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)

November 9, 2021 updated by: Institut de Recherches Internationales Servier

An Open-label Early Access Phase IIIb Study of Trifluridine / Tipiracil (S 95005/TAS-102) in Patients With a Pretreated Metastatic Colorectal Cancer (PRECONNECT)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

907

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Camperdown, Australia, NSW 2050
        • Chris O'Brien Lifehouse Oncology
      • Darlinghurst, Australia, 2010
        • St Vincent's Hospital The Kinghorn Cancer Centre
      • Fitzroy, Australia, 3065
        • St Vincent's Hospital (Melbourne) Cancer Centre
      • Garran, Australia, 2605
        • The Canberra Hospital Cancer,Ambulatory & Community Health Service (CACHS) Bldg 19
      • Herston, Australia, 4029
        • Royal Brisbane & Women's Hospital Clinical Research Unit
      • Malvern, Australia, 3144
        • Cabrini Hospital Cabrini Haematology and Oncology Centre
      • Perth, Australia, 6000
        • Perth Oncology - Mount Hospital
      • Woodville, Australia, SA 5011
        • The Queen Elizabeth Hospital Haematology and Oncology Unit
  • Belgium
      • Bruxelles, Belgium, 1070
        • Hôpital Universitaire Erasme Gastro-Entérologie
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires St. Luc Oncologie médicale
      • Edegem, Belgium, 2650
        • Universitair Ziekenhuis Antwerpen Oncologie
      • Gent, Belgium, 9000
        • U.Z. Gent Digestieve Oncologie
      • Leuven, Belgium, 3000
        • UZ Leuven Campus Gasthuisberg Digestieve Oncologie
  • Brazil
      • Porto Alegre, Brazil, 90470-340
        • Hospital Mãe de Deus Centro Intergrado de Pesquisa
      • Rio De Janeiro, Brazil, 22793-080
        • Clinicas Oncológicas Integradas (COI)
      • Salvador, Brazil, 41950-610
        • AMO Assistencia Multidisciplinar em Oncologia GEM Assistencia Medica Especializada
      • São Paulo, Brazil, 01509-900
        • Hospital A C Camargo Unidade de Pesquisa Clinica
      • São Paulo, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo - ICESP Núcleo de Pesquisa
      • São Paulo, Brazil, 03102-002
        • Instituto Brasileiro de Controle do Câncer Unidadde de Pesquisa Clínica
  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • Complex Oncology Center - Plovdiv
      • Sofia, Bulgaria, 1756
        • Specialized Hospital for Active Treatment in Oncology
      • Sofia, Bulgaria, 1606
        • Military Medical Academy - MHAT Oncology clinic
      • Varna, Bulgaria, 9000
        • SHAT of oncology diseases
  • Croatia
      • Rijeka, Croatia, 51000
        • Klinicki bolnicki centar Rijeka Klinika za radioterapiju i onkologiju
      • Zagreb, Croatia, 10000
        • Klinicki bolnicki centar Zagreb Klinika za onkologiju
  • France
      • Arras, France, 62000
        • Hopital Privé Les Bonnettes Pharmacie centrale
      • Avignon, France, 84918
        • Institut Sainte Catherine Institut Sainte Catherine
      • Caen, France, 14076
        • Centre de lutte contre le cancer Francois Baclesse UCP Digestif
      • Chambray Les Tours, France, 37044
        • Hôpital Trousseau Hépato-gastroentérologie et cancérologie digestive
      • Dijon, France, 21079
        • CHU Hôpital du Bocage/ François Mitterrand Hépato-gastroentérologie
      • Grenoble Cedex 9, France, 38043
        • CHU de Grenoble Oncologie médicale Hépato-gastroentérologie - 7D
      • La Roche Sur Yon, France, 85925
        • CHD - Les Oudairies service d'hepato-gastroenterologie
      • Levallois Perret, France, 92300
        • Franco-British Institue Department of Medical Oncology
      • Lyon, France, 69008
        • Hopital Privé Jean Mermoz Service de Gastro entérologie et d'Oncologie médicale
      • Lyon, France, 69373
        • CRLCC Léon Bérard Service d'Oncologie
      • Marseille, France, 13005
        • CHU de la Timone Hépato-Gastro-Entérologie
      • Montbeliard, France, 25209
        • Hôpital Nord Franche-Comté - Site du Mittan Service d'oncologie médicale
      • Montpellier, France, 34298
        • CRLCC Val d'Aurelle Oncologie Médicale
      • Nice, France, 06189
        • Centre Antoine Lacassagne Dpt d'Oncologie Médicale
      • Paris, France, 75012
        • Hôpital Saint-Antoine Service d'Oncologie Médicale
      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive
      • Paris, France, 75651
