Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy. (SOLSTICE)

• ClinicalTrials.gov Identifier: NCT03869892
• Recruitment Status: Active, not recruiting
• First Posted: March 11, 2019
• Last Update Posted: September 30, 2020
• Sponsor: Institut de Recherches Internationales Servier
• Collaborator: ADIR, a Servier Group company
• Information provided by (Responsible Party): Servier ( Institut de Recherches Internationales Servier )

Study Description

Brief Summary:

The main purpose of this study is to demonstrate the superiority of S 95005 in combination with bevacizumab over capecitabine in combination with bevacizumab.

Condition or disease	Intervention/treatment	Phase
Metastatic Colorectal Cancer	Drug: Trifluridine/tipiracil hydrochloride (S95005); Drug: Capecitabine; Biological: Bevacizumab experimental; Biological: Bevacizumab control	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 856 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Randomised, Phase III Study cOmparing trifLuridine/Tipiracil (S 95005) in Combination With Bevacizumab to Capecitabine in Combination With Bevacizumab in firST-line Treatment of Patients With metastatIC Colorectal Cancer Who Are Not candidatE for Intensive Therapy (SOLSTICE Study)
• Actual Study Start Date: March 21, 2019
• Estimated Primary Completion Date: September 18, 2022
• Estimated Study Completion Date: September 18, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: S95005 + Bevacizumab	Drug: Trifluridine/tipiracil hydrochloride (S95005); Film-coated tablets of S 95005 (35 mg/m²/dose) will be administered orally twice a day (BID), within 1 hour after completion of morning and evening meals, 5 days on/2 days off, over 2 weeks, followed by a 14-day rest; This treatment cycle will be repeated every 4 weeks.; Biological: Bevacizumab experimental; Concentrate for solution for infusion, Bevacizumab (5 mg/kg, IV) administered every 2 weeks (Day 1 and Day 15). This treatment cycle will be repeated every 4 weeks.
Active Comparator: Capecitabine + Bevacizumab	Drug: Capecitabine; Film-coated tablets, Capecitabine (1250 mg/m²/dose) will be administered orally BID on Days 1-14 of each cycle. This treatment cycle will be repeated every 3 weeks.; Biological: Bevacizumab control; Concentrate for solution for infusion, Bevacizumab (7.5 mg/kg, IV) will be administered on Day 1 of each cycle.This treatment cycle will be repeated every 3 weeks.

Outcome Measures

Primary Outcome Measures :

1. Progression-free Survival (PFS) [ Time Frame: Up to 24 months ]
   Time elapsed between the randomization and the date of radiological tumour progression (according to RECIST 1.1) or death from any cause.

Secondary Outcome Measures :

1. Overall Survival (OS) [ Time Frame: Up to 24 months ]
   Time elapsed between the date of randomization and the date of death due to any cause.
2. Overall response rate (ORR) [ Time Frame: Up to 24 months ]
   The proportion of patients with objective evidence of complete response (CR) or partial response (PR) according to RECIST 1.1 criteria and using investigator's tumour assessment.
3. Disease control rate (DCR) [ Time Frame: Up to 24 months ]
   The proportion of patients with objective evidence of CR or PR or stable disease (SD) according to RECIST 1.1 criteria and using investigator's tumour assessment.
4. Duration of response (DoR) [ Time Frame: Up to 24 months ]
   The time from the first documentation of response (CR or PR) to the first documentation of objective tumour progression or death due to any cause, whichever occurs first.
5. Time to treatment failure (TTF) [ Time Frame: Up to 24 months ]
   The time from randomization to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Has definitive histologically confirmed adenocarcinoma of the colon or rectum (all other histological types are excluded). Primary tumour localisation must be known.
2. RAS status based on local biological assessment of tumour biopsy must be available. If RAS status is not available at the time of randomisation, tumour biopsy must be available for RAS status determination (based on local biological assessment).
3. Patient is not a candidate for standard full dose combination chemotherapy with irinotecan or oxaliplatin
4. Patient is not a candidate for curative resection of metastatic lesions.
5. No previous systemic anticancer therapy for unresectable metastatic colorectal cancer.
6. ECOG (Eastern Cooperative Oncology Group) performance status ≤2.

