Clinical trial NCT03306394: A Study of Trifluridine/Tipiracil (Also Known as S 95005 or TAS-102) in Patients With a Pretreated Colorectal Cancer That Has Spread (Metastatic).
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metastatic Colorectal Cancer
Keywords: metastatic
colorectal
cancer
trifluridine/tipiracil
early access
Lead sponsor: Servier
Sponsor class: INDUSTRY
Collaborators: name: ADIR, a Servier Group company
First posted: 2017-10-11
Enrollment: 907
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Incidence of Adverse Events [safety and tolerability]
timeFrame: Through 28 days following last administration of study medication
measure: Abnormalities in laboratory assessment
timeFrame: Through study completion, an average of 12 weeks
measure: Abnormalities in performance status (ECOG)
timeFrame: Through study completion, an average of 12 weeks
measure: Abnormalities in vital signs
timeFrame: Through study completion, an average of 12 weeks
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: Through study completion, an average of 12 weeks
measure: Quality of life using the questionnaire EQ-5D
timeFrame: Through study completion, an average of 12 weeks
measure: Quality of life using the questionnaire EORTC QLQ-C30
timeFrame: Through study completion, an average of 12 weeks
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse Oncology
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital The Kinghorn Cancer Centre
city: Fitzroy
country: Australia
facility: St Vincent's Hospital (Melbourne) Cancer Centre
city: Garran
country: Australia
facility: The Canberra Hospital Cancer,Ambulatory & Community Health Service (CACHS) Bldg 19
city: Herston
country: Australia
facility: Royal Brisbane & Women's Hospital Clinical Research Unit
city: Malvern
country: Australia
facility: Cabrini Hospital Cabrini Haematology and Oncology Centre
city: Perth
country: Australia
facility: Perth Oncology - Mount Hospital
city: Woodville
country: Australia
facility: The Queen Elizabeth Hospital Haematology and Oncology Unit
city: Bruxelles
country: Belgium
facility: Hôpital Universitaire Erasme Gastro-Entérologie
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St. Luc Oncologie médicale
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen Oncologie
city: Gent
country: Belgium
facility: U.Z. Gent Digestieve Oncologie
city: Leuven
country: Belgium
facility: UZ Leuven Campus Gasthuisberg Digestieve Oncologie
city: Porto Alegre
country: Brazil
facility: Hospital Mãe de Deus Centro Intergrado de Pesquisa
city: Rio De Janeiro
country: Brazil
facility: Clinicas Oncológicas Integradas (COI)
city: Salvador
country: Brazil
facility: AMO Assistencia Multidisciplinar em Oncologia GEM Assistencia Medica Especializada
city: São Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP Núcleo de Pesquisa
city: São Paulo
country: Brazil
facility: Hospital A C Camargo Unidade de Pesquisa Clínica
city: São Paulo
country: Brazil
facility: Instituto Brasileiro de Controle do Câncer Unidadde de Pesquisa Clínica
city: Plovdiv
country: Bulgaria
facility: Complex oncology center - Plovdiv
city: Sofia
country: Bulgaria
facility: Military Medical Academy - MHAT Oncology clinic
city: Sofia
country: Bulgaria
facility: Specialized hospital for active treatment in oncology
city: Varna
country: Bulgaria
facility: SHAT of oncology diseases
city: Rijeka
country: Croatia
facility: Klinicki bolnicki centar Rijeka Klinika za radioterapiju i onkologiju
city: Zagreb
country: Croatia
facility: Klinicki bolnicki centar Zagreb Klinika za onkologiju
city: Arras
country: France
facility: Hopital Privé Les Bonnettes Pharmacie centrale
city: Avignon
country: France
facility: Institut Sainte Catherine Institut Sainte Catherine
city: Caen
country: France
facility: Centre de lutte contre le cancer Francois Baclesse UCP Digestif
city: Chambray Les Tours
country: France
facility: Hôpital Trousseau Hépato-gastroentérologie et cancérologie digestive
city: Dijon
country: France
facility: CHU Hôpital du Bocage/ François Mitterrand Hépato-gastroentérologie
city: Grenoble Cedex 9
country: France
facility: CHU de Grenoble Oncologie médicale Hépato-gastroentérologie - 7D
city: La Roche Sur Yon
country: France
facility: CHD - Les Oudairies service d'hepato-gastroenterologie
city: Levallois Perret
country: France
facility: Franco-British Institue Department of Medical Oncology
city: Lyon
country: France
facility: Hopital Privé Jean Mermoz Service de Gastro entérologie et d'Oncologie médicale
city: Lyon
country: France
facility: CRLCC Léon Bérard Service d'Oncologie
city: Marseille
country: France
facility: CHU de la Timone Hépato-Gastro-Entérologie
city: Montbeliard
country: France
facility: Hôpital Nord Franche-Comté - Site du Mittan Service d'oncologie médicale
city: Montpellier
country: France
facility: CRLCC Val d'Aurelle Oncologie Médicale
city: Nice
country: France
facility: Centre Antoine Lacassagne Dpt d'Oncologie Médicale
city: Paris
country: France
facility: Hôpital Saint-Antoine Service d'Oncologie Médicale
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive
city: Paris
country: France
facility: Groupe Hospitalier Pitié Salpêtrière Service d'hépato-gastro-entérologie
city: Pessac
country: France
facility: Hôpital Haut-Lévèque Hépato-gastroentérologie et oncologie digestive
city: Poitiers
country: France
facility: CHU de Poitiers Pole Régional de Cancérologie
city: Reims
