A Multicenter Open-Label Dose Optimization Trial of Devimistat in Combination With Modified FOLFIRINOX in Patients With Metastatic Adenocarcinoma of the Pancreas
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of subjects with dose-limiting toxicity during the first 15 days of devimistat in combination with modified FOLFIRINOX in the dose escalation cohort
研究概览
简要总结
This protocol will enroll patients with metastatic pancreatic cancer to receive modified FOLFIRINOX plus devimistat. Patients will be enrolled with 1:1 randomization between Dose Escalation Cohort and Cohort A until required 20 patients have been enrolled on Cohort A following which randomization will end and patients will be enrolled without randomization to Dose Escalation Cohort and then subsequently to Cohort B.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
TiTE-CRM Dose Escalation
Devimistat at Dose Level IV 2 hrs + modified FOLFIRINOX
干预措施: Devimistat (Drug)
TiTE-CRM Dose Escalation
Devimistat at Dose Level IV 2 hrs + modified FOLFIRINOX
干预措施: Modified FOLFIRINOX (Drug)
Expansion Cohort A
Devimistat 500 mg/m2 IV 2 hrs + modified FOLFIRINOX
干预措施: Devimistat (Drug)
Expansion Cohort A
Devimistat 500 mg/m2 IV 2 hrs + modified FOLFIRINOX
干预措施: Modified FOLFIRINOX (Drug)
Expansion Cohort B
Devimistat at MTD IV 4 hrs + modified FOLFIRINOX
干预措施: Devimistat (Drug)
Expansion Cohort B
Devimistat at MTD IV 4 hrs + modified FOLFIRINOX
干预措施: Modified FOLFIRINOX (Drug)
结局指标
主要结局
Number of subjects with dose-limiting toxicity during the first 15 days of devimistat in combination with modified FOLFIRINOX in the dose escalation cohort
时间窗: 15 days post the start of combination therapy
The maximum tolerated dose (MTD) will be determined based on dose limiting toxicity
Median Progression Free Survival (PFS) of devimistat plus modified FOLFIRINOX across all cohorts
时间窗: up to 42 months after enrollment
The PFS will be defined as time from date of initial treatment to date of radiological or clinical progression (leading to withdrawal from the study treatment), or death from any cause on study treatment, whichever comes first. Follow-up time will be censored at the date of last disease evaluation.
次要结局
- Number of subjects with reported adverse events and reportable serious events(up to 25 months after enrollment)
- Overall Survival (OS) of devimistat plus modified FOLFIRINOX(up to 42 months after enrollment)
- Overall Response Rate (ORR) of devimistat plus modified FOLFIRINOX(up to 42 months after enrollment)
- Overall Survival (OS) of devimistat plus modified FOLFIRINOX based on gender(up to 42 months after enrollment)
- Duration of response (DoR) of devimistat plus modified FOLFIRINOX(up to 42 months after enrollment)
- To assess pharmacokinetics (Cmax) of devimistat(up to 42 months after enrollment)
- To assess pharmacokinetics (Vd) of devimistat(up to 42 months after enrollment)
- To determine the median Progression Free Survival (PFS) of devimistat plus modified FOLFIRINOX based on gender(up to 42 months after enrollment)
- To assess pharmacokinetics (AUCinf) of devimistat(up to 42 months after enrollment)
- To assess pharmacokinetics (t1/2) of devimistat(up to 42 months after enrollment)
- To assess pharmacokinetics (tmax) of devimistat(up to 42 months after enrollment)
- To assess pharmacokinetics (CL) of devimistat(up to 42 months after enrollment)