NCT06081829进行中（未招募）2 期
A Phase 2, Open-label, Multicenter Study of Orally Administered Ivosidenib in Previously Treated Japanese Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Servier
- 入组人数
- 12
- 试验地点
- 7
- 主要终点
- 6-month Progression Free Survival (PFS) Rate
研究概览
简要总结
This study will enroll participants with nonresectable or metastatic cholangiocarcinoma with an Isocitrate dehydrogenase protein, 1 (IDH1) mutation, who have previously received at least 1, but no more than 2, prior regimens for advanced disease. All participants will receive ivosidenib daily throughout multiple 28 day cycles. Study treatment will be administered until participant experiences unacceptable toxicity, disease progression, or other discontinuation criteria are met. Study visits will be conducted every week during Cycle 1 (Days 1, 8, 15, and 22), every other week during Cycles 2 and 3, and Day 1 of each cycle thereafter. After the last dose of treatment, participants will attend an end of treatment and a post-treatment follow-up visit, and participants will be followed to assess overall survival. Study visits may include a tumor assessment, physical exam, electrocardiogram (ECG), blood and urine analysis, and questionnaires.
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
- •Have nonresectable or metastatic cholangiocarcinoma and are not eligible for curative resection, transplantation or ablative therapies
- •Have documented IDH1 gene-mutated disease from a tumor biopsy
- •Have an ECOG PS score of 0 or 1
- •Have an expected survival of 3 months or more
- •Have at least one evaluable and measurable lesion
- •Have disease progression following the most recent of 1 or 2 prior systemic regimens for advanced disease with progression on the treatment that was most recently given at a minimum, and must have received at least 1 gemcitabine- or 5-FU -containing regimen
- •Have recovered from side effects associated with the prior treatment therapy
- •Have adequate bone marrow function
- •Have adequate hepatic (liver) and renal (kidney) function
- •Women of child bearing potential must have a negative serum pregnancy test before starting study treatment, and use birth control during the study and for 90 days after the last dose of ivosidenib
- •Fertile men with female partners of child bearing potential must use birth control during the study and for 90 days after the last dose of ivosidenib
排除标准
- •Received a prior IDH inhibitor.
- •Have known symptomatic brain metastases requiring steroids.
- •Pregnancy, possibility of becoming pregnant during the study and breast-feeding women or woman who plans to restart breast-feeding after the study drug administration/intake.
- •Are taking known strong cytochrome P450 (CYP) 3A4 inducers or sensitive CYP3A4 substrate medications with a narrow therapeutic window
- •Have significant heart disease, including congestive heart failure, myocardial infarction (heart attack) unstable angina (chest pain) and/or stroke, within 6 months before starting the study
- •Have a heart-rate corrected QT interval ≥450 msec or other factors that increase the risk of QT prolongation or arrhythmic events
- •. Have active inflammatory gastrointestinal disease, chronic diarrhea, previous gastric resection or lap band dysphagia, short-gut syndrome, gastroparesis (paralysis of the stomach), or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.
- •Have known medical history of progressive multifocal leukoencephalopathy (PML)
研究组 & 干预措施
Open-Label Ivosidenib
Experimental
250 mg Tablets
干预措施: Ivosidenib (Drug)
结局指标
主要结局
6-month Progression Free Survival (PFS) Rate
时间窗: Through 6 months after the first dose
Proportion of subjects who are alive and progression-free (using RECIST v1.1) at 6 months after Day 1 (C1D1) per Independent Radiology Center (IRC)
次要结局
- Progression Free Survival (PFS)(Approximately 1 year)
- Overall Survival (OS)(Approximately 1 year)
- Duration of Response (DOR)(Approximately 1 year)
- Total Number of Participants With Adverse Events (AEs) Leading to Dose Modifications(Approximately 1 year)
- Total Number of Participants With Adverse Events (AEs) Leading to Discontinuation(Approximately 1 year)
- Objective Response (OR) Rate(Approximately 1 year)
- Time to Response (TTR)(Approximately 1 year)
- Change From Baseline in Health-Related Quality of Life Using EORTC-QLQ-C30 Questionnaire Scores.(Baseline and 1 year)
- Change From Baseline in Health-Related Quality of Life Using EORTC-QLQ-BIL21 Questionnaire Scores.(Baseline and 1 year)
- Total Number of Adverse Events (AEs)(Approximately 1 year)
- Average EQ-5D-5L VAS Scores(Baseline, Cycle 3 Day 1 (cycle = 28 days), and End of Treatment Visit (within 5 to 33 days after last dose of treatment, approximately 1 year total))
- Total Number of Participants With Serious Adverse Events (SAEs)(Approximately 1 year)
- Total Number of Participants With Adverse Events (AEs) Leading to Death(Approximately 1 year)
- Average Area Under the Concentration-vs Time Curve From 0 to Time of Last Measurable Concentration (AUC0-t)(Cycle 1 Day 1 and Cycle 2 Day 1)
- Average AUC Over 1 Dosing Interval at Steady State (AUCtau,ss)(Cycle 2 Day 1)
- Average Time to Maximum Concentration (Tmax)(Cycle 1 Day 1 and Cycle 2 Day 1)
- Average Maximum Concentration (Cmax)(Cycle 1 Day 1 and Cycle 2 Day 1)
- Average Trough Concentration (Ctrough)(Cycle 2 Day 1)
- Average Plasma 2-hydroxyglutarate (2-HG) Concentrations(Cycle 1 Day 1 and Cycle 2 Day 1)
- Number of Participants With no Change, Plus 1 or Plus 2 Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (ECOG PS) Score(Approximately 1 year)
研究者
研究点 (7)
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