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Metastatic Colorectal CancerPhase 2TASCO1NCT02743221

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

A Phase 2 study testing Trifluridine/tipiracil + bevacizumab and Capecitabine + bevacizumab in people with Metastatic Colorectal Cancer, run by Institut de Recherches Internationales Servier at 57 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Trifluridine/tipiracil + bevacizumab and Capecitabine + bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
57 sitesin 12 countries
Study dates
29 Apr 2016to 1 Sep 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

57 sites in 12 countries.

57 sites in 12 countries

Netherlands9 sites

  • AMC Academisch Medisch Centrum Medische Oncologie

    Amsterdam, 1105 AZ

  • Amphia Ziekenhuis, Interne Geneeskunde/Oncologie, Langendijk 75

    Breda, 4819 EV

  • Catharina Ziekenhuis, Interne Geneeskunde/Oncologie

    Eindhoven, 5623 EJ

  • Martini Ziekenhuizen, Interne Geneeskunde/Oncologie, Van Swietenplein 1

    Groningen, 9728 NT

  • Tergooi Hilversum, Medische Oncologie, Van Riebeeckweg 212

    Hilversum, 1213 XZ

  • Zuyderland Medisch Centrum Interne Geneeskunde

    Sittard, 6162 BG

  • Sint Antonius Ziekenhuis Interne Geneeskunde/Oncologie

    Utrecht, 3543 CX

  • VieCurie Medisch Centrum, Interne Geneeskunde, Tegelseweg 210

    Venlo, 5912 BL

  • Isala Klinieken, Medische oncologie, Dokter Van Heeweg 2

    Zwolle, 8025 AB

Other trials in Netherlands

Spain8 sites

  • Hospital Valle de Hebrón, Servicio de Oncología

    Barcelona, 08035

  • Hospital Universitario Reina Sofia, Deparatmento Oncología Médica

    Córdoba, 14004

  • Instituto Catalan De Oncología, Hospitalet de Llobregat

    L'Hospitalet de Llobregat, 08908

  • Hospital Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Ramón y Cajal, Oncología Médica

    Madrid, 28034

  • H. Universitario La Paz Oncología Médica

    Madrid, 28046

  • Hospital General Universitario, Oncología Médica

    Málaga, 29010

  • Complejo Hospitalario de Navarra, Oncología Médica

    Pamplona, 31008

Other trials in Spain

United Kingdom7 sites

  • The Beatson West of Scotland Cancer Centre GI cancers

    Glasgow, G12 0YN

  • Leicester Royal Infirmary, The HOPE Clinical Trials Unit

    Leicester, LE1 5WW

  • Hammersmith Hospital

    London, W12 0HS

  • Imperial healthcare NHS Trust Charing Cross Hospital

    London, W6 8RF

  • Christie Hospital NHS Foundation Trust, GI & Endocrine

    Manchester, M20 4BX

  • Mount Vernon Hospital Department of Oncology

    Northwood, HA6 2RN

  • Southampton General Hospital

    Southampton, SO16 6YD

Other trials in United Kingdom

Brazil5 sites

  • Hospital do Câncer de Barretos - Fundação Pio XII

    Barretos, 14784-400

  • Centro de Pesquisa Hospital de Caridade de Ijuí

    Ijuí, 98700-000

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

    Rio de Janeiro, 20230-130

  • Hospital de Base, Centro Intergrado de Pesquisa

    São José do Rio Preto, 15090-000

  • Instituto do Câncer do Estado de São Paulo - ICESP, Núcleo de Pesquisa

    São Paulo, 01246-000

Other trials in Brazil

Italy5 sites

  • Fondazione Poliambulanza Istituto Ospedaliero, Clinical Oncology

    Brescia, 25124

  • A.O.U. SanMartino-IST, Unità Operativa Oncologia Medica 1

    Genova, 16132

  • A.O. Ospedale Niguarda Ca' Granda-Milano, Department of Onco-Haematology- Onoclogia Falck

    Milan, 20162

  • Seconda Università degli Studi di Napoli, U.O.C. di Oncologia Medica ed Ematologia

    Naples, 80131

  • .O.U. Pisana-Ospedale Santa Chiara, U.O. di Oncologia Medica 2

    Pisa, 56126

Other trials in Italy

Australia4 sites

  • Chris O'Brien Lifehouse Oncology

    Camperdown, NSW 2050

  • Austin Hospital Olivia Newton-John Cancer & Wellness Centre

    Heidelberg, VIC 3084

  • Western Health, Sunshine Hospital

    Saint Albans, VIC 3021

  • The Queen Elizabeth Hospital Haematology and Oncology Unit

    Woodville, SA 5011

Other trials in Australia

Poland4 sites

  • Szpitale Pomorskie Sp. z o.o. Oddzial Onkologii i Radioterapii

    Gdynia, 81-519

  • SP ZOZ Szpital Uniwersytecki w Krakowie Oddzial Kliniczny Onkologii

    Krakow, 31-531

  • Centralny Szpital Kliniczny MSW Klinika Onkologii i Hematologii

    Warsaw, 02-507

  • NZOZ MAGODENT Oddzial Onkologii Klinicznej / Chemioterapii

    Warsaw, 04-125

Other trials in Poland

Russia4 sites

  • Russian Cancer Research Center n.a. NN Blokhin

    Moscow, 115478

  • Moscow City Oncology Hospital # 62, Chemotherapy

    Moscow, 143423

  • Russian Cancer Research Center n.a. NN Blokhin, Department of Research for New Antitumour Medicines

