Colorectal Carcinoma Liver Metastases, Liver Resection
Conditions
Brief summary
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: 1. to learn about the safety and tolerability of HRX215 2. to learn about how the body absorbs, distributes, and gets rid of HRX215. 3. 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.
Detailed description
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.
Interventions
DRUGHRX215 capsules
HRX215 250 mg orally twice daily for a total treatment duration of 28 days
DRUGPlacebo capsules
placebo matching appearance of HRX215, orally twice daily for a total treatment duration of 28 days
Sponsors
HepaRegeniX GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Liver Cirrhosis * Preoperative presence of clinical ascites * Any other hepatobiliary cancer * BMI \>35 kg/m2 * ASA Score \>4 * Peritoneal carcinomatosis Further
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AEs) observed | 6 months | Incidence, severity, and relatedness of AEs/SAEs. Changes in vital signs and physical examination findings. Clinical laboratory investigation. |
| HRX215 plasma levels | 28 days | Levels of drug (HRX215) at selected time intervals after drug administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy (major liver resection) | 7 days | Liver volume and increase in liver volume at postoperative day 7 vs. postoperative day 1 |
Countries
France, Germany, Israel, Spain, United States
Contacts
CONTACTWolfgang Albrecht, PhD NC
CONTACTLinda Greenbaum, MD
STUDY_DIRECTORLinda E Greenbaum, MD
HepaRegeniX GmbH
PRINCIPAL_INVESTIGATORPatrick Starlinger, MD, PhD
Mayo Clinic
Outcome results
None listed