        • Groupe Hospitalier Pitié Salpêtrière Service d'hépato-gastro-entérologie
      • Pessac, France, 33604
        • Hopital Haut-Leveque Hepato-gastroenterologie et oncologie digestive
      • Poitiers, France, 86021
        • CHU de Poitiers Pole Régional de Cancérologie
      • Reims, France, 51100
        • CHU Robert DEBRE service d'hepato-gastroenterologie / Cancérologie Digestive
      • Rennes, France, 35042
        • Centre Eugène Marquis Service d'Oncologie Médicale
      • Saint Etienne, France, 42055
        • Hôpital Nord Pôle Digestif Urologie-Andrologie
      • TOULOUSE cedex 9, France, 31059
        • CHU Toulouse Rangueil Oncologie médicale digestive
  • Ireland
      • Cork, Ireland, 90
        • Bon Secours Hospital
      • Dublin, Ireland, 24
        • The Adelaide and Meath Hospital
  • Italy
      • Bari, Italy, 70124
        • Ist.Tumori "Giovanni Paolo II" IRCCS Osp.Oncologico di Bari U.O.C. di Oncologia Medica
      • Brescia, Italy, 25124
        • Fondazione Poliambulanza Istituto Ospedaliero Clinical Oncology
      • Catania, Italy, 95122
        • ARNAS - Azienda Ospedaliera Garibaldi - Nesima Struttura Complessa di Oncologia Medica
      • Firenze, Italy, 50134
        • Azienda Ospedaliero-Universitaria Careggi Struttura Complessa Oncologia Medica
      • Meldola, Italy, 47014
        • Ist.Scientifico Romagnolo per lo Studio e la Cura dei Tumori Department of Clinical Oncology
      • Milano, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori S.S. Oncologia Medica Gastrenterologia
      • Napoli, Italy, 80131
        • A.O.U. Seconda Università degli Studi di Napoli U.O.C. di Oncologia Medica e di Ematologia
      • Padova, Italy, 35128
        • Istituto Oncologico Veneto IOV - IRCCS Unità Operativa Complessa Oncologia Medica 1
      • Palermo, Italy, 90127
        • Azienda Ospedaliera "Civico-Di Cristina" - Ospedale Civico Oncologia Medica
      • Pescara, Italy, 64124
        • Ospedale Civile Santo Spirito Struttura Complessa di Oncologia Medica
      • Pisa, Italy, 56126
        • A.O.U. Pisana-Ospedale Santa Chiara U.O. di Oncologia Medica 2
      • Reggio Emilia, Italy, 42123
        • Arcispedale Santa Maria Nuova Unità di Oncologia
      • Rimini, Italy, 47923
        • Ospedale INFERMI Reparto di Oncologia
      • Roma, Italy, 00128
        • Policlinico Universitario Campus Biomedico UOC di Oncologia Medica
      • Roma, Italy, 00168
        • Policlinico Universitario Agostino Gemelli U.O.C. di Oncologia Medica
      • Rozzano (mi), Italy, 20089
        • Istituto Clinico Humanitas I.R.C.C.S Dipartimento di Oncologia Medica ed Ematologia
      • San Giovanni Rotondo, Italy, 71013
        • IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia
      • Torino, Italy, 10126
        • A.O.U. Città della Salute e della Scienza di Torino S.C. Oncologia Medica 1 - Colo-Rectal Cancer Unit
  • Panama
      • Panamá, Panama, 0832_00752
        • Centro Hemato-Oncologico de Panama
  • Poland
      • Bialystok, Poland, 15-027
        • Bialostockie Centrum Onkologii im Marii Curie-Sklodowskiej Oddzial Onkologii Klinicznej im Dr Ewy Pileckiej z pododdzialem Chemioterapii Dziennej
      • Gdansk, Poland, 80-952
        • Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii
      • Opole, Poland, 46-020
        • Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej
      • Poznan, Poland, 61-866
        • Wielkopolskie Centrum Onkologii im Marii Sklodowskiej-Curie Oddzial Chemioterapii
      • Warszawa, Poland, 02-781
        • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Klinika Gastroenterologii Onkologicznej
      • Warszawa, Poland, 04-125
        • Magodent Sp. Z o.o.
  • Portugal
      • Almada, Portugal, 2805-267
        • Hospital Garcia de Orta Serviço de Oncologia Médica
      • Coimbra, Portugal, 3000-075
        • Centro Hospitalar e Universitário de Comibra E.P.E. Serviço de Oncologia Médica
      • Coimbra, Portugal, 3000-075
        • Instituto Português de Oncologia de Coimbra Serviço de Oncologia Médica
      • Lisboa, Portugal, 1649-035
        • Centro Hospitalar de Lisboa Norte E.P.E. - H. Santa Maria Serviço de Oncologia Médica
      • Porto, Portugal, 4200-072
        • Instituto Português de Oncologia do Porto Serviço de Oncologia Médica
      • Porto, Portugal, 4200-319
        • Centro Hospitalar de São João E.P.E. Serviço de Oncologia
  • Romania
      • Bucuresti, Romania, 022328
