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

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

January 25, 2022

Primary Completion Date

May 29, 2024

Study Completion Date

December 31, 2025

Conditions
Colorectal Cancer Metastatic
Interventions
DRUG

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"

DRUG

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"

DRUG

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"

Trial Locations (2)

20133

Fondazione IRCCS Istituto Nazionale Tumori, Milan

56126

Azienda Ospedaliero Universitaria Pisana, Pisa

All Listed Sponsors
lead

Gruppo Oncologico del Nord-Ovest

OTHER