A Phase 2, Single-Arm, Open-label, Study of RRx-001 in Second Line Treatment of Advanced Cholangiocarcinoma Prior to Readministration of First-Line Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Overall Objective Response (RECIST)
研究概览
简要总结
The purpose of this study is to see if the investigational drug, RRx-001, an epigenetic agent, which turns on a number of beneficial genes that the tumor has silenced, can resensitize the tumor(s), in other words make it/them re-respond to gemcitabine and cisplatin, which, hopefully, will translate to a longer lifespan. The name of the open-label study, which means that patients will know what treatments they are receiving, is EPIC, a hybrid or combination of EPIgenetic for the mechanism of action of RRx-001 and Cholangiocarcinoma.
The study treatment is divided into two stages. During the first stage, patients will receive RRx-001, which is administered intravenously weekly, for a fixed time period of six weeks. At that time the second stage starts in which cisplatin and gemcitabine are reintroduced for as long as the tumors respond to them to determine whether resensitization has occurred.
The primary objective of this clinical trial is to evaluate the progression-free survival (PFS) of patients at 9 weeks after the reintroduction of gemcitabine and cisplatin.
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
- •Histologically or cytologically confirmed diagnosis of biliary tract adenocarcinoma/cholangiocarcinoma
- •Must have locally advanced or distant metastatic disease that is not surgically curable
- •Failed first-line chemotherapy
- •Age ≥ 18 years
- •Life expectancy of at least 12 weeks (3 months)
- •Performance status 0 or 1
- •Adequate liver, kidney, and bone marrow function
排除标准
- •Symptomatic metastatic brain or meningeal tumors
- •Investigational compound within 4 weeks of enrollment
- •History of needing to permanently discontinue prior gemcitabine/ cisplatin regimen for reasons other than progression (i.e. toxicity)
- •Any medical condition which, in the investigator's opinion, makes the patient unsuitable for participation
- •Pregnant or nursing
- •Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
- •Albumin <2.8
- •Uncontrolled or clinically relevant ascites
- •Absolute contraindication for MRI imaging such as intracorporeal metal or pacemaker
研究组 & 干预措施
RRx-001 the cisplatin and gemcitabine
Patients with advanced and metastatic biliary tract adenocarcinoma (cholangiocarcinoma) who had been treated with and failed first-line chemotherapy will be treated with RRx-001 (20 mg) intravenously weekly for up to six weeks followed by retreatment with Gemcitabine 1000 mg/m2 and Cisplatin 25 mg/m2 on Days 1 and 8 of a 21 Day Cycle until tumor progression
干预措施: RRx-001 (Drug)
RRx-001 the cisplatin and gemcitabine
Patients with advanced and metastatic biliary tract adenocarcinoma (cholangiocarcinoma) who had been treated with and failed first-line chemotherapy will be treated with RRx-001 (20 mg) intravenously weekly for up to six weeks followed by retreatment with Gemcitabine 1000 mg/m2 and Cisplatin 25 mg/m2 on Days 1 and 8 of a 21 Day Cycle until tumor progression
干预措施: Gemcitabine and cisplatin (Drug)
结局指标
主要结局
Overall Objective Response (RECIST)
时间窗: Baseline and every 6-8 weeks while on treatment until progression. Estimated 8 -24 weeks.
Overall objective response (RECIST)
次要结局
未报告次要终点