Table of Contents
- Trial overview
- Who is being studied
- Trial phases and goals
- What the trials measure
- Treatment context and comparison group
- Study details at a glance
Trial overview
The available trial data describe one interventional study, which means people are assigned to receive a study treatment so researchers can observe the effects.[1]
This study is testing ARFOLITIXORIN in people with metastatic colorectal cancer, a cancer of the colon or rectum that has spread to other parts of the body.[1]
The trial is authorised and plans to include 90 participants.[1]
Who is being studied
The study population is patients with metastatic colorectal cancer.[1]
The trial also focuses on the first-line treatment setting, meaning treatment given as the first main therapy for the cancer.[1]
This tells patients and families that the study is aimed at people starting treatment for advanced disease, not at people who have already gone through many prior treatment steps.[1]
Trial phases and goals
This study is described as a Phase 1b/2 trial.[1]
In Phase 1b, the main goal is to evaluate safety and tolerability of ARFOLITIXORIN with other treatment drugs, and to find the maximum tolerated dose, which is the highest dose that can be given without unacceptable side effects.[1]
In Phase 2, the study looks again at safety and also checks for early signs that the treatment may help control the cancer.[1]
The Phase 2 part uses two pre-defined dose levels of ARFOLITIXORIN, including the dose at the maximum tolerated dose and a dose below it.[1]
What the trials measure
The main safety measures are adverse events, which are medical problems that happen during the study, even if they are not clearly caused by the treatment.[1]
The trial also tracks clinically significant abnormal laboratory findings, which means blood test or other lab results that are outside the normal range and matter medically.[1]
In Phase 1b, these safety results are used to help determine the maximum tolerated dose.[1]
In Phase 2, the study measures overall response rate, which is the proportion of patients whose cancer has a complete response or partial response.[1]
A complete response means no visible cancer remains on scans, while a partial response means the cancer has shrunk but not disappeared.[1]
The Phase 2 study also measures duration of response, which is how long the cancer response lasts after it is first seen.[1]
Responses are measured from the start of study treatment until the end of treatment using RECIST version 1.1, a standard system for measuring tumor changes on scans.[1]
Treatment context and comparison group
The trial summary says ARFOLITIXORIN is being studied with 5-fluorouracil-based treatment regimens and other standard treatment drugs in metastatic colorectal cancer.[1]
The Phase 1b part evaluates ARFOLITIXORIN, 5-FU, oxaliplatin, and bevacizumab together as an ARFOX-based regimen.[1]
The Phase 2 part compares the ARFOLITIXORIN-based approach with standard of care, which means the usual treatment used in routine practice.[1]
The study uses standard of care as an internal control, meaning the comparison is built into the same trial rather than using a separate outside study group.[1]
