Working… Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02743221
Recruitment Status : Active, not recruiting
First Posted : April 19, 2016
Results First Posted : April 16, 2019
Last Update Posted : October 1, 2019
ADIR, a Servier Group company
Information provided by (Responsible Party):
Servier ( Institut de Recherches Internationales Servier )

Brief 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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Trifluridine/tipiracil + bevacizumab Drug: Capecitabine + bevacizumab Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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).
Actual Study Start Date : April 29, 2016
Actual Primary Completion Date : January 15, 2018
Estimated Study Completion Date : April 22, 2020

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02743221

  Hide Study Locations
Layout table for location information
Chris O'Brien Lifehouse Oncology
Camperdown, Australia, NSW 2050
Austin Hospital Olivia Newton-John Cancer & Wellness Centre
Heidelberg, Australia, VIC 3084
Western Health, Sunshine Hospital
Saint Albans, Australia, VIC 3021
The Queen Elizabeth Hospital Haematology and Oncology Unit
Woodville, Australia, SA 5011
Grand Hôpital de Charleroi Oncologie-Hématologie
Charleroi, Belgium, 6000
UZ Leuven Campus Gasthuisberg Digestieve Oncologie
Leuven, Belgium, 3000
CHC Saint-Joseph Oncologie-Hématoimmunopathologie
Liège, Belgium, 4000
Hospital do Câncer de Barretos - Fundação Pio XII
Barretos, Brazil, 14784-400
Centro de Pesquisa Hospital de Caridade de Ijuí
Ijui, Brazil, 98700-000
Instituto Nacional do Câncer - INCA Unidade de Pesquisa ClínicaInstituto Nacional do Câncer - INCA Unidade de Pesquisa Clínica
Rio de Janeiro, Brazil, 20230-130
Hospital de Base, Centro Intergrado de Pesquisa
Sao Jose do Rio Preto, Brazil, 15090-000
Instituto do Câncer do Estado de São Paulo - ICESP, Núcleo de Pesquisa
Sao Paulo, Brazil, 01246-000
Rigshospitalet - Dpt of Oncology
Copenhagen, Denmark, 2100
Odense Universitetshospital - Department of Oncology
Odense, Denmark, 5000
CHU Jean Minjoz, Service d'oncologie médicale
Besançon, France, 25030
Hôpital Saint Antoine, oncology department
Paris, France, 75012
Centre René Gauducheau, Oncologie Médicale
Saint-Herblain, France, 44805
Onkologische Schwerpunktpraxis Kurfürstendamm
Berlin, Germany
Schwerpunktpraxis für Hämatologie und Onkologie
Magdeburg, Germany
Städtisches Krankenhaus München Neuperlach, Klinik für Onkologie und Hämatologie
Munich, Germany
Fondazione Poliambulanza Istituto Ospedaliero, Clinical Oncology
Brescia, Italy, 25124
A.O.U. SanMartino-IST, Unità Operativa Oncologia Medica 1
Genova, Italy, 16132
A.O. Ospedale Niguarda Ca' Granda-Milano, Department of Onco-Haematology- Onoclogia Falck
Milan, Italy, 20162
Seconda Università degli Studi di Napoli, U.O.C. di Oncologia Medica ed Ematologia
Naples, Italy, 80131
.O.U. Pisana-Ospedale Santa Chiara, U.O. di Oncologia Medica 2
Pisa, Italy, 56126
AMC Academisch Medisch Centrum Medische Oncologie
Amsterdam, Netherlands, 1105 AZ
Amphia Ziekenhuis, Interne Geneeskunde/Oncologie, Langendijk 75
Breda, Netherlands, 4819 EV
Catharina Ziekenhuis, Interne Geneeskunde/Oncologie
Eindhoven, Netherlands, 5623 EJ
Martini Ziekenhuizen, Interne Geneeskunde/Oncologie, Van Swietenplein 1
Groningen, Netherlands, 9728 NT
Tergooi Hilversum, Medische Oncologie, Van Riebeeckweg 212
Hilversum, Netherlands, 1213 XZ