        • Spitalul Clinic "Fundeni" Departament Oncologie Medicala - Gastroenterologie
      • Cluj-napoca, Romania, 400015
        • Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj Napoca Oncologie Medicala
      • Iasi, Romania, 700483
        • Institutul Regional de Oncologie Iasi Clinica de Oncologie Medicala
  • Slovakia
      • Bratislava, Slovakia, 81250
        • Onkologicky ustav sv. Alzbety,s.r.o. Interna Klinika VSZ a SP a OUSA
      • Kosice, Slovakia, 04191
        • Vychodoslovensky onkologicky ustav Oddelenie klinickej onkologie
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Onkološki Inštitut Ljubljana
  • Turkey
      • Ankara, Turkey
        • Hacettepe University Faculty of Medicine
      • Ankara, Turkey
        • Gazi University Faculty of Medicine Medical Oncology Department
      • Bursa, Turkey, 16059
        • Uludag University Faculty of Medicine
      • Edirne, Turkey, 22030
        • Trakya University Faculty of Medicine
      • Istanbul, Turkey
        • Istanbul University
      • Istanbul, Turkey
        • Marmara University Pendik Training and Research Hospital
      • Izmir, Turkey, 36040
        • Ege University Faculty of Medicine Medical Oncology Department
      • Kayseri, Turkey, 38039
        • Erciyes University Mehmet Kemal Dedeman Hematology Oncology
  • Ukraine
      • Kharkiv, Ukraine, 61070
        • Kharkiv Regional Oncology Center
      • Kiev, Ukraine, 03115
        • Kyiv City Clinical Oncological Centre Day care facility
      • Kyiv, Ukraine, 08720
        • Clinical and diagn.Centre of Medics-rey Inter. Group LLC - Hospital of Israeli Oncology "LISOD
      • Odesa, Ukraine, 65006
        • Treatment-diagnostic Centre PJSC "House of medicine"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Trifluridine/Tipiracil hydrochloride (S95005)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Adverse Events [safety and tolerability]
Time Frame: Through 28 days following last administration of study medication
Through 28 days following last administration of study medication
Abnormalities in laboratory assessment
Time Frame: Through study completion, an average of 12 weeks
Through study completion, an average of 12 weeks
Abnormalities in performance status (ECOG)
Time Frame: Through study completion, an average of 12 weeks
Through study completion, an average of 12 weeks
Abnormalities in vital signs
Time Frame: Through study completion, an average of 12 weeks
Through study completion, an average of 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: 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.
Through study completion, an average of 12 weeks
Quality of life using the questionnaire EQ-5D
Time Frame: Through study completion, an average of 12 weeks
Through study completion, an average of 12 weeks
Quality of life using the questionnaire EORTC QLQ-C30
Time Frame: Through study completion, an average of 12 weeks
Through study completion, an average of 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Recherches Internationales Servier

Collaborators

ADIR, a Servier Group company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 18, 2016

Primary Completion (ACTUAL)

November 30, 2020

Study Completion (ACTUAL)

November 30, 2020

Study Registration Dates

First Submitted

August 2, 2017

First Submitted That Met QC Criteria

October 4, 2017

First Posted (ACTUAL)

October 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 17, 2021

Last Update Submitted That Met QC Criteria

November 9, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL3-95005-004
  • 2016-002311-18 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

  • used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
  • where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

  • sponsored by Servier
  • with a first patient enrolled as of 1 January 2004 onwards
  • for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

IPD Sharing Time Frame

After Marketing Authorisation in EEA or US if the study is used for the approval.

IPD Sharing Access Criteria

Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Study Data/Documents

  1. Individual Participant Data Set
  2. Study Protocol
  3. Statistical Analysis Plan
  4. Informed Consent Form
  5. Clinical Study Report
  6. study-level clinical trial data

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Locations

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