« Return to News | Clinical Intelligence

CESAR and Saladax collaborate on a study of optimized 5-FU dosing in colorectal cancer patients

Tuesday, February 14, 2012 07:33 AM

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.

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

Already a subscriber?
Log in to your digital subscription.

Purchase the January issue.

Subscribe to The CenterWatch Monthly.

December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

Already a subscriber?
Log in to your digital subscription.

Purchase the December issue.

Subscribe to The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs

More Jobs

 

Copyright © 1995-2013 CenterWatch.