drugset / Trial / NCT04564898

Trifluridine/Tipiracil in Combination With Capecitabine and Bevacizumab in Metastatic Colorectal Cancer Patients.

NCT04564898 ↗

Phase 1/2 Active not recruiting 48 enrolled Gruppo Oncologico del Nord-Ovest
NaSingle-groupOpen-labelTreatment

Summary

The aim oh this study is to determine the safety and recommended dose of trifluridine/tipiracil plus capecitabine and bevacizumab combination (part 1, dose escalation phase) and to assess its activity in previously untreated mCRC patients who are deemed not eligible for intensive chemotherapy (part 2, expansion phase).

Timeline

Start
2022-01-25
Primary completion
2024-05-29
Completion
2026-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 5 mg/kg Intravenous
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Trifluridine/Tipiracil Unknown 25 mg/m2 Oral
Subject Trifluridine/Tipiracil Unknown 35 mg/m2 Oral

Indications