    Moscow

  • Scientific Centre for Specialized Medical Care (oncological)

    Saint Petersburg, 197758

Other trials in Russia

Belgium3 sites

  • Grand Hôpital de Charleroi Oncologie-Hématologie

    Charleroi, 6000

  • UZ Leuven Campus Gasthuisberg Digestieve Oncologie

    Leuven, 3000

  • CHC Saint-Joseph Oncologie-Hématoimmunopathologie

    Liège, 4000

Other trials in Belgium

France3 sites

  • CHU Jean Minjoz, Service d'oncologie médicale

    Besançon, 25030

  • Hôpital Saint Antoine, oncology department

    Paris, 75012

  • Centre René Gauducheau, Oncologie Médicale

    Saint-Herblain, 44805

Other trials in France

Germany3 sites

  • Onkologische Schwerpunktpraxis Kurfürstendamm

    Berlin, 10707

  • Schwerpunktpraxis für Hämatologie und Onkologie

    Magdeburg, 39104

  • Städtisches Krankenhaus München Neuperlach, Klinik für Onkologie und Hämatologie

    Munich, 81737

Other trials in Germany

Denmark2 sites

  • Rigshospitalet - Dpt of Oncology

    Copenhagen, 2100

  • Odense Universitetshospital - Department of Oncology

    Odense, 5000

Other trials in Denmark

About this study

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).

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.

Being tested
Trifluridine/tipiracil + bevacizumab, Capecitabine + bevacizumab
Keywords
metastatic, colorectal, cancer, untreated, first-line, S95005 (Trifluridine/tipiracil), bevacizumab, capecitabine
Medical subject headings
Colorectal Neoplasms, Neoplasm Metastasis, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trifluridine/tipiracil + bevacizumabDrug

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

  • Capecitabine + bevacizumabDrug

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

Study groups in NCT02743221
Study groupRoleWhat they receive
Trifluridine/tipiracil + bevacizumabExperimentalTrifluridine/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.
Receives: Drug: Trifluridine/tipiracil + bevacizumab
Capecitabine + bevacizumabActive comparatorCapecitabine 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
Receives: Drug: Capecitabine + bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    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.

    Measured: Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)

Secondary outcomes (4)

  1. Overall Response Rate (ORR)

    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.

    Measured: Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)

  2. Duration of Response (DR)

    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.

    Measured: Baseline and every 8 weeks (maximum follow-up duration: 16.6 months)

  3. Disease Control Rate (DCR)

    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.

    Measured: Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)

  4. Overall Survival (OS)

    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.

    Measured: Baseline up to death or study cut-off (maximum follow-up duration: 19.9 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2016 (estimated)
  2. Study start29 Apr 2016
  3. Primary completion15 Jan 2018
  4. Study completion1 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02743221
Sponsor's protocol ID
CL2-95005-002
Other IDs
2015-004544-18, 2015
Acronym
TASCO1
Status last verified
Jul 2024
First submitted
24 Feb 2016
Last updated
20 Aug 2024
Data monitoring committee
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Van Cutsem E, Danielewicz I, Saunders MP, Pfeiffer P, Argiles G, Borg C, Glynne-Jones R, Punt CJA, Van de Wouw AJ, Fedyanin M, Stroyakovskiy D, Kroening H, Garcia-Alfonso P, Wasan H, Falcone A, Fougeray R, Egorov A, Amellal N, Moiseyenko V. First-line trifluridine/tipiracil + bevacizumab in patients with unresectable metastatic colorectal cancer: final survival analysis in the TASCO1 study. Br J Cancer. 2022 Jun;126(11):1548-1554. doi: 10.1038/s41416-022-01737-2. Epub 2022 Apr 19.

    PubMed 35440667

  • Van Cutsem E, Danielewicz I, Saunders MP, Pfeiffer P, Argiles G, Borg C, Glynne-Jones R, Punt CJA, Van de Wouw AJ, Fedyanin M, Stroyakovskiy D, Kroening H, Garcia-Alfonso P, Wasan H, Falcone A, Kanehisa A, Egorov A, Aubel P, Amellal N, Moiseenko V. Trifluridine/tipiracil plus bevacizumab in patients with untreated metastatic colorectal cancer ineligible for intensive therapy: the randomized TASCO1 study. Ann Oncol. 2020 Sep;31(9):1160-1168. doi: 10.1016/j.annonc.2020.05.024. Epub 2020 Jun 1.

    PubMed 32497736

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trifluridine/tipiracil + bevacizumab and Capecitabine + bevacizumab in people with Metastatic Colorectal Cancer, run by Institut de Recherches Internationales Servier at 57 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in Netherlands, Spain, United Kingdom, Brazil, Italy and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02743221, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.

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