Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy.

Sponsor
Institut de Recherches Internationales Servier
Study ID
NCT03869892
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • Trifluridine/tipiracil hydrochloride (S95005) — DRUG
    Film-coated tablets of S 95005 (35 mg/m²/dose) will be administered orally twice a day (BID), within 1 hour after completion of morning and evening meals, 5 days on/2 days off, over 2 weeks, followed by a 14-day rest; This treatment cycle will be repeated every 4 weeks.
  • Capecitabine — DRUG
    Film-coated tablets, Capecitabine (1250 mg/m²/dose) will be administered orally BID on Days 1-14 of each cycle. This treatment cycle will be repeated every 3 weeks.
  • Bevacizumab experimental — BIOLOGICAL
    Concentrate for solution for infusion, Bevacizumab (5 mg/kg, IV) administered every 2 weeks (Day 1 and Day 15). This treatment cycle will be repeated every 4 weeks.
  • Bevacizumab control — BIOLOGICAL
    Concentrate for solution for infusion, Bevacizumab (7.5 mg/kg, IV) will be administered on Day 1 of each cycle.This treatment cycle will be repeated every 3 weeks.

Study Details

The main purpose of this study is to demonstrate the superiority of S 95005 in combination with bevacizumab over capecitabine in combination with bevacizumab.

Key Dates

First listed
Mar 11, 2019
Start date
Mar 21, 2019
Status verified
Dec 2025
Primary completion
Jun 29, 2021
Completion
Dec 31, 2026

Study Design

Enrollment
856 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: S95005 + Bevacizumab
  • Active Comparator: Capecitabine + Bevacizumab

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Up to 24 months ]

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