7. Adequate organ function (renal, haematological, hepatic, coagulation) as described in the study protocol'

   Exclusion Criteria:

8. Pregnancy, breastfeeding or possibility of becoming pregnant during the study.
9. Participation in another interventional study within 4 weeks prior to the randomisation .
10. Patients who have not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy prior to the randomisation.
11. Symptomatic central nervous system metastases.

12. Major surgery within 4 weeks prior to the randomisation.

    Exclusion criteria related to S 95005 administration:

13. History of allergic reactions attributed to compounds of similar composition to S 95005 or any of its excipients.

14. Any contraindication present in the SmPC of trifluridine/tipiracil

    Exclusion criteria related to bevacizumab administration:

15. Any contraindication present in the SmPC of bevacizumab

    Exclusion criteria related to capecitabine administration:

16. Any contraindication present in the SmPC of capecitabine

Contacts and Locations

Locations

Argentina

Centro de Oncología e Investigación de Buenos Aires COIBA

Berazategui, Argentina, B1884BBF

Fundación Favaloro Oncology Unit

Buenos Aires, Argentina, C1093AAS

Instituto Alexander Fleming

Ciudad Autonoma de Buenos aires, Argentina, C1426ANZ

Hospital Universitario CEMIC Servicio de Oncología, Unidad de tumores gastrointestinales

Ciudad Autonoma de Buenos aires, Argentina, C1431FWO

Hospital de Gastroenterología Dr. Carlos Borino Udaondo Oncology Unit

Ciudad Autónoma de Buenos Aires, Argentina, 1264

Centro Oncológico Riojano Integral CORI Fundación CORI para la Investigación y Prevención del Cáncer

La Rioja, Argentina, F5300COE

Fundación COIR Centro Oncológico de Interación Regional

Mendoza, Argentina, 5500

Instituto de Oncología de Rosario

Santa Fe, Argentina, S2000KZE

ISIS Centro especializado

Santa Fe, Argentina, S3000FFU

Centro Médico San Roque

Tucumán, Argentina, T4000IAK

Australia

Blacktown Hospital Cancer and Haematology Centre

Blacktown, Australia, 2148

Frankston Private Peninsula and Southeast Oncology Group

Frankston, Australia, 3199

Lake Macquarie Private Hospital

Gateshead, Australia, 2290

St George Hospital St George Hospital Cancer Care Centre

Kogarah, Australia, 2217

Adventist HealthCare Integrated Cancer Centre

Wahroonga, Australia, 2076

Southern Medical Day Care Centre

Wollongong, Australia, 2500

Austria

Med. Universität Graz Klinische Abteilung für Onkologie

Graz, Austria, 8036

Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin V

Innsbruck, Austria, 6020

Ordensklinikum Linz Barmherzige Schwestern Interne I

Linz, Austria, 4010

Landeskrankenhaus (SALK) Universitätsklinik für Innere Medizin III (SALK)

Salzburg, Austria, 5020

Universitätsklinikum St. Pölten Klinische Abteilung für Innere Medizin I

St. Poelten, Austria, 3100

Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie

Wien, Austria, 1090

Brazil

Hospital do Câncer de Barretos - Fundação Pio XII Unidade de Pesquisa Clínica

Barretos, Brazil, 14784-400

Cenantron - Clinica

Belo Horizonte, Brazil, 30150-320

Sirio Libanes DF - Centro de Oncologia de Braslia do Sirio- Centro Intergrado de Pesquisa

Brasília, Brazil, 70200-730

Centro de Pesquisa Hospital de Caridade de Ijuí Unidade de Pesquisa Clínica

Ijuí, Brazil, 98700-000

Hospital Mae de Deus Oncologia

Porto Alegre, Brazil, 90880-480

Hospital São Rafael Centro Intergrado de Pesquisa

Salvador, Brazil, 41253-191

CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncol Centro Intergrado de Pesquisa