Zuyderland Medisch Centrum Interne Geneeskunde
Sittard, Netherlands, 6162 BG
Sint Antonius Ziekenhuis Interne Geneeskunde/Oncologie
Utrecht, Netherlands, 3543 CX
VieCurie Medisch Centrum, Interne Geneeskunde, Tegelseweg 210
Venlo, Netherlands, 5912 BL
Isala Klinieken, Medische oncologie, Dokter Van Heeweg 2
Zwolle, Netherlands, 8025 AB
Szpitale Pomorskie Sp. z o.o. Oddzial Onkologii i Radioterapii
Gdynia, Poland, 81-519
SP ZOZ Szpital Uniwersytecki w Krakowie Oddzial Kliniczny Onkologii
Krakow, Poland, 31-531
Centralny Szpital Kliniczny MSW Klinika Onkologii i Hematologii
Warszawa, Poland, 02-507
NZOZ MAGODENT Oddzial Onkologii Klinicznej / Chemioterapii
Warszawa, Poland, 04-125
Russian Federation
Russian Cancer Research Center n.a. NN Blokhin
Moscow, Russian Federation, 115478
Moscow City Oncology Hospital # 62, Chemotherapy
Moscow, Russian Federation, 143423
Russian Cancer Research Center n.a. NN Blokhin, Department of Research for New Antitumour Medicines
Moscow, Russian Federation
Scientific Centre for Specialized Medical Care (oncological)
St Petersburg, Russian Federation, 197758
Hospital Valle de Hebrón, Servicio de Oncología
Barcelona, Spain, 08035
Hospital Universitario Reina Sofia, Deparatmento Oncología Médica
Cordoba, Spain, 14004
Instituto Catalan De Oncología, Hospitalet de Llobregat
Hospitalet de Llobregat, Spain, 08908
Hospital Universitario Gregorio Maranon
Madrid, Spain, 28009
Hospital Ramón y Cajal, Oncología Médica
Madrid, Spain, 28034
H. Universitario La Paz Oncología Médica
Madrid, Spain, 28046
Hospital General Universitario, Oncología Médica
Malaga, Spain, 28046
Complejo Hospitalario de Navarra, Oncología Médica
Pamplona, Spain, 31008
United Kingdom
The Beatson West of Scotland Cancer Centre GI cancers
Glasgow, United Kingdom, G12 0YN
Leicester Royal Infirmary, The HOPE Clinical Trials Unit
Leicester, United Kingdom, LE1 5WW
Hammersmith Hospital
London, United Kingdom, W12 0HS
Imperial healthcare NHS Trust Charing Cross Hospital
London, United Kingdom, W6 8RF
Christie Hospital NHS Foundation Trust, GI & Endocrine
Manchester, United Kingdom, M20 4BX
Mount Vernon Hospital Department of Oncology
Northwood, United Kingdom, HA6 2RN
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Institut de Recherches Internationales Servier
ADIR, a Servier Group company
Layout table for investigator information
Principal Investigator: Eric Van Custem, Prof Leuven Cancer Institute, University Hospitals Leuven
  Study Documents (Full-Text)

Documents provided by Servier ( Institut de Recherches Internationales Servier ):
Study Protocol  [PDF] January 25, 2017
Statistical Analysis Plan  [PDF] March 21, 2018

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the site

Layout table for additonal information
Responsible Party: Institut de Recherches Internationales Servier Identifier: NCT02743221     History of Changes
Other Study ID Numbers: CL2-95005-002
2015-004544-18 ( EudraCT Number )
First Posted: April 19, 2016    Key Record Dates
Results First Posted: April 16, 2019
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask all interventional clinical studies:

  • submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
  • Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Servier ( Institut de Recherches Internationales Servier ):
S95005 (Trifluridine/tipiracil)
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents