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Metastatic Colorectal CancerPhase 3PRECONNECTNCT03306394

A Study of Trifluridine/Tipiracil (Also Known as S 95005 or TAS-102) in Patients With a Pretreated Colorectal Cancer That Has Spread (Metastatic).

A Phase 3 study testing Trifluridine/Tipiracil hydrochloride (S95005) in people with Metastatic Colorectal Cancer, run by Institut de Recherches Internationales Servier at 99 sites in 16 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 purpose of this study is to collect additional safety and efficacy data during treatment with trifluridine / tipiracil in patients with a pretreated metastatic colorectal cancer (mCRC). 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 hydrochloride (S95005)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
907 participants
Where
99 sitesin 16 countries
Study dates
18 Oct 2016to 30 Nov 2020
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Male or Female participant aged ≥18 years old.
  • Has definitive histologically confirmed adenocarcinoma of the colon or rectum.
  • Has metastatic lesion(s).
  • Has received at least 2 prior regimens of standard chemotherapies (including fluoropyrimidines, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and at least one of the anti-EGFR monoclonal antibodies for RAS wild-type patients) for mCRC and is refractory or intolerant to those chemotherapies or is not candidate for those chemotherapies.
  • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 during the screening period.
  • Is able to take medications orally (i.e., no feeding tube).
  • Has adequate organ function.
  • Women of childbearing potential must have been tested negative in a serum pregnancy test within 7 days prior to first day of test drug administration. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control during the study and for 6 months after the discontinuation of study medication. Women and female partners using hormonal contraceptive must also use a barrier method.

Who cannot join

  • Pregnancy, breastfeeding or possibility of becoming pregnant during the study.
  • Eligible for enrolment into another available ongoing clinical study of trifluridine / tipiracil.
  • Has previously received trifluridine / tipiracil or hypersensitivity to the active substances or to any of the excipients of trifluridine / tipiracil.
  • Has rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption.
  • Has certain serious illness or medical condition(s) described in the protocol.
  • Has had certain other recent treatment e.g. major surgery, anticancer therapy, radiation therapy, participation in another interventional study, within the specified time frames prior to first day of study drug administration.
  • Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation, and platinum-induced neurotoxicity).

Trial locations and contacts

99 sites in 16 countries.

99 sites in 16 countries

France23 sites

  • Hopital Privé Les Bonnettes Pharmacie centrale

    Arras, 62000

  • Institut Sainte Catherine Institut Sainte Catherine

    Avignon, 84918

  • Centre de lutte contre le cancer Francois Baclesse UCP Digestif

    Caen, 14076

  • Hôpital Trousseau Hépato-gastroentérologie et cancérologie digestive

    Chambray-lès-Tours, 37044

  • CHU Hôpital du Bocage/ François Mitterrand Hépato-gastroentérologie

    Dijon, 21079

  • CHU de Grenoble Oncologie médicale Hépato-gastroentérologie - 7D

    Grenoble, 38043

  • CHD - Les Oudairies service d'hepato-gastroenterologie

    La Roche-sur-Yon, 85925

  • Franco-British Institue Department of Medical Oncology

    Levallois-Perret, 92300

  • Hopital Privé Jean Mermoz Service de Gastro entérologie et d'Oncologie médicale

    Lyon, 69008

  • CRLCC Léon Bérard Service d'Oncologie

    Lyon, 69373

  • CHU de la Timone Hépato-Gastro-Entérologie

    Marseille, 13005

  • Hôpital Nord Franche-Comté - Site du Mittan Service d'oncologie médicale

    Montbéliard, 25209

  • CRLCC Val d'Aurelle Oncologie Médicale

    Montpellier, 34298

  • Centre Antoine Lacassagne Dpt d'Oncologie Médicale

    Nice, 06189

  • Hôpital Saint-Antoine Service d'Oncologie Médicale

    Paris, 75012

  • Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive

    Paris, 75015

  • Groupe Hospitalier Pitié Salpêtrière Service d'hépato-gastro-entérologie

    Paris, 75651

  • Hôpital Haut-Lévèque Hépato-gastroentérologie et oncologie digestive

    Pessac, 33604

  • CHU de Poitiers Pole Régional de Cancérologie

    Poitiers, 86021

  • CHU Robert DEBRE service d'hepato-gastroenterologie / Cancérologie Digestive

    Reims, 51100

  • Centre Eugène Marquis Service d'Oncologie Médicale

    Rennes, 35042

  • Hôpital Nord Pôle Digestif Urologie-Andrologie

    Saint-Etienne, 42055

  • CHU Toulouse Rangueil Oncologie médicale digestive

    Toulouse, 31059

Other trials in France

Italy18 sites

  • Ist.Tumori "Giovanni Paolo II" IRCCS Osp.Oncologico di Bari U.O.C. di Oncologia Medica

    Bari, 70124

  • Fondazione Poliambulanza Istituto Ospedaliero Clinical Oncology

    Brescia, 25124

  • ARNAS - Azienda Ospedaliera Garibaldi - Nesima Struttura Complessa di Oncologia Medica

    Catania, 95122

  • Azienda Ospedaliero-Universitaria Careggi Struttura Complessa Oncologia Medica

    Florence, 50134

  • Ist.Scientifico Romagnolo per lo Studio e la Cura dei Tumori Department of Clinical Oncology

    Meldola, 47014

  • Fondazione IRCCS Istituto Nazionale dei Tumori S.S. Oncologia Medica Gastrenterologia

    Milan, 20133

  • A.O.U. Seconda Università degli Studi di Napoli U.O.C. di Oncologia Medica e di Ematologia

    Naples, 80131

  • Istituto Oncologico Veneto IOV - IRCCS Unità Operativa Complessa Oncologia Medica 1

    Padova, 35128

  • Azienda Ospedaliera "Civico-Di Cristina" - Ospedale Civico Oncologia Medica

    Palermo, 90127

  • Ospedale Civile Santo Spirito Struttura Complessa di Oncologia Medica

    Pescara, 64124

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

    Pisa, 56126

  • Arcispedale Santa Maria Nuova Unità di Oncologia

    Reggio Emilia, 42123

  • Ospedale INFERMI Reparto di Oncologia

    Rimini, 47923

  • Policlinico Universitario Campus Biomedico UOC di Oncologia Medica

    Roma, 00128

  • Policlinico Universitario Agostino Gemelli U.O.C. di Oncologia Medica

    Roma, 00168

  • Istituto Clinico Humanitas I.R.C.C.S Dipartimento di Oncologia Medica ed Ematologia

    Rozzano (MI), 20089

  • IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia

    San Giovanni Rotondo, 71013

  • A.O.U. Città della Salute e della Scienza di Torino S.C. Oncologia Medica 1 - Colo-Rectal Cancer Unit

    Torino, 10126

Other trials in Italy

Australia8 sites

  • Chris O'Brien Lifehouse Oncology

    Camperdown, NSW 2050

  • St Vincent's Hospital The Kinghorn Cancer Centre

    Darlinghurst, 2010

  • St Vincent's Hospital (Melbourne) Cancer Centre

    Fitzroy, 3065

  • The Canberra Hospital Cancer,Ambulatory & Community Health Service (CACHS) Bldg 19

    Garran, 2605

  • Royal Brisbane & Women's Hospital Clinical Research Unit

    Herston, 4029

  • Cabrini Hospital Cabrini Haematology and Oncology Centre

    Malvern, 3144

  • Perth Oncology - Mount Hospital

    Perth, 6000

  • The Queen Elizabeth Hospital Haematology and Oncology Unit

    Woodville, SA 5011

Other trials in Australia

Turkey (Türkiye)8 sites

  • Gazi University Faculty of Medicine Medical Oncology Department

    Ankara

  • Hacettepe University Faculty of Medicine

    Ankara

  • Uludag University Faculty of Medicine

    Bursa, 16059

  • Trakya University Faculty of Medicine

    Edirne, 22030

  • Istanbul University

    Istanbul

  • Marmara University Pendik Training and Research Hospital

    Istanbul

  • Ege University Faculty of Medicine Medical Oncology Department

    Izmir, 36040

  • Erciyes University Mehmet Kemal Dedeman Hematology Oncology

    Kayseri, 38039

Other trials in Turkey (Türkiye)

Brazil6 sites

  • Hospital Mãe de Deus Centro Intergrado de Pesquisa

    Porto Alegre, 90470-340

  • Clinicas Oncológicas Integradas (COI)

    Rio de Janeiro, 22793-080

  • AMO Assistencia Multidisciplinar em Oncologia GEM Assistencia Medica Especializada

    Salvador, 41950-610

  • Instituto do Cancer do Estado de Sao Paulo - ICESP Núcleo de Pesquisa

    São Paulo, 01246-000

  • Hospital A C Camargo Unidade de Pesquisa Clínica

    São Paulo, 01509-900

  • Instituto Brasileiro de Controle do Câncer Unidadde de Pesquisa Clínica

    São Paulo, 03102-002

Other trials in Brazil

Poland6 sites

  • Bialostockie Centrum Onkologii im Marii Curie-Sklodowskiej Oddzial Onkologii Klinicznej im Dr Ewy Pileckiej z pododdzialem Chemioterapii Dziennej

    Bialystok, 15-027

  • Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii

    Gdansk, 80-952

  • Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej

    Opole, 46-020

  • Wielkopolskie Centrum Onkologii im Marii Sklodowskiej-Curie Oddzial Chemioterapii

    Poznan, 61-866

  • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Klinika Gastroenterologii Onkologicznej

    Warsaw, 02-781

  • Magodent Sp. z o.o.

