MedTrace Logo

A Study Evaluating S 95005 Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Colorectal Cancer Who Are Non-eligible for Intensive Therapy

NCT02743221 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2024-08-20

Study results available
· View outcomes & findings →

Summary

The main purpose of this study is to evaluate the progression-free survival (PFS) in patients receiving S 95005 + bevacizumab (experimental arm) or capecitabine + bevacizumab (control arm) as first-line treatment for unresectable metastatic colorectal cancer in patients non-eligible for intensive therapy.

Conditions

Interventions

DRUG

Trifluridine/tipiracil + bevacizumab

Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.

DRUG

Capecitabine + bevacizumab

Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion.

Sponsors & Collaborators

  • ADIR, a Servier Group company

    collaborator INDUSTRY

  • Institut de Recherches Internationales Servier

    lead OTHER

Principal Investigators

  • Eric Van Custem, Prof · Leuven Cancer Institute, University Hospitals Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-29
Primary Completion
2018-01-15
Completion
2020-09-01

Countries

  • Australia
  • Belgium
  • Brazil
  • Denmark
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Russia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT02743221 on ClinicalTrials.gov