search
Back to results

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)

Primary Purpose

Metastatic Colorectal Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Trifluridine/Tipiracil hydrochloride (S95005)
Sponsored by
Institut de Recherches Internationales Servier
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Arm Label

S95005

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence of Adverse Events [safety and tolerability]
Abnormalities in laboratory assessment
Abnormalities in performance status (ECOG)
Abnormalities in vital signs

Secondary Outcome Measures

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.
Quality of life using the questionnaire EQ-5D
Quality of life using the questionnaire EORTC QLQ-C30

Full Information

First Posted
August 2, 2017
Last Updated
November 9, 2021
Sponsor
Institut de Recherches Internationales Servier
Collaborators
ADIR, a Servier Group company
search

1. Study Identification

Unique Protocol Identification Number
NCT03306394
Brief Title
A Study of Trifluridine/Tipiracil (Also Known as S 95005 or TAS-102) in Patients With a Pretreated Colorectal Cancer That Has Spread (Metastatic).
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 18, 2016 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Recherches Internationales Servier
Collaborators
ADIR, a Servier Group company

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
metastatic, colorectal, cancer, trifluridine/tipiracil, early access

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
907 (Actual)

8. Arms, Groups, and Interventions

Arm Title
S95005
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Trifluridine/Tipiracil hydrochloride (S95005)
Primary Outcome Measure Information:
Title
Incidence of Adverse Events [safety and tolerability]
Time Frame
Through 28 days following last administration of study medication
Title
Abnormalities in laboratory assessment
Time Frame
Through study completion, an average of 12 weeks
Title
Abnormalities in performance status (ECOG)
Time Frame
Through study completion, an average of 12 weeks
Title
Abnormalities in vital signs
Time Frame
Through study completion, an average of 12 weeks
Secondary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
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.
Time Frame
Through study completion, an average of 12 weeks
Title
Quality of life using the questionnaire EQ-5D
Time Frame
Through study completion, an average of 12 weeks
Title
Quality of life using the questionnaire EORTC QLQ-C30
Time Frame
Through study completion, an average of 12 weeks

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://clinicaltrials.servier.com
Citations:
PubMed Identifier
36040321
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.
Results Reference
derived
PubMed Identifier
33663264
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.
Results Reference
derived
PubMed Identifier
32487542
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.
Results Reference
derived
Links:
URL
https://clinicaltrials.servier.com/wp-content/uploads/CL3-095005-004-laysummary-2021.09.22.pdf.pdf
Description
Lay Summary
URL
https://clinicaltrials.servier.com/wp-content/uploads/CL3-095005-004-anonymisedsynopsis-2021.06.21.pdf.pdf
Description
Results Summary
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://clinicaltrials.servier.com/
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://clinicaltrials.servier.com/
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://clinicaltrials.servier.com/
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://clinicaltrials.servier.com/
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://clinicaltrials.servier.com/
Available IPD/Information Type
study-level clinical trial data
Available IPD/Information URL
https://clinicaltrials.servier.com/

Learn more about this trial

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

We'll reach out to this number within 24 hrs