A Study of Trifluridine/Tipiracil (Also Known as S 95005 or TAS-102) in Patients With a Pretreated Colorectal Cancer That Has Spread (Metastatic).
NCT ID: NCT03306394
Last Updated: 2024-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
907 participants
INTERVENTIONAL
2016-10-18
2020-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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S95005
Film-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.
Trifluridine/Tipiracil hydrochloride (S95005)
Interventions
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Trifluridine/Tipiracil hydrochloride (S95005)
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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ADIR, a Servier Group company
INDUSTRY
Institut de Recherches Internationales Servier
OTHER
Responsible Party
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Locations
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Chris O'Brien Lifehouse Oncology
Camperdown, , Australia
St Vincent's Hospital The Kinghorn Cancer Centre
Darlinghurst, , Australia
St Vincent's Hospital (Melbourne) Cancer Centre
Fitzroy, , Australia
The Canberra Hospital Cancer,Ambulatory & Community Health Service (CACHS) Bldg 19
Garran, , Australia
Royal Brisbane & Women's Hospital Clinical Research Unit
Herston, , Australia
Cabrini Hospital Cabrini Haematology and Oncology Centre
Malvern, , Australia
Perth Oncology - Mount Hospital
Perth, , Australia
The Queen Elizabeth Hospital Haematology and Oncology Unit
Woodville, , Australia
Hôpital Universitaire Erasme Gastro-Entérologie
Brussels, , Belgium
Cliniques Universitaires St. Luc Oncologie médicale
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen Oncologie
Edegem, , Belgium
U.Z. Gent Digestieve Oncologie
Ghent, , Belgium
UZ Leuven Campus Gasthuisberg Digestieve Oncologie
Leuven, , Belgium
Hospital Mãe de Deus Centro Intergrado de Pesquisa
Porto Alegre, , Brazil
Clinicas Oncológicas Integradas (COI)
Rio de Janeiro, , Brazil
AMO Assistencia Multidisciplinar em Oncologia GEM Assistencia Medica Especializada
Salvador, , Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP Núcleo de Pesquisa
São Paulo, , Brazil
Hospital A C Camargo Unidade de Pesquisa Clínica
São Paulo, , Brazil
Instituto Brasileiro de Controle do Câncer Unidadde de Pesquisa Clínica
São Paulo, , Brazil
Complex oncology center - Plovdiv
Plovdiv, , Bulgaria
Military Medical Academy - MHAT Oncology clinic
Sofia, , Bulgaria
Specialized hospital for active treatment in oncology
Sofia, , Bulgaria
SHAT of oncology diseases
Varna, , Bulgaria
Klinicki bolnicki centar Rijeka Klinika za radioterapiju i onkologiju
Rijeka, , Croatia
Klinicki bolnicki centar Zagreb Klinika za onkologiju
Zagreb, , Croatia
Hopital Privé Les Bonnettes Pharmacie centrale
Arras, , France
Institut Sainte Catherine Institut Sainte Catherine
Avignon, , France
Centre de lutte contre le cancer Francois Baclesse UCP Digestif
Caen, , France
Hôpital Trousseau Hépato-gastroentérologie et cancérologie digestive
Chambray-lès-Tours, , France
CHU Hôpital du Bocage/ François Mitterrand Hépato-gastroentérologie
Dijon, , France
CHU de Grenoble Oncologie médicale Hépato-gastroentérologie - 7D
Grenoble, , France
CHD - Les Oudairies service d'hepato-gastroenterologie
La Roche-sur-Yon, , France
Franco-British Institue Department of Medical Oncology
Levallois-Perret, , France
Hopital Privé Jean Mermoz Service de Gastro entérologie et d'Oncologie médicale
Lyon, , France
CRLCC Léon Bérard Service d'Oncologie
Lyon, , France
CHU de la Timone Hépato-Gastro-Entérologie
Marseille, , France
Hôpital Nord Franche-Comté - Site du Mittan Service d'oncologie médicale
Montbéliard, , France
CRLCC Val d'Aurelle Oncologie Médicale
Montpellier, , France
Centre Antoine Lacassagne Dpt d'Oncologie Médicale
Nice, , France
Hôpital Saint-Antoine Service d'Oncologie Médicale
Paris, , France
Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive
Paris, , France
Groupe Hospitalier Pitié Salpêtrière Service d'hépato-gastro-entérologie
Paris, , France
Hôpital Haut-Lévèque Hépato-gastroentérologie et oncologie digestive
Pessac, , France
CHU de Poitiers Pole Régional de Cancérologie
Poitiers, , France
CHU Robert DEBRE service d'hepato-gastroenterologie / Cancérologie Digestive
Reims, , France
Centre Eugène Marquis Service d'Oncologie Médicale
Rennes, , France
Hôpital Nord Pôle Digestif Urologie-Andrologie
Saint-Etienne, , France
CHU Toulouse Rangueil Oncologie médicale digestive
Toulouse, , France
Bon Secours Hospital
Cork, , Ireland
The Adelaide and Meath Hospital
Dublin, , Ireland
Ist.Tumori "Giovanni Paolo II" IRCCS Osp.Oncologico di Bari U.O.C. di Oncologia Medica
Bari, , Italy
Fondazione Poliambulanza Istituto Ospedaliero Clinical Oncology
Brescia, , Italy
ARNAS - Azienda Ospedaliera Garibaldi - Nesima Struttura Complessa di Oncologia Medica
Catania, , Italy