    Warsaw, 04-125

Other trials in Poland

Portugal6 sites

  • Hospital Garcia de Orta Serviço de Oncologia Médica

    Almada, 2805-267

  • Centro Hospitalar e Universitário de Comibra E.P.E. Serviço de Oncologia Médica

    Coimbra, 3000-075

  • Instituto Português de Oncologia de Coimbra Serviço de Oncologia Médica

    Coimbra, 3000-075

  • Centro Hospitalar de Lisboa Norte E.P.E. - H. Santa Maria Serviço de Oncologia Médica

    Lisbon, 1649-035

  • Instituto Português de Oncologia do Porto Serviço de Oncologia Médica

    Porto, 4200-072

  • Centro Hospitalar de São João E.P.E. Serviço de Oncologia

    Porto, 4200-319

Other trials in Portugal

Belgium5 sites

  • Hôpital Universitaire Erasme Gastro-Entérologie

    Brussels, 1070

  • Cliniques Universitaires St. Luc Oncologie médicale

    Brussels, 1200

  • Universitair Ziekenhuis Antwerpen Oncologie

    Edegem, 2650

  • U.Z. Gent Digestieve Oncologie

    Ghent, 9000

  • UZ Leuven Campus Gasthuisberg Digestieve Oncologie

    Leuven, 3000

Other trials in Belgium

Bulgaria4 sites

  • Complex oncology center - Plovdiv

    Plovdiv, 4000

  • Military Medical Academy - MHAT Oncology clinic

    Sofia, 1606

  • Specialized hospital for active treatment in oncology

    Sofia, 1756

  • SHAT of oncology diseases

    Varna, 9000

Other trials in Bulgaria

Ukraine4 sites

  • Kharkiv Regional Oncology Center

    Kharkiv, 61070

  • Kyiv City Clinical Oncological Centre Day care facility

    Kiev, 03115

  • Clinical and diagn.Centre of Medics-rey Inter. Group LLC - Hospital of Israeli Oncology "LISOD

    Kyiv, 08720

  • Treatment-diagnostic Centre PJSC "House of medicine"

    Odesa, 65006

Other trials in Ukraine

Romania3 sites

  • Spitalul Clinic "Fundeni" Departament Oncologie Medicala - Gastroenterologie

    Bucharest, 022328

  • Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj Napoca Oncologie Medicala

    Cluj-Napoca, 400015

  • Institutul Regional de Oncologie Iasi Clinica de Oncologie Medicala

    Iași, 700483

Other trials in Romania

Croatia2 sites

  • Klinicki bolnicki centar Rijeka Klinika za radioterapiju i onkologiju

    Rijeka, 51000

  • Klinicki bolnicki centar Zagreb Klinika za onkologiju

    Zagreb, 10000

Other trials in Croatia

Ireland2 sites

  • Bon Secours Hospital

    Cork, 90

  • The Adelaide and Meath Hospital

    Dublin, 24

Other trials in Ireland

Slovakia2 sites

  • Onkologicky ustav sv. Alzbety,s.r.o. Interna Klinika VSZ a SP a OUSA

    Bratislava, 81250

  • Vychodoslovensky onkologicky ustav Oddelenie klinickej onkologie

    Košice, 04191

Other trials in Slovakia

Panama1 site

  • Centro Hemato-Oncologico de Panama

    Panama City, 0832_00752

Other trials in Panama

Slovenia1 site

  • Onkoloski Institut Ljubljana

    Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: An Open-label Early Access Phase IIIb Study of Trifluridine / Tipiracil (S 95005/TAS-102) in Patients With a Pretreated Metastatic Colorectal Cancer (PRECONNECT)

The purpose of this study is to collect additional safety and efficacy data during treatment with trifluridine / tipiracil in patients with a pretreated metastatic colorectal cancer (mCRC).

Eligible patients may receive an early access to trifluridine / tipiracil through this clinical study until progression of disease, unacceptable toxicity, investigator decision, patient refusal or until market authorization or reimbursement has been granted by the relevant Authority of the country where that patient is treated or until trifluridine / tipiracil is available by a doctor's prescription or can be accessed from another source or Sponsor decision.

