Safety of HRX215 in Patients After Minor and Major Liver Resection

Purpose

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.

Conditions

  • Liver Resection
  • Colorectal Carcinoma Liver Metastases

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts 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 exclusion criteria apply

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Drug: HRX215 capsules
    HRX215 250 mg orally twice daily for a total treatment duration of 28 days
Experimental
Active treatment major hepatic resection 		Pilot 2: 10 participants will receive HRX215 starting treatment prior to major liver resection for colorectal liver metastases.
  • Drug: HRX215 capsules
    HRX215 250 mg orally twice daily for a total treatment duration of 28 days
Placebo Comparator
Major hepatic resection (Randomized part control arm) 		32 participants will receive placebo starting administration prior to major liver resection for colorectal liver metastases
  • Drug: Placebo capsules
    placebo matching appearance of HRX215, orally twice daily for a total treatment duration of 28 days
Experimental
Major hepatic resection (Randomized part) 		32 participants will receive HRX215 starting administration prior to major liver resection for colorectal liver metastases.
  • Drug: HRX215 capsules
    HRX215 250 mg orally twice daily for a total treatment duration of 28 days

Recruiting Locations

Mayo Clinic
Rochester, Minnesota 55905

Cleveland Clinic
Cleveland, Ohio 44195
Contact:
Frederico Aucejo, MD
216-444-0537
aucejof@ccf.org

More Details

Status
Recruiting
Sponsor
HepaRegeniX GmbH

Study Contact

Wolfgang Albrecht, PhD NC
+49 7071 7912809
info@heparegenix.com

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.