Saladax Biomedical and the Central European Society for Anticancer Drug Research (CESAR) will be collaborating in a single-arm study of metastatic colorectal cancer patients treated with the chemotherapy drug 5-fluorouracil (5-FU).
CESAR will sponsor the Saladax-supported study designed to determine whether target blood levels of 5-FU can be maintained throughout the course of treatment by optimizing the dose administered to individual patients at each infusion. Doses in the study will be optimized based on actual 5-FU blood levels, which will be measured using Saladax's My5-FU automated immunoassay technology.
The goals of the study are to achieve a stable target blood level of 5-FU and to determine whether this dose optimization is able to reduce 5-FU-related toxicities.
“We expect that the 5-FU clinical trial we are undertaking will add to the growing body of evidence that pharmacokinetic optimization of 5-FU dosing has the potential to markedly improve patient quality of life through a reduction of grade 3/4 mucositis and diarrhea, which can result in hospitalization and premature treatment termination,” explained Dr. Martin Wilhelm of CESAR, chair of the study.
The four-center study is planned to enroll 80 metastatic colorectal cancer patients and is expected to be completed within one year. Individual patients will remain on study until a total of six doses of 5-FU treatment have been administered and the end-of-treatment visit has been performed.