A Study of Trifluridine/Tipiracil (Also Known as S 95005 or TAS-102) in Patients With a Pretreated Colorectal Cancer That Has Spread (Metastatic). (PRECONNECT)
Metastatic Colorectal Cancer
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring metastatic, colorectal, cancer, trifluridine/tipiracil, early access
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Sites / Locations
- Chris O'Brien Lifehouse Oncology
- St Vincent's Hospital The Kinghorn Cancer Centre
- St Vincent's Hospital (Melbourne) Cancer Centre
- The Canberra Hospital Cancer,Ambulatory & Community Health Service (CACHS) Bldg 19
- Royal Brisbane & Women's Hospital Clinical Research Unit
- Cabrini Hospital Cabrini Haematology and Oncology Centre
- Perth Oncology - Mount Hospital
- The Queen Elizabeth Hospital Haematology and Oncology Unit
- Hôpital Universitaire Erasme Gastro-Entérologie
- Cliniques Universitaires St. Luc Oncologie médicale
- Universitair Ziekenhuis Antwerpen Oncologie
- U.Z. Gent Digestieve Oncologie
- UZ Leuven Campus Gasthuisberg Digestieve Oncologie
- Hospital Mãe de Deus Centro Intergrado de Pesquisa
- Clinicas Oncológicas Integradas (COI)
- AMO Assistencia Multidisciplinar em Oncologia GEM Assistencia Medica Especializada
- Instituto do Cancer do Estado de Sao Paulo - ICESP Núcleo de Pesquisa
- Hospital A C Camargo Unidade de Pesquisa Clínica
- Instituto Brasileiro de Controle do Câncer Unidadde de Pesquisa Clínica
- Complex oncology center - Plovdiv
- Military Medical Academy - MHAT Oncology clinic
- Specialized hospital for active treatment in oncology
- SHAT of oncology diseases
- Klinicki bolnicki centar Rijeka Klinika za radioterapiju i onkologiju
- Klinicki bolnicki centar Zagreb Klinika za onkologiju
- Hopital Privé Les Bonnettes Pharmacie centrale
- Institut Sainte Catherine Institut Sainte Catherine
- Centre de lutte contre le cancer Francois Baclesse UCP Digestif
- Hôpital Trousseau Hépato-gastroentérologie et cancérologie digestive
- CHU Hôpital du Bocage/ François Mitterrand Hépato-gastroentérologie
- CHU de Grenoble Oncologie médicale Hépato-gastroentérologie - 7D
- CHD - Les Oudairies service d'hepato-gastroenterologie
- Franco-British Institue Department of Medical Oncology
- Hopital Privé Jean Mermoz Service de Gastro entérologie et d'Oncologie médicale
- CRLCC Léon Bérard Service d'Oncologie
- CHU de la Timone Hépato-Gastro-Entérologie
- Hôpital Nord Franche-Comté - Site du Mittan Service d'oncologie médicale
- CRLCC Val d'Aurelle Oncologie Médicale
- Centre Antoine Lacassagne Dpt d'Oncologie Médicale
- Hôpital Saint-Antoine Service d'Oncologie Médicale
- Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive
- Groupe Hospitalier Pitié Salpêtrière Service d'hépato-gastro-entérologie
- Hôpital Haut-Lévèque Hépato-gastroentérologie et oncologie digestive
- CHU de Poitiers Pole Régional de Cancérologie
- CHU Robert DEBRE service d'hepato-gastroenterologie / Cancérologie Digestive
- Centre Eugène Marquis Service d'Oncologie Médicale
- Hôpital Nord Pôle Digestif Urologie-Andrologie
- CHU Toulouse Rangueil Oncologie médicale digestive
- Bon Secours Hospital
- The Adelaide and Meath Hospital
- Ist.Tumori "Giovanni Paolo II" IRCCS Osp.Oncologico di Bari U.O.C. di Oncologia Medica
- Fondazione Poliambulanza Istituto Ospedaliero Clinical Oncology
- ARNAS - Azienda Ospedaliera Garibaldi - Nesima Struttura Complessa di Oncologia Medica
- Azienda Ospedaliero-Universitaria Careggi Struttura Complessa Oncologia Medica
- Ist.Scientifico Romagnolo per lo Studio e la Cura dei Tumori Department of Clinical Oncology
- Fondazione IRCCS Istituto Nazionale dei Tumori S.S. Oncologia Medica Gastrenterologia
- A.O.U. Seconda Università degli Studi di Napoli U.O.C. di Oncologia Medica e di Ematologia
- Istituto Oncologico Veneto IOV - IRCCS Unità Operativa Complessa Oncologia Medica 1
- Azienda Ospedaliera "Civico-Di Cristina" - Ospedale Civico Oncologia Medica
- Ospedale Civile Santo Spirito Struttura Complessa di Oncologia Medica
- A.O.U. Pisana-Ospedale Santa Chiara U.O. di Oncologia Medica 2
- Arcispedale Santa Maria Nuova Unità di Oncologia
- Ospedale INFERMI Reparto di Oncologia
- Policlinico Universitario Campus Biomedico UOC di Oncologia Medica
- Policlinico Universitario Agostino Gemelli U.O.C. di Oncologia Medica
- Istituto Clinico Humanitas I.R.C.C.S Dipartimento di Oncologia Medica ed Ematologia
- IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia
- A.O.U. Città della Salute e della Scienza di Torino S.C. Oncologia Medica 1 - Colo-Rectal Cancer Unit
- Centro Hemato-Oncologico de Panama
- Bialostockie Centrum Onkologii im Marii Curie-Sklodowskiej Oddzial Onkologii Klinicznej im Dr Ewy Pileckiej z pododdzialem Chemioterapii Dziennej
- Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii
- Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej
- Wielkopolskie Centrum Onkologii im Marii Sklodowskiej-Curie Oddzial Chemioterapii
- Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Klinika Gastroenterologii Onkologicznej
- Magodent Sp. z o.o.
- Hospital Garcia de Orta Serviço de Oncologia Médica
- Centro Hospitalar e Universitário de Comibra E.P.E. Serviço de Oncologia Médica
- Instituto Português de Oncologia de Coimbra Serviço de Oncologia Médica
- Centro Hospitalar de Lisboa Norte E.P.E. - H. Santa Maria Serviço de Oncologia Médica
- Instituto Português de Oncologia do Porto Serviço de Oncologia Médica
- Centro Hospitalar de São João E.P.E. Serviço de Oncologia
- Spitalul Clinic "Fundeni" Departament Oncologie Medicala - Gastroenterologie
- Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj Napoca Oncologie Medicala
- Institutul Regional de Oncologie Iasi Clinica de Oncologie Medicala
- Onkologicky ustav sv. Alzbety,s.r.o. Interna Klinika VSZ a SP a OUSA
- Vychodoslovensky onkologicky ustav Oddelenie klinickej onkologie
- Onkoloski Institut Ljubljana
- Gazi University Faculty of Medicine Medical Oncology Department
- Hacettepe University Faculty of Medicine
- Uludag University Faculty of Medicine
- Trakya University Faculty of Medicine
- Istanbul University
- Marmara University Pendik Training and Research Hospital
- Ege University Faculty of Medicine Medical Oncology Department
- Erciyes University Mehmet Kemal Dedeman Hematology Oncology
- Kharkiv Regional Oncology Center
- Kyiv City Clinical Oncological Centre Day care facility
- Clinical and diagn.Centre of Medics-rey Inter. Group LLC - Hospital of Israeli Oncology "LISOD
- Treatment-diagnostic Centre PJSC "House of medicine"
Arms of the Study
Arm 1
Experimental
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.