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 (TASCO1)

July 24, 2024 updated by: Institut de Recherches Internationales Servier

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).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Camperdown, Australia, NSW 2050
        • Chris O'Brien Lifehouse Oncology
      • Heidelberg, Australia, VIC 3084
        • Austin Hospital Olivia Newton-John Cancer & Wellness Centre
      • Saint Albans, Australia, VIC 3021
        • Western Health, Sunshine Hospital
      • Woodville, Australia, SA 5011
        • The Queen Elizabeth Hospital Haematology and Oncology Unit
  • Belgium
      • Charleroi, Belgium, 6000
        • Grand Hôpital de Charleroi Oncologie-Hématologie
      • Leuven, Belgium, 3000
        • UZ Leuven Campus Gasthuisberg Digestieve Oncologie
      • Liège, Belgium, 4000
        • CHC Saint-Joseph Oncologie-Hématoimmunopathologie
  • Brazil
      • Barretos, Brazil, 14784-400
        • Hospital do Cancer de Barretos - Fundacao Pio XII
      • Ijui, Brazil, 98700-000
        • Centro de Pesquisa Hospital de Caridade de Ijuí
      • Rio de Janeiro, Brazil, 20230-130
        • Instituto Nacional do Câncer - INCA Unidade de Pesquisa ClínicaInstituto Nacional do Câncer - INCA Unidade de Pesquisa Clínica
      • Sao Jose do Rio Preto, Brazil, 15090-000
        • Hospital de Base, Centro Intergrado de Pesquisa
      • Sao Paulo, Brazil, 01246-000
        • Instituto do Câncer do Estado de São Paulo - ICESP, Núcleo de Pesquisa
  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet - Dpt of Oncology
      • Odense, Denmark, 5000
        • Odense Universitetshospital - Department of Oncology
  • France
      • Besançon, France, 25030
        • CHU Jean Minjoz, Service d'oncologie médicale
      • Paris, France, 75012
        • Hôpital Saint Antoine, oncology department
      • Saint-Herblain, France, 44805
        • Centre René Gauducheau, Oncologie Médicale
  • Germany
      • Berlin, Germany, 10707
        • Onkologische Schwerpunktpraxis Kurfürstendamm
      • Magdeburg, Germany, 39104
        • Schwerpunktpraxis für Hämatologie und Onkologie
      • Munich, Germany, 81737
        • Städtisches Krankenhaus München Neuperlach, Klinik für Onkologie und Hämatologie
  • Italy
      • Brescia, Italy, 25124
        • Fondazione Poliambulanza Istituto Ospedaliero, Clinical Oncology
      • Genova, Italy, 16132
        • A.O.U. SanMartino-IST, Unità Operativa Oncologia Medica 1
      • Milan, Italy, 20162
        • A.O. Ospedale Niguarda Ca' Granda-Milano, Department of Onco-Haematology- Onoclogia Falck
      • Naples, Italy, 80131
        • Seconda Università degli Studi di Napoli, U.O.C. di Oncologia Medica ed Ematologia
      • Pisa, Italy, 56126
        • .O.U. Pisana-Ospedale Santa Chiara, U.O. di Oncologia Medica 2
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • AMC Academisch Medisch Centrum Medische Oncologie
      • Breda, Netherlands, 4819 EV
        • Amphia Ziekenhuis, Interne Geneeskunde/Oncologie, Langendijk 75
      • Eindhoven, Netherlands, 5623 EJ
        • Catharina Ziekenhuis, Interne Geneeskunde/Oncologie
      • Groningen, Netherlands, 9728 NT
        • Martini Ziekenhuizen, Interne Geneeskunde/Oncologie, Van Swietenplein 1
      • Hilversum, Netherlands, 1213 XZ
        • Tergooi Hilversum, Medische Oncologie, Van Riebeeckweg 212
      • Sittard, Netherlands, 6162 BG
        • Zuyderland Medisch Centrum Interne Geneeskunde
      • Utrecht, Netherlands, 3543 CX
        • Sint Antonius Ziekenhuis Interne Geneeskunde/Oncologie
      • Venlo, Netherlands, 5912 BL
        • VieCurie Medisch Centrum, Interne Geneeskunde, Tegelseweg 210
      • Zwolle, Netherlands, 8025 AB
        • Isala Klinieken, Medische oncologie, Dokter Van Heeweg 2
  • Poland
      • Gdynia, Poland, 81-519
        • Szpitale Pomorskie Sp. z o.o. Oddzial Onkologii i Radioterapii
      • Krakow, Poland, 31-531
        • SP ZOZ Szpital Uniwersytecki w Krakowie Oddzial Kliniczny Onkologii
      • Warszawa, Poland, 02-507
        • Centralny Szpital Kliniczny MSW Klinika Onkologii i Hematologii
      • Warszawa, Poland, 04-125
        • NZOZ MAGODENT Oddzial Onkologii Klinicznej / Chemioterapii
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Russian Cancer Research Center n.a. NN Blokhin
      • Moscow, Russian Federation, 143423
        • Moscow City Oncology Hospital # 62, Chemotherapy
      • Moscow, Russian Federation
        • Russian Cancer Research Center n.a. NN Blokhin, Department of Research for New Antitumour Medicines
      • St Petersburg, Russian Federation, 197758
        • Scientific Centre for Specialized Medical Care (oncological)
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Valle de Hebrón, Servicio de Oncología
      • Cordoba, Spain, 14004
        • Hospital Universitario Reina Sofia, Deparatmento Oncología Médica
      • Hospitalet de Llobregat, Spain, 08908
        • Instituto Catalan De Oncología, Hospitalet de Llobregat
      • Madrid, Spain, 28007
        • Hospital Universitario Gregorio Maranon
      • Madrid, Spain, 28046
        • H. Universitario La Paz Oncología Médica
      • Madrid, Spain, 28034
        • Hospital Ramón y Cajal, Oncología Médica
      • Malaga, Spain, 29010
        • Hospital General Universitario, Oncología Médica
      • Pamplona, Spain, 31008
        • Complejo Hospitalario de Navarra, Oncología Médica
  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
        • The Beatson West of Scotland Cancer Centre GI cancers
      • Leicester, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary, The HOPE Clinical Trials Unit
      • London, United Kingdom, W12 0HS
        • Hammersmith Hospital
      • London, United Kingdom, W6 8RF
        • Imperial Healthcare NHS Trust Charing Cross Hospital
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital NHS Foundation Trust, GI & Endocrine
      • Northwood, United Kingdom, HA6 2RN
        • Mount Vernon Hospital Department of Oncology
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.
  • Coagulation parameters in normal limit (or in therapeutic limit for patients treated with anticoagulant drugs).
  • Women of childbearing potential must have been tested negative in a serum pregnancy test. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control. Women and female partners using hormonal contraceptive must also use a barrier method.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trifluridine/tipiracil + bevacizumab

