A Study of Trifluridine/Tipiracil (Also Known as S 95005 or TAS-102) in Patients With a Pretreated Colorectal Cancer That Has Spread (Metastatic).
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Drug: Trifluridine/Tipiracil hydrochloride (S95005)
- Registration Number
- NCT03306394
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief 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).
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 907
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description S95005 Trifluridine/Tipiracil hydrochloride (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.
- Primary Outcome Measures
Name Time Method Abnormalities in laboratory assessment Through study completion, an average of 12 weeks Incidence of Adverse Events [safety and tolerability] Through 28 days following last administration of study medication Abnormalities in vital signs Through study completion, an average of 12 weeks Abnormalities in performance status (ECOG) Through study completion, an average of 12 weeks
- Secondary Outcome Measures
Name Time Method Quality of life using the questionnaire EORTC QLQ-C30 Through study completion, an average of 12 weeks Progression free survival (PFS) Through study completion, an average of 12 weeks 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.
Quality of life using the questionnaire EQ-5D Through study completion, an average of 12 weeks
Trial Locations
- Locations (99)
Cliniques Universitaires St. Luc Oncologie médicale
🇧🇪Bruxelles, Belgium
Klinicki bolnicki centar Zagreb Klinika za onkologiju
🇭🇷Zagreb, Croatia
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Klinika Gastroenterologii Onkologicznej
🇵🇱Warszawa, Poland
Centro Hospitalar e Universitário de Comibra E.P.E. Serviço de Oncologia Médica
🇵🇹Coimbra, Portugal
Klinicki bolnicki centar Rijeka Klinika za radioterapiju i onkologiju
🇭🇷Rijeka, Croatia
Hospital Garcia de Orta Serviço de Oncologia Médica
🇵🇹Almada, Portugal
Magodent Sp. z o.o.
🇵🇱Warszawa, Poland
Kyiv City Clinical Oncological Centre Day care facility
🇺🇦Kiev, Ukraine
The Adelaide and Meath Hospital
🇮🇪Dublin, Ireland
Centro Hemato-Oncologico de Panama
🇵🇦Panamá, Panama
Vychodoslovensky onkologicky ustav Oddelenie klinickej onkologie
🇸🇰Kosice, Slovakia
Clinical and diagn.Centre of Medics-rey Inter. Group LLC - Hospital of Israeli Oncology "LISOD
🇺🇦Kyiv, Ukraine
Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii
🇵🇱Gdansk, Poland
Wielkopolskie Centrum Onkologii im Marii Sklodowskiej-Curie Oddzial Chemioterapii
🇵🇱Poznan, Poland
Onkologicky ustav sv. Alzbety,s.r.o. Interna Klinika VSZ a SP a OUSA
🇸🇰Bratislava, Slovakia
Treatment-diagnostic Centre PJSC "House of medicine"
🇺🇦Odesa, Ukraine
Chris O'Brien Lifehouse Oncology
🇦🇺Camperdown, Australia
St Vincent's Hospital The Kinghorn Cancer Centre
🇦🇺Darlinghurst, Australia
Royal Brisbane & Women's Hospital Clinical Research Unit
🇦🇺Herston, Australia
Perth Oncology - Mount Hospital
🇦🇺Perth, Australia
Cabrini Hospital Cabrini Haematology and Oncology Centre
🇦🇺Malvern, Australia
Hôpital Universitaire Erasme Gastro-Entérologie
🇧🇪Bruxelles, Belgium
The Queen Elizabeth Hospital Haematology and Oncology Unit
🇦🇺Woodville, Australia
Hospital Mãe de Deus Centro Intergrado de Pesquisa
🇧🇷Porto Alegre, Brazil
UZ Leuven Campus Gasthuisberg Digestieve Oncologie
🇧🇪Leuven, Belgium
U.Z. Gent Digestieve Oncologie
🇧🇪Gent, Belgium
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
Specialized hospital for active treatment in oncology
🇧🇬Sofia, Bulgaria
Institut Sainte Catherine Institut Sainte Catherine
🇫🇷Avignon, France
Hopital Privé Les Bonnettes Pharmacie centrale
🇫🇷Arras, France
CHU Hôpital du Bocage/ François Mitterrand Hépato-gastroentérologie
🇫🇷Dijon, France
CHD - Les Oudairies service d'hepato-gastroenterologie
🇫🇷La Roche Sur Yon, France
CRLCC Léon Bérard Service d'Oncologie
🇫🇷Lyon, France
Hôpital Trousseau Hépato-gastroentérologie et cancérologie digestive
🇫🇷Chambray Les Tours, France