country: France
facility: CHU Robert DEBRE service d'hepato-gastroenterologie / Cancérologie Digestive
city: Rennes
country: France
facility: Centre Eugène Marquis Service d'Oncologie Médicale
city: Saint Etienne
country: France
facility: Hôpital Nord Pôle Digestif Urologie-Andrologie
city: TOULOUSE cedex 9
country: France
facility: CHU Toulouse Rangueil Oncologie médicale digestive
city: Cork
country: Ireland
facility: Bon Secours Hospital
city: Dublin
country: Ireland
facility: The Adelaide and Meath Hospital
city: Bari
country: Italy
facility: Ist.Tumori "Giovanni Paolo II" IRCCS Osp.Oncologico di Bari U.O.C. di Oncologia Medica
city: Brescia
country: Italy
facility: Fondazione Poliambulanza Istituto Ospedaliero Clinical Oncology
city: Catania
country: Italy
facility: ARNAS - Azienda Ospedaliera Garibaldi - Nesima Struttura Complessa di Oncologia Medica
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi Struttura Complessa Oncologia Medica
city: Meldola
country: Italy
facility: Ist.Scientifico Romagnolo per lo Studio e la Cura dei Tumori Department of Clinical Oncology
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori S.S. Oncologia Medica Gastrenterologia
city: Napoli
country: Italy
facility: A.O.U. Seconda Università degli Studi di Napoli U.O.C. di Oncologia Medica e di Ematologia
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IOV - IRCCS Unità Operativa Complessa Oncologia Medica 1
city: Palermo
country: Italy
facility: Azienda Ospedaliera "Civico-Di Cristina" - Ospedale Civico Oncologia Medica
city: Pescara
country: Italy
facility: Ospedale Civile Santo Spirito Struttura Complessa di Oncologia Medica
city: Pisa
country: Italy
facility: A.O.U. Pisana-Ospedale Santa Chiara U.O. di Oncologia Medica 2
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova Unità di Oncologia
city: Rimini
country: Italy
facility: Ospedale INFERMI Reparto di Oncologia
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico UOC di Oncologia Medica
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli U.O.C. di Oncologia Medica
city: Rozzano (mi)
country: Italy
facility: Istituto Clinico Humanitas I.R.C.C.S Dipartimento di Oncologia Medica ed Ematologia
city: San Giovanni Rotondo
country: Italy
facility: IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza di Torino S.C. Oncologia Medica 1 - Colo-Rectal Cancer Unit
city: Panamá
country: Panama
facility: Centro Hemato-Oncologico de Panama
city: Bialystok
country: Poland
facility: Bialostockie Centrum Onkologii im Marii Curie-Sklodowskiej Oddzial Onkologii Klinicznej im Dr Ewy Pileckiej z pododdzialem Chemioterapii Dziennej
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii
city: Opole
country: Poland
facility: Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Onkologii im Marii Sklodowskiej-Curie Oddzial Chemioterapii
city: Warszawa
country: Poland
facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Klinika Gastroenterologii Onkologicznej
city: Warszawa
country: Poland
facility: Magodent Sp. z o.o.
city: Almada
country: Portugal
facility: Hospital Garcia de Orta Serviço de Oncologia Médica
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitário de Comibra E.P.E. Serviço de Oncologia Médica
city: Coimbra
country: Portugal
facility: Instituto Português de Oncologia de Coimbra Serviço de Oncologia Médica
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Norte E.P.E. - H. Santa Maria Serviço de Oncologia Médica
city: Porto
country: Portugal
facility: Instituto Português de Oncologia do Porto Serviço de Oncologia Médica
city: Porto
country: Portugal
facility: Centro Hospitalar de São João E.P.E. Serviço de Oncologia
city: Bucuresti
country: Romania
facility: Spitalul Clinic "Fundeni" Departament Oncologie Medicala - Gastroenterologie
city: Cluj-napoca
country: Romania
facility: Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj Napoca Oncologie Medicala
city: Iasi
country: Romania
facility: Institutul Regional de Oncologie Iasi Clinica de Oncologie Medicala
city: Bratislava
country: Slovakia
facility: Onkologicky ustav sv. Alzbety,s.r.o. Interna Klinika VSZ a SP a OUSA
city: Kosice
country: Slovakia
facility: Vychodoslovensky onkologicky ustav Oddelenie klinickej onkologie
city: Ljubljana
country: Slovenia
facility: Onkoloski Institut Ljubljana
city: Ankara
country: Turkey
facility: Gazi University Faculty of Medicine Medical Oncology Department
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Medicine
city: Bursa
country: Turkey
facility: Uludag University Faculty of Medicine
city: Edirne
country: Turkey
facility: Trakya University Faculty of Medicine
city: Istanbul
country: Turkey
facility: Istanbul University
city: Istanbul
country: Turkey
facility: Marmara University Pendik Training and Research Hospital
city: Izmir
country: Turkey
facility: Ege University Faculty of Medicine Medical Oncology Department
city: Kayseri
country: Turkey
facility: Erciyes University Mehmet Kemal Dedeman Hematology Oncology
city: Kharkiv
country: Ukraine
facility: Kharkiv Regional Oncology Center
city: Kiev
country: Ukraine
facility: Kyiv City Clinical Oncological Centre Day care facility
city: Kyiv
country: Ukraine
facility: Clinical and diagn.Centre of Medics-rey Inter. Group LLC - Hospital of Israeli Oncology "LISOD
city: Odesa
country: Ukraine
facility: Treatment-diagnostic Centre PJSC "House of medicine"
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.