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

NCT03869892 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 856

Last updated 2025-12-22

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Trifluridine/tipiracil hydrochloride (S95005)

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.

DRUG

Capecitabine

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.

BIOLOGICAL

Bevacizumab experimental

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.

BIOLOGICAL

Bevacizumab control

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.

Sponsors & Collaborators

  • ADIR, a Servier Group company

    collaborator INDUSTRY

  • Institut de Recherches Internationales Servier

    lead OTHER

Principal Investigators

  • Thierry ANDRE, PhD · Medical Oncology departement Saint-Antoine hospital (Paris France 75012)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-21
Primary Completion
2021-06-29
Completion
2026-12-31

Countries

  • Argentina
  • Australia
  • Austria
  • Brazil
  • Bulgaria
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03869892 on ClinicalTrials.gov