The AGENT Study

The AGENT Study

If you or a loved one has metastatic colorectal cancer, you may qualify for the AGENT Study (ISO-CC-007). This study is evaluating arfolitixorin as a new experimental therapy for the treatment of mCRC. The study is a multicenter, randomized, parallel-group Phase 3 study with two arms being run in approximately 80 sites in the U.S., Canada, and Europe.

The AGENT Study will enroll approximately 440 mCRC patients, aged 18 years or over. Patients will receive either arfolitixorin in combination with chemotherapy, or the standard of care, leucovorin in combination with chemotherapy. The study will evaluate multiple endpoints including overall response rate (ORR), progression free survival (PFS), and duration of response (DOR). ORR is defined as the best tumor reduction response recorded from the start of the study treatment to the end of the treatment; PFS is the length of time during and after the treatment that a patient lives with mCRC without the disease getting worse; DOR is the time from initial tumor response to disease progression. 

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Glossary


Control - an experiment or observation intended to help minimize the effects of all variables in a study that are not the target of the study itself


Clinical study - an organized research program used to evaluate the safety and effectiveness of a new medical treatment or device


Clinical study coordinator - a person with administrative responsibilities at an individual clinical study site that helps with enrollment and maintaining contact with patients and study organizers


Contract research organization - a third party company often hired to handle the logistics of running a large-scale clinical study that involves multiple clinical study sites


Duration of response (DOR) - time between the initial response to therapy and subsequent disease progression or relapse


Eligibility criteria - pre-defined standards used to determine if a person is able to take part in a clinical study


Endpoints - biomedical or behavioral measures of whether or not a treatment or device is effective determined during study design


First-line treatment - the first treatment a patient receives for a certain stage of disease


Food and Drug Administration (FDA) - a federal agency of the U.S. charged with ensuring the safety of food and drugs. The main federal oversight organization for all clinical studies


Health-related biomedical or behavioral outcomes - conditions that can be used to reflect or measure the overall health of an individual (for example: heart rate, lung capacity, disease progression measures such as tumor size, etc.)


Intervention - a treatment or process that is a focus of a clinical study. For example, giving a study subject a new experimental drug is an intervention, as is giving someone a placebo


MTHF - Methylenetetrahydrofolate


Overall response rate (ORR) - portion of patients with a tumor size reduction of a predefined amount


Phase - the name for a stage of clinical testing


Placebo - an inactive substance or other innocuous intervention that looks the same as and is given the same way as the experimental drug or intervention that is the focus of a study


Principal investigator - the person who is responsible for the scientific and technical direction of the entire clinical study, either at a single clinical study site or over the whole study


Progression free survival (PFS) - time during and after treatment of a disease that a patient lives with the disease without it getting worse


Toxicology - a branch of science concerned with measuring the nature and effects of poisons or other harmful agents