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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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).

NCT02743221•Institut de Recherches Internationales Servier

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Written informed consent obtained.
•Has ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1 or 2 at the time of the randomisation.
•Has definitive histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
•RAS status must have been determined (mutant or wild).
•Has at least one measurable metastatic lesion.
•No previous systemic anticancer therapy for unresectable metastatic colorectal cancer.
•Previous adjuvant (or neoadjuvant for patients with rectal cancer) chemotherapy is allowed only if if it has been completed more than 6 months before start of study treatment.
•Patient is not a candidate for combination chemotherapy with irinotecan or oxaliplatin, or for curative resection of metastatic lesions.
•Is able to take medication orally (i.e., no feeding tube).
•Has adequate organ function.
+2 more criteria

Exclusion Criteria

•Is a pregnant or lactating female.
•Has certain serious illness or serious medical condition(s) as described in the protocol.
•Has had certain other recent treatment e.g. major surgery, field radiation, received investigational agent, within the specified time frames prior to randomisation.
•Has previously received Trifluridine/tipiracil or history of allergic reactions attributed to compounds of similar composition to Trifluridine/tipiracil or any of its excipients.
•Has rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
•Has contra-indication to bevacizumab or capecitabine.

Locations (57)

Chris O'Brien Lifehouse Oncology

Camperdown, Australia

Austin Hospital Olivia Newton-John Cancer & Wellness Centre

Heidelberg, Australia

Western Health, Sunshine Hospital

Saint Albans, Australia

The Queen Elizabeth Hospital Haematology and Oncology Unit

Woodville, Australia

Grand Hôpital de Charleroi Oncologie-Hématologie

Charleroi, Belgium

UZ Leuven Campus Gasthuisberg Digestieve Oncologie

Leuven, Belgium

CHC Saint-Joseph Oncologie-Hématoimmunopathologie

Liège, Belgium

Hospital do Câncer de Barretos - Fundação Pio XII

Barretos, Brazil

Centro de Pesquisa Hospital de Caridade de Ijuí

Ijuí, Brazil

Instituto Nacional do Câncer - INCA Unidade de Pesquisa ClínicaInstituto Nacional do Câncer - INCA Unidade de Pesquisa Clínica

Rio de Janeiro, Brazil

Key Dates

Start Date

April 29, 2016

Primary Completion Date

January 15, 2018

Completion Date

September 1, 2020

Last Updated

August 20, 2024

Enrollment

154

ACTUAL participants

Conditions

Metastatic Colorectal Cancer

Interventions

Trifluridine/tipiracil + bevacizumab

DRUG

Capecitabine + bevacizumab

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 20, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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