Trifluridine/tipiracil (S95005): film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride.

Bevacizumab: concentrate for solution for IV infusion containing 25mg/ml of bevacizumab.

Trifluridine/tipiracil was administered at 35 mg/m2/dose orally within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period, with bevacizumab administered intravenously at the dose of 5 mg/kg every 2 weeks at Day 1 and Day 15.This treatment cycle was repeated every 4 weeks.
Drug: Trifluridine/tipiracil + bevacizumab
Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.
Active Comparator: Capecitabine + bevacizumab
Capecitabine was administered at 1250 mg/m² orally BID (bis in die)on Days 1-14 of each cycle, with bevacizumab (7.5 mg/kg, IV) administered on Day 1 of each cycle. This treatment cycle was repeated every 3 weeks
Drug: Capecitabine + bevacizumab
Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
The progression free survival (PFS), defined as the time from the date of randomisation until the date of the investigator-assessed radiological disease progression or death due to any cause according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progressive disease (PD) was defined at least a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) and an absolute increase of at least 5 mm in the sum of lesions or the appearance of new lesions.
Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
As per RECIST v1.1, Complete Response (CR) was disappearance of all target lesions; Partial Response (PR) was at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The ORR was the proportion of patients who presented CR or PR with confirmation at subsequent time point or at least 4 weeks later.
Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
Duration of Response (DR)
Time Frame: Baseline and every 8 weeks (maximum follow-up duration: 16.6 months)
The DR was calculated among patients with CR or PR as the time (months) from the first documentation of response to the first documentation of objective tumor progression or death due to any cause, whichever occurred first.
Baseline and every 8 weeks (maximum follow-up duration: 16.6 months)
Disease Control Rate (DCR)
Time Frame: Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
DCR was the proportion of patients with confirmed CR, PR or stable disease (SD) as best overall response. SD defined as neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD.
Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
Overall Survival (OS)
Time Frame: Baseline up to death or study cut-off (maximum follow-up duration: 19.9 months)
The OS was defined as the time from the date of randomisation to the date of death. If death was not confirmed, or patient was alive at study cut-off date, survival time was censored at the date of last follow-up or at the study cut-off date, whichever was earlier.
Baseline up to death or study cut-off (maximum follow-up duration: 19.9 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Recherches Internationales Servier

Collaborators

ADIR, a Servier Group company

Investigators

  • Principal Investigator: Eric Van Custem, Prof, Leuven Cancer Institute, University Hospitals Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2016

Primary Completion (Actual)

January 15, 2018

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

February 24, 2016

First Submitted That Met QC Criteria

April 14, 2016

First Posted (Estimated)

April 19, 2016

Study Record Updates

Last Update Posted (Actual)

August 20, 2024

Last Update Submitted That Met QC Criteria

July 24, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL2-95005-002
  • 2015-004544-18 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

  • used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
  • where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

  • sponsored by Servier
  • with a first patient enrolled as of 1 January 2004 onwards
  • for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

IPD Sharing Time Frame

After Marketing Authorisation in EEA or US if the study is used for the approval.

IPD Sharing Access Criteria

Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Study Data/Documents

  1. Study Protocol
  2. Statistical Analysis Plan
  3. Informed Consent Form
  4. Clinical Study Report
  5. study-level clinical trial data
  6. Individual Participant Data Set

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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