapy
- •Decision for treatment with ivosidenib according to current SmPC.
- •Signed written informed consent before or within 6 weeks of first ivosidenib dose (inclusion of patients up to 6 weeks after first ivosidenib intake is allowed for patients not participating in the PRO module)
- •For patients participating in the PRO module (optional):
- •Dated signature of informed consent form before start of study treatment.
- •Willingness and capability to participate in PRO assessment in German language.
- •Other criteria according to current SmPC.
排除标准
- •Participation in an interventional clinical trial within 30 days prior to enrolment or concurrent participation in an interventional clinical trial except for the follow-up period.
- •Other contraindications according to current SmPC.
结局指标
主要结局
Progression-free survival (PFS)
时间窗: max. 38 months (FPI - LPLV)
PFS is defined as the time interval measured from the day of first ivosidenib administration to first progression or death, whichever comes first. Patients without tumor progression or death at the time of analysis will be censored at their date of last contact.
次要结局
- Overall survival (OS)(max. 38 months (FPI - LPLV))
- Timt to treatment failure (TTF)(max. 38 months (FPI - LPLV))
- Overall response rate (ORR)(max. 38 months (FPI - LPLV))
- Disease control rate (DCR)(max. 38 months (FPI - LPLV))
- (Serious) adverse events ((S)AE))(max. 38 months (FPI - LPLV))
- (Serious) adverse drug reactions ((S)ADR) related to ivosidenib(max. 38 months (FPI - LPLV))
- Adverse events of special interest (AESI)(max. 38 months (FPI - LPLV))
- Global health-related quality of life during course of treatment(max. 38 months (FPI - LPLV))
- Cholangiocarcinoma-related quality of life during course of treatment(max. 38 months (FPI - LPLV))
- Assessing parameters of physician treatment decision making(max. 30 months (recruitment period))
- Assessing parameters of physician treatment satisfaction(max. 32 months (recruitment period plus 8 weeks))
- Cumulative ivosidenib dose(max. 38 months (FPI - LPLV))
- Absolute dose intensity of ivosidenib(max. 38 months (FPI - LPLV))
- Relative dose intensity of ivosidenib(max. 38 months (FPI - LPLV))
- Frequency of dose modifications(max. 38 months (FPI - LPLV))
- Type of dose modifications(max. 38 months (FPI - LPLV))
- Reasons for dose modifications(max. 38 months (FPI - LPLV))
- Duration of treatment with ivosidenib(max. 38 months (FPI - LPLV))
- Reasons for end of treatment (EOT)(max. 38 months (FPI - LPLV))
- Type of last previous therapy(max. 38 months (FPI - LPLV))
- Frequency of last previous therapy(max. 38 months (FPI - LPLV))
- Duration of last previous therapy line(max. 38 months (FPI - LPLV))
- Concomitant medications(max. 38 months (FPI - LPLV))
- Concomitant medications known to induce QT prolongation(max. 38 months (FPI - LPLV))
- Subsequent antineoplastic therapies(max. 38 months (FPI - LPLV))