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

Sponsor
Gruppo Oncologico del Nord-Ovest
Study ID
NCT04564898
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Capecitabine — DRUG
    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 — DRUG
    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 — DRUG
    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

Study Details

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).

Key Dates

First listed
Sep 25, 2020
Start date
Jan 25, 2022
Status verified
May 2026
Primary completion
May 29, 2024
Completion
Nov 30, 2026

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: trifluridine/tipiracil plus capecitabine and bevacizumab

Primary Outcome Measure

recommended dose [ Time Frame: 2 years ]

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