Being tested
Trifluridine/Tipiracil hydrochloride (S95005)
Keywords
metastatic, colorectal, cancer, trifluridine/tipiracil, early access
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 hydrochloride (S95005)Drug

Study groups in NCT03306394
Study groupRoleWhat they receive
S95005ExperimentalFilm-coated tablet containing 15 mg of trifluridine and 7.065 mg of tipiracil hydrochloride, or 20 mg of trifluridine and 9.42 mg of tipiracil hydrochloride, taken orally twice a day at the dose of 35 mg/m²/dose. The treatment is given until progression of disease, unacceptable toxicity, investigator decision, patient refusal or until market authorization or reimbursement has been granted by the relevant Authority of the country where that patient is treated or until trifluridine / tipiracil is available by a doctor's prescription or can be accessed from another source or Sponsor decision.
Receives: Drug: Trifluridine/Tipiracil hydrochloride (S95005)

What is being measured

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

  1. Incidence of Adverse Events [safety and tolerability]

    Measured: Through 28 days following last administration of study medication

  2. Abnormalities in laboratory assessment

    Measured: Through study completion, an average of 12 weeks

  3. Abnormalities in performance status (ECOG)

    Measured: Through study completion, an average of 12 weeks

  4. Abnormalities in vital signs

    Measured: Through study completion, an average of 12 weeks

Secondary outcomes (3)

  1. Progression free survival (PFS)

    time from the date of first study drug intake until the date of the investigator-assessed disease progression or death due to any cause whichever occurs first.

    Measured: Through study completion, an average of 12 weeks

  2. Quality of life using the questionnaire EQ-5D

    Measured: Through study completion, an average of 12 weeks

  3. Quality of life using the questionnaire EORTC QLQ-C30

    Measured: Through study completion, an average of 12 weeks

Timeline

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

  1. First posted11 Oct 2017
  2. Study start18 Oct 2016
  3. Primary completion30 Nov 2020
  4. Study completion30 Nov 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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
907 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03306394
Sponsor's protocol ID
CL3-95005-004
Other IDs
2016-002311-18, 2016
Acronym
PRECONNECT
Status last verified
Jul 2024
First submitted
2 Aug 2017
Last updated
25 Jul 2024
Results posted
No
Data monitoring committee
No
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

  • Bachet JB, Wyrwicz L, Price T, Cremolini C, Phelip JM, Portales F, Ozet A, Cicin I, Atlan D, Becquart M, Vidot L, Mounedji N, Van Cutsem E, Taieb J, Falcone A. Safety, efficacy and patient-reported outcomes with trifluridine/tipiracil in pretreated metastatic colorectal cancer: results of the PRECONNECT study. ESMO Open. 2020 Jun;5(3):e000698. doi: 10.1136/esmoopen-2020-000698.

    PubMed 32487542

  • Taieb J, Price T, Vidot L, Chevallier B, Wyrwicz L, Bachet JB. Safety and efficacy of trifluridine/tipiracil in previously treated metastatic colorectal cancer: final results from the phase IIIb single-arm PRECONNECT study by duration of therapy. BMC Cancer. 2023 Jan 27;23(1):94. doi: 10.1186/s12885-022-10489-4.

    PubMed 36707808

  • Ozet A, Dane F, Aykan NF, Yalcin S, Evrensel T, Ozkan M, Karabulut B, Ormeci MN, Atasev O, Vidot L, Cicin I. Safety and efficacy of trifluridine/tipiracil in previously treated metastatic colorectal cancer: PRECONNECT Turkey. Future Oncol. 2022 Sep;18(29):3267-3276. doi: 10.2217/fon-2022-0455. Epub 2022 Aug 30.

    PubMed 36040321

  • Zaniboni A, Barone CA, Banzi MC, Bergamo F, Blasi L, Bordonaro R, Bartolomeo MD, Costanzo FD, Frassineti GL, Garufi C, Giuliani F, Latiano TP, Martinelli E, Personeni N, Racca P, Tamburini E, Tonini G, Besse MG, Spione M, Falcone A. Italian results of the PRECONNECT study: safety and efficacy of trifluridine/tipiracil in metastatic colorectal cancer. Future Oncol. 2021 Jun;17(18):2315-2324. doi: 10.2217/fon-2020-1278. Epub 2021 Mar 5.

    PubMed 33663264

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trifluridine/Tipiracil hydrochloride (S95005) in people with Metastatic Colorectal Cancer, run by Institut de Recherches Internationales Servier at 99 sites in 16 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 8 inclusion and 7 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 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in France, Italy, Australia, Turkey (Türkiye), Brazil and 11 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence of Adverse Events [safety and tolerability] (time frame: Through 28 days following last administration of study medication). The study lists 4 primary outcomes in all. 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 NCT03306394, which also lists 4 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 25 Jul 2024.

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