Santo André, Brazil, 09060-870

Hospital de Base Centro Integrado de Pesquisa

São José Do Rio Preto, Brazil, 15090-000

ICESP - Instituto do Câncer do Estado de São Paulo Centro Integrado de Pesquisa

São Paulo, Brazil, 01246-000

Hospital A C Camargo Unidade de Pesquisa Clinica

São Paulo, Brazil, 01509-900

Bulgaria

"Complex oncology center - Burgas" EOOD Department of medical oncology

Burgas, Bulgaria, 8000

"Multiprofile hosp. for active treatmen Dr. Tota Venkova" AD Department of medical oncology

Gabrovo, Bulgaria, 5300

"Complex oncology center - Plovdiv" EOOD, IInd base Dpt. of Med. oncology and onc. diseases in gastroenterology

Plovdiv, Bulgaria, 4004

"Spec. hospital for active treatment of oncology dis." EOOD Department of medical oncology and palliative care

Sofia, Bulgaria, 1233

"Medical Center Nadezhda Clinical" EOOD Medical Oncology Department

Sofia, Bulgaria, 1330

"UMHAT Sv. Ivan Rilski" EAD Clinic of clinical hematology, Dpt. of medical oncology

Sofia, Bulgaria, 1431

MHAT Serdika EOOD Department of Medical Oncology

Sofia, Bulgaria, 1632

Spec. hospital for active treatment of oncology dis. EOOD Department of medical oncology and palliative car

Sofia, Bulgaria, 1756

SHAT of oncology diseases Dr. Marko Antonov Markov" EOOD Department of medical oncology and palliative therapy

Varna, Bulgaria, 9003

"Complex Ongology Center - Vratsa" EOOD Department of Medical oncology

Vratsa, Bulgaria, 3000

Czechia

Masarykuv onkologicky ustav Klinika komplexni onkologicke pece

Brno, Czechia, 656 53

Fakultni nemocnice Ostrava Klinika onkologicka

Ostrava, Czechia

Vseobecna fakultni nemocnice Onkologicka klinika VFN a 1. LF UK

Praha, Czechia, 128 08

Thomayerova nemocnice Onkologicka klinika 1. LF UK a TN

Praha, Czechia, 140 59

Fakultni nemocnice Olomouc Onkologicka klinika

Praha, Czechia, 77900

Denmark

Aalborg Universitetshospital, Syd Onkologisk Afdelin

Aalborg, Denmark, 9000

Regionshospitalet Herning, Hospitalsenheden Vest Onkologisk Afdeling

Herning, Denmark, 7400

Rigshospitalet Onkologisk Klinik

Kobenhavn, Denmark, 2100

Odense Universitetshospital Onkologisk Afdeling R

Odense, Denmark, 5000

Estonia

East Tallinn Central Hospital Center of Oncology

Tallinn, Estonia, 11312

North Estonia Medical Centre Foundation Oncology and Haematology clinic

Tallinn, Estonia, 13419

Tartu University Hospital, Hematology - Oncology clinic, Radiotherapy and oncological therapy

Tartu, Estonia, 51014

France

Institut Sainte Catherine

Avignon, France, 84918

CHU Jean Minjoz Service d'oncologie médicale

Besancon, France, 25030

CHU Morvan Institut de Cancérologie et d'Hématologie

Brest, France, 29200

Hopital Privé Jean Mermoz Service de Gastro entérologie et d'Oncologie médicale

Lyon, France, 69008

Hôpital Nord Franche-Comté - Site du Mittan Service d'oncologie médicale

Montbeliard, France, 25209

Centre Antoine Lacassagne Dpt d'Oncologie Médicale

Nice, France, 06189

Hôpital Saint-Antoine Service d'Oncologie Médicale

Paris, France, 75012

Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive

Paris, France, 75015

Hopital Haut-Leveque Hepato-gastroenterologie et oncologie digestive

Pessac, France, 33604

CHU Toulouse Rangueil Oncologie médicale digestive

Toulouse, France, 31059

Germany

Onkologische Schwerpunktpraxis Kurfuerstendamm

Berlin, Germany, 10707

Lübecker Onkologische Schwerpunktpraxis im Hochschulstadttei

Luebeck, Germany, 23562

Klinikum der Universität München Campus Großhadern, Medizinische Klinik und Poliklinik III