Azienda Ospedaliero-Universitaria Careggi Struttura Complessa Oncologia Medica
Florence, , Italy
Ist.Scientifico Romagnolo per lo Studio e la Cura dei Tumori Department of Clinical Oncology
Meldola, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori S.S. Oncologia Medica Gastrenterologia
Milan, , Italy
A.O.U. Seconda Università degli Studi di Napoli U.O.C. di Oncologia Medica e di Ematologia
Napoli, , Italy
Istituto Oncologico Veneto IOV - IRCCS Unità Operativa Complessa Oncologia Medica 1
Padua, , Italy
Azienda Ospedaliera "Civico-Di Cristina" - Ospedale Civico Oncologia Medica
Palermo, , Italy
Ospedale Civile Santo Spirito Struttura Complessa di Oncologia Medica
Pescara, , Italy
A.O.U. Pisana-Ospedale Santa Chiara U.O. di Oncologia Medica 2
Pisa, , Italy
Arcispedale Santa Maria Nuova Unità di Oncologia
Reggio Emilia, , Italy
Ospedale INFERMI Reparto di Oncologia
Rimini, , Italy
Policlinico Universitario Campus Biomedico UOC di Oncologia Medica
Roma, , Italy
Policlinico Universitario Agostino Gemelli U.O.C. di Oncologia Medica
Roma, , Italy
Istituto Clinico Humanitas I.R.C.C.S Dipartimento di Oncologia Medica ed Ematologia
Rozzano (MI), , Italy
IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia
San Giovanni Rotondo, , Italy
A.O.U. Città della Salute e della Scienza di Torino S.C. Oncologia Medica 1 - Colo-Rectal Cancer Unit
Torino, , Italy
Centro Hemato-Oncologico de Panama
Panama City, , Panama
Bialostockie Centrum Onkologii im Marii Curie-Sklodowskiej Oddzial Onkologii Klinicznej im Dr Ewy Pileckiej z pododdzialem Chemioterapii Dziennej
Bialystok, , Poland
Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii
Gdansk, , Poland
Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej
Opole, , Poland
Wielkopolskie Centrum Onkologii im Marii Sklodowskiej-Curie Oddzial Chemioterapii
Poznan, , Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Klinika Gastroenterologii Onkologicznej
Warsaw, , Poland
Magodent Sp. z o.o.
Warsaw, , Poland
Hospital Garcia de Orta Serviço de Oncologia Médica
Almada, , Portugal
Centro Hospitalar e Universitário de Comibra E.P.E. Serviço de Oncologia Médica
Coimbra, , Portugal
Instituto Português de Oncologia de Coimbra Serviço de Oncologia Médica
Coimbra, , Portugal
Centro Hospitalar de Lisboa Norte E.P.E. - H. Santa Maria Serviço de Oncologia Médica
Lisbon, , Portugal
Instituto Português de Oncologia do Porto Serviço de Oncologia Médica
Porto, , Portugal
Centro Hospitalar de São João E.P.E. Serviço de Oncologia
Porto, , Portugal
Spitalul Clinic "Fundeni" Departament Oncologie Medicala - Gastroenterologie
Bucharest, , Romania
Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj Napoca Oncologie Medicala
Cluj-Napoca, , Romania
Institutul Regional de Oncologie Iasi Clinica de Oncologie Medicala
Iași, , Romania
Onkologicky ustav sv. Alzbety,s.r.o. Interna Klinika VSZ a SP a OUSA
Bratislava, , Slovakia
Vychodoslovensky onkologicky ustav Oddelenie klinickej onkologie
Košice, , Slovakia
Onkoloski Institut Ljubljana
Ljubljana, , Slovenia
Gazi University Faculty of Medicine Medical Oncology Department
Ankara, , Turkey (Türkiye)
Hacettepe University Faculty of Medicine
Ankara, , Turkey (Türkiye)
Uludag University Faculty of Medicine
Bursa, , Turkey (Türkiye)
Trakya University Faculty of Medicine
Edirne, , Turkey (Türkiye)
Istanbul University
Istanbul, , Turkey (Türkiye)
Marmara University Pendik Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Ege University Faculty of Medicine Medical Oncology Department
Izmir, , Turkey (Türkiye)
Erciyes University Mehmet Kemal Dedeman Hematology Oncology
Kayseri, , Turkey (Türkiye)
Kharkiv Regional Oncology Center
Kharkiv, , Ukraine
Kyiv City Clinical Oncological Centre Day care facility
Kiev, , Ukraine
Clinical and diagn.Centre of Medics-rey Inter. Group LLC - Hospital of Israeli Oncology "LISOD
Kyiv, , Ukraine
Treatment-diagnostic Centre PJSC "House of medicine"
Odesa, , Ukraine
Countries
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References
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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.
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.
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.
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.
Study Documents
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Document Type: Individual Participant Data Set
View DocumentDocument Type: Study Protocol
View DocumentDocument Type: Statistical Analysis Plan
View DocumentDocument Type: Informed Consent Form
View DocumentDocument Type: Clinical Study Report
View DocumentDocument Type: study-level clinical trial data
View DocumentOther Identifiers
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2016-002311-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CL3-95005-004
Identifier Type: -
Identifier Source: org_study_id
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