Double-Blind, Randomized, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of HRX215 in Participants After Major Hepatectomy, Preceded by Two Open Pilot Parts in Participants After Minor and After Major Hepatectomy Due to Colon Carcinoma Metastases
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 18
- 主要终点
- Adverse Events (AEs) observed
研究概览
简要总结
The goal of this clinical trial is to learn if HRX215 is safe, tolerable and active in adults who have undergone liver resection due to colorectal carcinoma metastases.
The objectives are:
- to learn about the safety and tolerability of HRX215
- to learn about how the body absorbs, distributes, and gets rid of HRX215.
- to learn about clinical activity of HRX215
Researchers will compare HRX215 to a placebo (a look-alike substance that contains no drug) to investigate safety, tolerability and clinical activity in participants taking HRX215.
详细描述
The study is designed to evaluate primarily the safety of HRX215, first after minor liver resection and subsequently in participants after major liver resection. Participants undergoing major liver resection will start treatment shortly before liver resection surgery and will receive 28 days of treatment with HRX215 or placebo twice daily with follow up visits at 3 and 6 months.
Participants will take HRX215 or a placebo twice a day for 28 days. Daily visits for the first 7 days of treatment for checkups and tests which may either be in the hospital or outpatient after 3 days. Clinic visits every two weeks for the next two visits. Additional clinic visits 3 months and 6 months after the start of treatment.
The pharmacokinetics will be compared with the results of the phase I studies in healthy subjects.
Secondary objectives will include evaluation of liver volume and liver volume increase postoperatively.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with liver metastases originating from colon carcinoma planned for R0-intended hepatectomy for colorectal liver metastases
- •Part 1 only: stable participants within 1-3 days after minor liver resection, normal non-tumor liver parenchyma
- •Part 2 and 3 only: Major liver resection.
- •Low estimated risk for post-hepatectomy liver failure PHLF
- •Further inclusion criteria apply
排除标准
- •Liver Cirrhosis
- •Preoperative presence of clinical ascites
- •Any other hepatobiliary cancer
- •BMI >35 kg/m2
- •ASA Score >4
- •Peritoneal carcinomatosis
- •Further exclusion criteria apply
研究组 & 干预措施
Active treatment minor hepatic resection
Pilot 1: 5 participants will receive HRX215 starting within 1-3 days after minor liver resection for colorectal liver metastases.
干预措施: HRX215 capsules (Drug)
Active treatment major hepatic resection
Pilot 2: 10 participants will receive HRX215 starting treatment prior to major liver resection for colorectal liver metastases.
干预措施: HRX215 capsules (Drug)
Major hepatic resection (Randomized part control arm)
32 participants will receive placebo starting administration prior to major liver resection for colorectal liver metastases
干预措施: Placebo capsules (Drug)
Major hepatic resection (Randomized part)
32 participants will receive HRX215 starting administration prior to major liver resection for colorectal liver metastases.
干预措施: HRX215 capsules (Drug)
结局指标
主要结局
Adverse Events (AEs) observed
时间窗: 6 months
Incidence, severity, and relatedness of AEs/SAEs. Changes in vital signs and physical examination findings. Clinical laboratory investigation.
HRX215 plasma levels
时间窗: 28 days
Levels of drug (HRX215) at selected time intervals after drug administration
• Adverse Events (AEs) observed.
时间窗: 28 days
* Adverse Events (AEs) observed * Clinical laboratory investigation including hematology, blood glucose, HbA1c, serum chemistry: pre-treatment, after 14 and 28 days
次要结局
- Efficacy (major liver resection)(7 days)
- Pharmacokinetic Plasma Analysis(28 days)