Muenchen, Germany, 81377

Hungary

Magyar Honvedseg Egeszsegugyi Kozpont Onkologiai Osztaly

Budapest, Hungary, 1062

Semmelweis University Radiology and Oncotherapy Clinic

Budapest, Hungary, 1083

Del-Pesti Centrumkh-Orsz. Hematologiai es Infektologiai Int. Szent Laszlo Telephely

Budapest, Hungary, 1097

Szent Imre Egyetem Oktatokorhaz Klinikai Onkologia

Budapest, Hungary, 1115

Orszagos Onkologiai Intezet "B" Belgyogyaszati-Onkologiai O. Es Klin. Farmakologiai O.

Budapest, Hungary, 1122

Uzsoki Utcai Korhaz Onkoradiologiai Osztaly

Budapest, Hungary, 1145

Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet

Debrecen, Hungary, 4032

Petz Aladar Megyei Oktato Korhaz Onkoradiologiai Osztaly

Győr, Hungary, 9024

Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont

Kecskemét, Hungary, 6000

Szabolcs-Szatmar-Bereg Megyei Korhazak Onkoradiologiai Osztaly

Nyíregyháza, Hungary, 4400

Pecsi Tudomanyegyetem, Klinikai Kozpont Onkoterapias Intezet

Pécs, Hungary, 7624

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kp. Onkoterápiás Klinika

Szeged, Hungary, 6720

JNSZ Megyei Hetenyi Geza Korhaz es Rendelointezet Megyei Onkologiai Centrum

Szolnok, Hungary, 5004

Markusovsky Egyetemi Oktatokorhaz Onkoradiologiai Osztaly

Szombathely, Hungary, 9700

Zala Megyei Korhaz Onkologiai osztaly

Zalaegerszeg, Hungary, 8900

Ireland

Bon Secours Hospital

Cork, Ireland, 90

Cork University Hospital Department of Medical Oncology

Cork, Ireland, T12 DC4A

The Adelaide and Meath Hospital

Dublin, Ireland, D24 NROA

Italy

Azienda Policlinico Universitaria - Presidio Monserrato Oncologia Medica

Cagliari, Italy, 09100

Azienda Socio Sanitaria Territoriale di Cremona ONCOLOGIA

Cremona, Italy, 26100

Istituto Nazionale Tumori I.R.C.C.S "Fondazione G. Pascale" Struttura Complessa di Oncologia Medica Addominale

Napoli, Italy, 80131

Istituto Oncologico Veneto IOV - IRCCS Unità Operativa Complessa Oncologia Medica 1

Padova, Italy, 35128

A.O.U. Pisana-Ospedale Santa Chiara U.O. di Oncologia Medica 2

Pisa, Italy, 56126

Ospedale San Carlo U.O. Oncologia Medica

Potenza, Italy, 85100

Arcispedale Santa Maria Nuova Unità di Oncologia

Reggio Emilia, Italy, 42123

Policlinico Universitario Campus Biomedico UOC di Oncologia Medica

Roma, Italy, 00128

Istituto Clinico Humanitas I.R.C.C.S Dipartimento di Oncologia Medica ed Ematologia

Rozzano (mi), Italy, 20089

IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia

San Giovanni Rotondo, Italy, 71013

Ospedale S. Bortolo -ULSS8 Berica Distretto Est U.O. ONCOLOGIA

Vicenza, Italy, 36100

Latvia

P. Stradins Clinical University Hospital

Riga, Latvia, 1002

Riga East Univerity Hospital Oncology Centre of Latvia

Riga, Latvia, 1079

Lithuania

Oncology Hospital, Branch of Hospital of Lithuanian Uni. of Health Sciences Kauno klinikos

