Testing a cancer drug in patients with liver problems

Plain-English translation of NCT04617522 on ClinicalTrials.gov ↗ · Source last updated June 2026 · Translation generated June 2026 · How we translate trials

Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.

What is this trial?

This trial is testing a cancer drug called in patients who have advanced or metastatic solid tumors and moderate liver problems. The main goal is to find the right dose of this medication that is safe and works well for people whose livers don't function normally. Researchers will carefully watch how your body responds to different doses of the treatment.

Most cancer drugs are tested in patients with normal liver function, but people with liver problems may process medications very differently and could experience worse side effects. This trial fills that gap by studying how this medication works specifically in patients with moderate liver impairment, so doctors can eventually treat these patients more safely.

Do you qualify?

You likely qualify if…

you have been diagnosed with an advanced or metastatic solid tumor (cancer that has spread)
you have moderate liver impairment with specific blood test results in a certain range
you have adequate blood cell counts without recent transfusions or growth factor support
your kidney function meets minimum requirements as measured by creatinine clearance
you are well enough to do light activity (ECOG performance score of 0, 1, or 2)

You likely don't qualify if…

you have had recent chemotherapy, radiation, or other cancer drugs within the past 2 weeks that you haven't fully recovered from
you have had prior treatment with irinotecan within the past 4 weeks
you have active cancer in your brain or spinal cord (or cancer that has spread to the lining around your brain)
you have a history of heart disease or are taking high-dose steroids
you have a known history of Gilbert's disease or are taking certain medications that interact with how your body processes this drug

What participation looks like

You would receive intravenous infusions of the medication on Days 1 and 8 of each cycle. If you have moderate liver problems, your starting dose would be lower and may increase over time if it is well tolerated. If your liver functions normally, you would receive the standard dose. The research team will monitor your blood counts, liver and kidney function, and any side effects throughout the study. If the treatment is helping you, you may be able to continue receiving it in a separate follow-up study after this one ends.

AI-generated summary from trial data · Jun 19, 2026 · Not medical advice

Trial locations(15 sites)

United States

Pacific Shores Medical Group, Long Beach, California

Christiana Care Health Services, Newark, Delaware

University of Maryland, Baltimore, Maryland

NEXT Austin, Austin, Texas

Oncology Consultants, P.A., Houston, Texas