Hopital Privé Jean Mermoz Service de Gastro entérologie et d'Oncologie médicale
🇫🇷Lyon, France
CHU de la Timone Hépato-Gastro-Entérologie
🇫🇷Marseille, France
Franco-British Institue Department of Medical Oncology
🇫🇷Levallois Perret, France
CRLCC Val d'Aurelle Oncologie Médicale
🇫🇷Montpellier, France
Hôpital Nord Franche-Comté - Site du Mittan Service d'oncologie médicale
🇫🇷Montbeliard, France
Groupe Hospitalier Pitié Salpêtrière Service d'hépato-gastro-entérologie
🇫🇷Paris, France
Hôpital Saint-Antoine Service d'Oncologie Médicale
🇫🇷Paris, France
Centre Antoine Lacassagne Dpt d'Oncologie Médicale
🇫🇷Nice, France
Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive
🇫🇷Paris, France
Hôpital Haut-Lévèque Hépato-gastroentérologie et oncologie digestive
🇫🇷Pessac, France
Centre Eugène Marquis Service d'Oncologie Médicale
🇫🇷Rennes, France
Hôpital Nord Pôle Digestif Urologie-Andrologie
🇫🇷Saint Etienne, France
CHU Robert DEBRE service d'hepato-gastroenterologie / Cancérologie Digestive
🇫🇷Reims, France
CHU de Poitiers Pole Régional de Cancérologie
🇫🇷Poitiers, France
Bon Secours Hospital
🇮🇪Cork, 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
Azienda Ospedaliero-Universitaria Careggi Struttura Complessa Oncologia Medica
🇮🇹Firenze, Italy
ARNAS - Azienda Ospedaliera Garibaldi - Nesima Struttura Complessa di Oncologia Medica
🇮🇹Catania, Italy
Ist.Scientifico Romagnolo per lo Studio e la Cura dei Tumori Department of Clinical Oncology
🇮🇹Meldola, Italy
Istituto Oncologico Veneto IOV - IRCCS Unità Operativa Complessa Oncologia Medica 1
🇮🇹Padova, Italy
A.O.U. Seconda Università degli Studi di Napoli U.O.C. di Oncologia Medica e di Ematologia
🇮🇹Napoli, Italy
Azienda Ospedaliera "Civico-Di Cristina" - Ospedale Civico Oncologia Medica
🇮🇹Palermo, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori S.S. Oncologia Medica Gastrenterologia
🇮🇹Milano, 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
IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia
🇮🇹San Giovanni Rotondo, 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
A.O.U. Città della Salute e della Scienza di Torino S.C. Oncologia Medica 1 - Colo-Rectal Cancer Unit
🇮🇹Torino, Italy
Bialostockie Centrum Onkologii im Marii Curie-Sklodowskiej Oddzial Onkologii Klinicznej im Dr Ewy Pileckiej z pododdzialem Chemioterapii Dziennej
🇵🇱Bialystok, Poland
Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej
🇵🇱Opole, Poland
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
🇵🇹Lisboa, 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
🇷🇴Bucuresti, Romania
Institutul Regional de Oncologie Iasi Clinica de Oncologie Medicala
🇷🇴Iasi, Romania
Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj Napoca Oncologie Medicala
🇷🇴Cluj-napoca, Romania
Gazi University Faculty of Medicine Medical Oncology Department
🇹🇷Ankara, Turkey
Hacettepe University Faculty of Medicine
🇹🇷Ankara, Turkey
Onkoloski Institut Ljubljana
🇸🇮Ljubljana, Slovenia
Trakya University Faculty of Medicine
🇹🇷Edirne, Turkey
Uludag University Faculty of Medicine
🇹🇷Bursa, Turkey
Istanbul University
🇹🇷Istanbul, Turkey
Marmara University Pendik Training and Research Hospital
🇹🇷Istanbul, Turkey
Ege University Faculty of Medicine Medical Oncology Department
🇹🇷Izmir, Turkey
Kharkiv Regional Oncology Center
🇺🇦Kharkiv, Ukraine
Erciyes University Mehmet Kemal Dedeman Hematology Oncology
🇹🇷Kayseri, Turkey
Universitair Ziekenhuis Antwerpen Oncologie
🇧🇪Edegem, Belgium
St Vincent's Hospital (Melbourne) Cancer Centre
🇦🇺Fitzroy, Australia
The Canberra Hospital Cancer,Ambulatory & Community Health Service (CACHS) Bldg 19
🇦🇺Garran, Australia
Military Medical Academy - MHAT Oncology clinic
🇧🇬Sofia, Bulgaria
SHAT of oncology diseases
🇧🇬Varna, Bulgaria
Centre de lutte contre le cancer Francois Baclesse UCP Digestif
🇫🇷Caen, France
CHU de Grenoble Oncologie médicale Hépato-gastroentérologie - 7D
🇫🇷Grenoble Cedex 9, France
CHU Toulouse Rangueil Oncologie médicale digestive
🇫🇷TOULOUSE cedex 9, France