Kaunas, Lithuania, 45434

Hospital of Lithuania Univ of Health Sciences Kauno klinikos Oncology Institute

Kaunas, Lithuania, LT-50161

Klaipeda University hospital

Klaipėda, Lithuania, 92288

National Cancer Institute

Vilnius, Lithuania, LT-08660

Netherlands

Rijnstate Oncologie

Arnhem, Netherlands, 6815 AD

Albert Schweitzer Ziekenhuis Interne Geneeskunde

Dordrecht, Netherlands, 3318 AT

Catharina Ziekenhuis Interne Gesneeskunde/Oncologie

Eindhoven, Netherlands, 5623 EJ

Ikazia Ziekenhuis Oncologie

Rotterdam, Netherlands, 3083 AN

ETZ Elisabeth Interne Geneeskunde

Tilburg, Netherlands, 5022 GC

Bernhoven Interne Geneeskunde

Uden, Netherlands, 5406 PT

Poland

Bialostockie Centrum Onkologii im Marii Curie-Sklodowskiej Oddzial Onkologii Klinicznej im Dr Ewy Pileckiej z pododdzialem Chemioterapii Dziennej

Białystok, Poland, 15-027

Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii

Gdańsk, Poland, 80-952

Przychodnia Lekarska "KOMED"

Konin, Poland, 62-500

SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii Oddzial Kliniczny Onkologii i Immunoonkologii

Olsztyn, Poland, 10-228

Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej

Opole, Poland, 45-061

Europejskie Centrum Zdrowia Otwock Oddzial Onkologii Klinicznej

Otwock, Poland, 05-400

Wielkopolskie Centrum Onkologii im Marii Sklodowskiej-Curie Oddzial Chemioterapii

Poznań, Poland, 61-866

NU-MED Centrum Diagnostyki i Terapii Onkologicznej Tomaszów Mazowiecki II Sp. z o.o., Pododdzial Chemioterapi

Tomaszów Mazowiecki, Poland, 97-200

M. Kopernika Provincial Hospital Oddzial Chemioterapii Nowotworow

Łódź, Poland, 93-513

Portugal

Hospital Garcia de Orta Serviço de Oncologia Médica

Almada, Portugal, 2805-267

HOSPITAL DE BRAGA Medical Oncology Department

Braga, Portugal, 4710-243

Centro Hospitalar e Universitário de Coimbra - CHUC Unidade de Inovação e Desenvolvimento (UID)

Coimbra, Portugal, 3000-075

Hospital CUF Infante Santo Oncology Department

Lisboa, Portugal, 1350-070

H. Da Luz Serviço de Oncologia

Lisboa, Portugal, 1500-650

Hospital Beatriz Ângelo Serviço de oncologia medic

Loures, Portugal, 2674-514

Centro Hospitalar do Porto - Hospital de Santo Antonio Institute of Biomedical Sciences Abel Salazar

Porto, Portugal, 4099-001

Instituto Português de Oncologia do Porto FG, EPE -IPO Porto Medical Oncology Dept.

Porto, Portugal, 4200-072

Romania

Institutul Oncologic "Prof Alexandru Trestioreanu" Busuresti Sectia Oncologie Medicala I

Bucuresti, Romania, 022328

Spitalul Clinic "Fundeni" Departament Oncologie Medicala - Gastroenterologie

Bucuresti, Romania, 022328

Spitalul Clinic "Coltea" Sectia Oncologie Medicala

Bucuresti, Romania, 030171

Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj Napoca Oncologie Medicala

Cluj-Napoca, Romania, 400015

Centrul de Oncologie Sf Nectarie Oncology Department

Craiova, Romania, 200347

S.C Oncolab S.R.L Sectia Oncologie Medicala

Craiova, Romania, 200385

Institutul Regional de Oncologie Iasi Clinica de Oncologie Medicala

Iaşi, Romania, 700483

Spitalul Clinic Judetean de Urgenta Sibiu Sectia Oncologie Medicala

Sibiu, Romania, 550245

S.C ONCOMED S.R.L Departament Oncologie Medicala

Timişoara, Romania, 300239

Russian Federation

Arkhangelsk Clinical Oncology Dispensary chemotherapy department

Arkhangel'sk, Russian Federation, 163045

Clinical Oncology Dispensary No.1 Chemotherapy Department

Krasnodar, Russian Federation, 350040

Kursk Regional Clinical Oncology Dispensary Oncology Department

Kursk, Russian Federation, 305524

Russian Cancer Research Center n.a. NN Blokhin Clinical Pharmacology and Chemotherapy

