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Phase Ib Biomarker Trial of Naproxen in patients at risk for DNA Mismatch Repair Deficient Colorectal Cancer

Trial Summary

This randomized phase Ib trial studies the side effects of naproxen in preventing deoxyribonucleic acid (DNA) mismatch repair deficient colorectal cancer in patients with Lynch syndrome. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of naproxen may keep cancer from forming in patients with Lynch syndrome.


Patients are randomized to 1 of 3 treatment arms.

  • ARM I: Patients receive high-dose naproxen (440 mg) orally (PO) once daily (QD) for 6 months.
  • ARM II: Patients receive low-dose naproxen (220 mg) PO QD and placebo PO QD for 6 months.
  • ARM III: Patients receive placebo PO QD for 6 months.

After completion of study treatment, patients are followed up for 2 weeks.


Target Randomizable Enrollment: 80

Target Evaluable Enrollment: 45