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

Metastatic Colorectal Cancer Clinical Trial

— PRECONNECT  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03306394
• Other study ID #: CL3-95005-004
• Secondary ID: 2016-002311-18
• Status: Completed
• Phase: Phase 3
• Start date: October 18, 2016
• Est. completion date: November 30, 2020

Study information

• Verified date: November 2021
• Source: Servier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 907
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• Trifluridine/Tipiracil hydrochloride (S95005)

Locations

Country	Name	City	State
Australia	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
Belgium	Cliniques Universitaires St. Luc Oncologie médicale	Bruxelles
Belgium	Hôpital Universitaire Erasme Gastro-Entérologie	Bruxelles
Belgium	Universitair Ziekenhuis Antwerpen Oncologie	Edegem
Belgium	U.Z. Gent Digestieve Oncologie	Gent
Belgium	UZ Leuven Campus Gasthuisberg Digestieve Oncologie	Leuven
Brazil	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	Hospital A C Camargo Unidade de Pesquisa Clínica	São Paulo
Brazil	Instituto Brasileiro de Controle do Câncer Unidadde de Pesquisa Clínica	São Paulo
Brazil	Instituto do Cancer do Estado de Sao Paulo - ICESP Núcleo de Pesquisa	São Paulo
Bulgaria	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
Croatia	Klinicki bolnicki centar Rijeka Klinika za radioterapiju i onkologiju	Rijeka
Croatia	Klinicki bolnicki centar Zagreb Klinika za onkologiju	Zagreb
France	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 Les Tours
France	CHU Hôpital du Bocage/ François Mitterrand Hépato-gastroentérologie	Dijon
France	CHU de Grenoble Oncologie médicale Hépato-gastroentérologie - 7D	Grenoble Cedex 9
France	CHD - Les Oudairies service d'hepato-gastroenterologie	La Roche Sur Yon
France	Franco-British Institue Department of Medical Oncology	Levallois Perret
France	CRLCC Léon Bérard Service d'Oncologie	Lyon
France	Hopital Privé Jean Mermoz Service de Gastro entérologie et d'Oncologie médicale	Lyon
France	CHU de la Timone Hépato-Gastro-Entérologie	Marseille
France	Hôpital Nord Franche-Comté - Site du Mittan Service d'oncologie médicale	Montbeliard
France	CRLCC Val d'Aurelle Oncologie Médicale	Montpellier
France	Centre Antoine Lacassagne Dpt d'Oncologie Médicale	Nice
France	Groupe Hospitalier Pitié Salpêtrière Service d'hépato-gastro-entérologie	Paris
France	Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive	Paris
France	Hôpital Saint-Antoine Service d'Oncologie Médicale	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 cedex 9
Ireland	Bon Secours Hospital	Cork
Ireland	The Adelaide and Meath Hospital	Dublin
Italy	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	Firenze
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	Milano
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	Padova
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 Agostino Gemelli U.O.C. di Oncologia Medica	Roma
Italy	Policlinico Universitario Campus Biomedico UOC 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
Panama	Centro Hemato-Oncologico de Panama	Panamá
Poland	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	Warszawa
Poland	Magodent Sp. z o.o.	Warszawa
Portugal	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	Lisboa
Portugal	Centro Hospitalar de São João E.P.E. Serviço de Oncologia	Porto
Portugal	Instituto Português de Oncologia do Porto Serviço de Oncologia Médica	Porto
Romania	Spitalul Clinic "Fundeni" Departament Oncologie Medicala - Gastroenterologie	Bucuresti
Romania	Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj Napoca Oncologie Medicala	Cluj-napoca
Romania	Institutul Regional de Oncologie Iasi Clinica de Oncologie Medicala	Iasi
Slovakia	Onkologicky ustav sv. Alzbety,s.r.o. Interna Klinika VSZ a SP a OUSA	Bratislava
Slovakia	Vychodoslovensky onkologicky ustav Oddelenie klinickej onkologie	Kosice
Slovenia	Onkoloski Institut Ljubljana	Ljubljana
Turkey	Gazi University Faculty of Medicine Medical Oncology Department	Ankara
Turkey	Hacettepe University Faculty of Medicine	Ankara
Turkey	Uludag University Faculty of Medicine	Bursa
Turkey	Trakya University Faculty of Medicine	Edirne
Turkey	Istanbul University	Istanbul
Turkey	Marmara University Pendik Training and Research Hospital	Istanbul
Turkey	Ege University Faculty of Medicine Medical Oncology Department	Izmir
Turkey	Erciyes University Mehmet Kemal Dedeman Hematology Oncology	Kayseri
Ukraine	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

Sponsors (2)

Lead Sponsor	Collaborator
Institut de Recherches Internationales Servier	ADIR, a Servier Group company

Countries where clinical trial is conducted

Australia,  Belgium,  Brazil,  Bulgaria,  Croatia,  France,  Ireland,  Italy,  Panama,  Poland,  Portugal,  Romania,  Slovakia,  Slovenia,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events [safety and tolerability]		Through 28 days following last administration of study medication
Primary	Abnormalities in laboratory assessment		Through study completion, an average of 12 weeks
Primary	Abnormalities in performance status (ECOG)		Through study completion, an average of 12 weeks
Primary	Abnormalities in vital signs		Through study completion, an average of 12 weeks
Secondary	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.	Through study completion, an average of 12 weeks
Secondary	Quality of life using the questionnaire EQ-5D		Through study completion, an average of 12 weeks
Secondary	Quality of life using the questionnaire EORTC QLQ-C30		Through study completion, an average of 12 weeks

External Links

•   Lay Summary
•   Results Summary