Moscow, Russian Federation, 115478

University Headache Clinic Outpatient oncology clinic

Moscow, Russian Federation, 121467

Moscow City Oncology Hospital # 62 chemotherapy department

Moscow, Russian Federation, 143423

Omsk Clinical Oncologic Dispensary Chemotherapy

Omsk, Russian Federation, 644046

Pyatigorsk Interdistrict Oncology Dispensary Chemotherapy department

Pyatigorsk, Russian Federation, 357502

Rostov Research Institute of Oncology Chemotherapy department

Rostov-on-Don, Russian Federation, 344037

Regional Clinical Oncology Dispensary

Ryazan', Russian Federation, 390011

Scientific Centre for Specialized Medical Care (oncological) Chemotherapy

Saint Petersburg, Russian Federation, 115478

National Medical Research Center of Oncology N.N. Petrova

Saint Petersburg, Russian Federation, 197758

Saint Petersburg City Oncology Clilnic

Saint Petersburg, Russian Federation, 198255

Multidisciplinary clinic "Reaviz"

Samara, Russian Federation, 443011

Oncology Dispensary No.2

Sochi, Russian Federation, 354057

State Research Institution of Oncology of Tomsk Chemotherapy

Tomsk, Russian Federation, 634024

SBIH of YR "Clinical oncology hospital" chemotherapy department

Yaroslavl, Russian Federation, 150054

Slovakia

Narodny onkologicky ustav Oddelenie klinickej onkologie

Bratislava, Slovakia, 833 10

Vychodoslovensky onkologicky ustav Oddelenie klinickej onkologie

Košice, Slovakia, 04191

Nemocnica s poliklinikou Stefana Kukuru, Michalovce, a.s Oddelenie okologie a radioterapie

Michalovce, Slovakia, 071 01

Ustredna vojenska nemocnica Ruzomberok Klinika radiacnej a klinickej onkologie

Ružomberok, Slovakia, 034 26

Spain

Hospital General Universitario Alicante Servicio de Oncología

Alicante, Spain, 03010

Hospital Germans Trias i Pujol Unidad de Investigación clínica (UIC) ICO-Oncología medica

