drugset / Trial / NCT03317119

Trametinib and Trifluridine and Tipiracil Hydrochloride in Treating Patients With Colon or Rectal Cancer That is Advanced, Metastatic, or Cannot Be Removed by Surgery

NCT03317119

NaSingle-groupOpen-labelTreatment

Summary

This phase I trial studies the side effects and best dose of trametinib and trifluridine and tipiracil hydrochloride in treating patients with colon or rectal cancer that has spread to other places in the body (advanced/metastatic) or cannot be removed by surgery. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as trifluridine and tipiracil hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving trametinib and trifluridine and tipiracil hydrochloride may prevent cancer cells from dividing and work better in treating patients with colon and rectal cancer.

Timeline

Start
2018-04-11
Primary completion
2023-07-14
Completion
2023-07-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Tipiracil Small molecule Oral
Subject Trametinib Small molecule 2 mg Oral
Subject Trifluridine Small molecule Oral