Clinical Trials Directory

Trials / Completed

CompletedNCT02743221

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

An Open-label, Randomised, Non-comparative Phase 2 Study Evaluating S 95005 (TAS-102) Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Metastatic COlorectal Cancer Who Are Non-eligible for Intensive Therapy (TASCO1 Study).

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
154 (actual)
Sponsor
Institut de Recherches Internationales Servier · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

TypeNameDescription
DRUGTrifluridine/tipiracil + bevacizumabPatients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.
DRUGCapecitabine + bevacizumabPatients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion.

Timeline

Start date
2016-04-29
Primary completion
2018-01-15
Completion
2020-09-01
First posted
2016-04-19
Last updated
2024-08-20
Results posted
2019-04-16

Locations

57 sites across 12 countries: Australia, Belgium, Brazil, Denmark, France, Germany, Italy, Netherlands, Poland, Russia, Spain, United Kingdom

Source: ClinicalTrials.gov record NCT02743221. Inclusion in this directory is not an endorsement.