Badalona, Spain, 08916

H. Valle de Hebrón Servicio de Oncología - (VHIR)

Barcelona, Spain, 08035

Hospital de la Santa Creu I Sant Pau Oncología Medica

Barcelona, Spain, 08041

Hospital Uni. Reina Sofía - Hospital Provincial Departamento de Oncología Médica

Córdoba, Spain, 14004

Hospital Virgen de las Nieves Unidad de Oncología Médica

Granada, Spain, 18014

Hospital Virgen de las Nieves Unidad de Oncología Médica

Granada, Spain, 1814

INSTITUTO CATALAN DE ONCOLOGÍA - ICO Oncología Médica

Hospitalet de Llobregat, Spain, 08908

Hospital Unviersitario Gregorio Marañon Servicio de Oncología Médica

Madrid, Spain, 28007

Hospital Universitario Ramón y Cajal, Servicio de Oncologia Médica

Madrid, Spain, 28034

H. Clínico San Carlos Servicio de Oncología Médica

Madrid, Spain, 28040

HOSPITAL 12 DE OCTUBRE Servicio Oncología Médica

Madrid, Spain, 28041

H. Universitario La Paz Oncología Médica

Madrid, Spain, 28046

Hospital Universitario Marqués de Valdecilla Oncología médica

Santander, Spain, 39008

H.Virgen Del Rocio

Sevilla, Spain, 41013

Hospital Quirónsalud Valencia Servicio de Oncología Médica

Valencia, Spain, 46010

Hospital Universitario Miguel Servet Servicio de Oncología

Zaragoza, Spain, 50009

Sweden

Falu Lasarett Onkologmottagningen

Falun, Sweden, 791 82

Lanssjukhuset Ryhov Onkologiska kliniken

Jönköping, Sweden, 551 85

Karolinska University Hospital, Solna Studiebehandlingsenheten, B8:09

Solna, Sweden, 171 64

Norrlands Universitetssjukhus Cancercentrum Umea

Umeå, Sweden, 901 85

Akademiska sjukhuset Onkologmottagningen

Uppsala, Sweden, 75185

Universitetssjukhuset Orebro

Örebro, Sweden, 701 85

Ukraine

Cherkasy Regional Oncological Dispensary Regional Clinical Oncological Centre

Cherkasy, Ukraine, 18009

Dnipro Regional Oncology Dispensary

Dnipro, Ukraine, 49055

MI "Dnipropetrovsk City Multi-field Clinical Hospital #4" Department of Oncology

Dnipro, Ukraine, 49102

Institute of Medical Radiology of S.P. Grygoryev of AMS UKR

Kharkiv, Ukraine, 61024

Kharkiv Regional Oncology Center

Kharkiv, Ukraine, 61070

National Institute of Cancer Abdominal Oncology Department

Kyiv, Ukraine, 03022

Kyiv City Clinical Oncology Centre Chemotherapy Department #2

Kyiv, Ukraine, 03115

Municipal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital", proctology department

Kyiv, Ukraine, 04107

Lviv Regional Oncology Center Chemotherapy department

Lviv, Ukraine, 79031

Odesa Regional Oncology Dispensary Day patient Department

Odesa, Ukraine, 65010

Podillia Regional Oncology Centre Chemotherapy Department

Vinnytsya, Ukraine, 21029

Regional Clinical Oncological Dispensary Department of Oncology

Zaporozhye, Ukraine, 69000

United Kingdom

Aberdeen Royal Infirmary Oncology Department

Aberdeen, United Kingdom, AB25 2ZN

University Hospitals Bristol Bristol Haematology & Oncology Centre

Bristol, United Kingdom, BS2 8ED

St James's University Hospital

Leeds, United Kingdom, LS9 7TF

Leicester Royal Infirmary The HOPE Clinical Trials Unit

Leicester, United Kingdom, LE1 5WW

Royal Marsden Hospital Department of Medicine

London, United Kingdom, SW3 6JJ

Hammersmith Hospital Gary Weston Centre

London, United Kingdom, W12 0HS

Sarah Cannon Research Institute UK Clinical Trials

London, United Kingdom, W1G 6AD

1st Floor East Wing Medical OncologyFulham Palace RoadHammersmith

London, United Kingdom, W6 8RF

Christie Hospital NHS Foundation Trust GI & Endocrine

Manchester, United Kingdom, M20 4BX

Glan Clwyd Hospital North Wales Cancer Treatment Centre

Rhyl, United Kingdom, LL18 5UJ

Royal Marsden Hospital Department of Medicine

Sutton, United Kingdom, SM2 5PT

Sponsors and Collaborators

Institut de Recherches Internationales Servier

ADIR, a Servier Group company

Investigators

• Principal Investigator: Thierry ANDRE, PhD; Medical Oncology departement Saint-Antoine hospital (Paris France 75012)

More Information

Additional Information:

Find Results on Servier Clinical Trial Data website 

Study Data/Documents: Individual Participant Data Set 

Study Protocol 

Statistical Analysis Plan 

Informed Consent Form 

Clinical Study Report 

study-level clinical trial data 

• Responsible Party: Institut de Recherches Internationales Servier
• ClinicalTrials.gov Identifier: NCT03869892
• Other Study ID Numbers: CL3-95005-006; 2017-004059-22 ( EudraCT Number ); U1111-1206-3198 ( Other Identifier: UTN )
• First Posted: March 11, 2019
• Last Update Posted: September 30, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

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.

• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
• 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.
• URL: https://clinicaltrials.servier.com/

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Servier ( Institut de Recherches Internationales Servier ):

Metastatic; Cancer; Colorectal; Colorectal Cancer; Colon; Rectum; Metastasis

Additional relevant MeSH terms:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Trifluridine; Bevacizumab; Capecitabine; Antineoplastic Agents, Immunological; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antiviral Agents; Anti-Infective Agents