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Retrospective Evaluation of 5-FU Exposure Optimization in CRC Patients

NCT02055560 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 146

Last updated 2022-02-17

No results posted yet for this study

Summary

The primary objective of this study is to evaluate whether the management of colorectal cancer (CRC) patients with 5-fluorouracil (5-FU) exposure optimization testing reduces 5-FU related toxicities and improves outcomes compared to the current standard of care. A secondary objective is to characterize the variability of 5-FU levels among CRC patients managed with 5-FU exposure optimization testing and the impact of such management on 5-FU plasma levels and drug doses during the course of chemotherapy.

Conditions

Sponsors & Collaborators

  • Saladax Biomedical, Inc.

    lead INDUSTRY

Principal Investigators

  • Craig Miller, B.S. · Saladax Biomedical, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-04-02
Completion
2015-12-18

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02055560 on ClinicalTrials.gov