48
Participants
Start Date
January 25, 2022
Primary Completion Date
May 29, 2024
Study Completion Date
December 31, 2025
Capecitabine
"Part 1 • Capecitabine, 1000 mg/sqm orally twice daily on days 1-14 each 28 days~Part 2~• Capecitabine, 1000 mg/sqm orally twice daily on days 1-14 each 28 days"
Bevacizumab
"Part 1 • Bevacizumab, 5 mg/kg IV dose over 30 minutes on days 1 and 15 each 28 days~Part 2~• Bevacizumab, 5 mg/kg IV dose over 30 minutes on days 1 and 15 each 28 days"
Trifluridine/Tipiracil
"Part 1 • Trifluridine/tipiracil, dose escalation from 25 mg/sqm to 35 mg/sqm orally twice daily on days 15-19 (and days 22-26) each 28 days~Part 2~• Trifluridine/tipiracil, at the recommanded dose established during part 1 orally twice daily on days 15-19 (and days 22-26) each 28 days"
Fondazione IRCCS Istituto Nazionale Tumori, Milan
Azienda Ospedaliero Universitaria Pisana, Pisa
Gruppo Oncologico del Nord-Ovest
OTHER