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

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)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Colorectal Cancer
• Intervention / Treatment: Drug: Trifluridine/tipiracil hydrochloride (S95005); Biological: Bevacizumab experimental; Drug: Capecitabine; Biological: Bevacizumab control

• Study Type: Interventional
• Enrollment (Actual): 856
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Berazategui, Argentina, B1884BBF
    • Centro de Oncología e Investigación de Buenos Aires COIBA
  • Buenos Aires, Argentina, C1093AAS
    • Fundación Favaloro Oncology Unit
  • Ciudad Autonoma de Buenos aires, Argentina, C1426ANZ
    • Instituto Alexander Fleming
  • Ciudad Autonoma de Buenos aires, Argentina, C1431FWO
    • Hospital Universitario CEMIC Servicio de Oncología, Unidad de tumores gastrointestinales
  • Ciudad Autónoma de Buenos Aires, Argentina, 1264
    • Hospital de Gastroenterología Dr. Carlos Borino Udaondo Oncology Unit
  • La Rioja, Argentina, F5300COE
    • Centro Oncológico Riojano Integral CORI Fundación CORI para la Investigación y Prevención del Cáncer
  • Mendoza, Argentina, 5500
    • Fundación COIR Centro Oncológico de Interación Regional
  • Santa Fe, Argentina, S2000KZE
    • Instituto de Oncología de Rosario
  • Santa Fe, Argentina, S3000FFU
    • ISIS Centro especializado
  • Tucumán, Argentina, T4000IAK
    • Centro Medico San Roque
• Australia
  • Blacktown, Australia, 2148
    • Blacktown Hospital Cancer and Haematology Centre
  • Frankston, Australia, 3199
    • Frankston Private Peninsula and Southeast Oncology Group
  • Gateshead, Australia, 2290
    • Lake Macquarie Private Hospital
  • Kogarah, Australia, 2217
    • St George Hospital St George Hospital Cancer Care Centre
  • Wahroonga, Australia, 2076
    • Adventist HealthCare Integrated Cancer Centre
  • Wollongong, Australia, 2500
    • Southern Medical Day Care Centre
• Austria
  • Graz, Austria, 8036
    • Med. Universität Graz Klinische Abteilung für Onkologie
  • Innsbruck, Austria, 6020
    • Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin V
  • Linz, Austria, 4010
    • Ordensklinikum Linz Barmherzige Schwestern Interne I
  • Salzburg, Austria, 5020
    • Landeskrankenhaus (SALK) Universitätsklinik für Innere Medizin III (SALK)
  • St. Poelten, Austria, 3100
    • Universitätsklinikum St. Pölten Klinische Abteilung für Innere Medizin I
  • Wien, Austria, 1090
    • Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie
• Brazil
  • Barretos, Brazil, 14784-400
    • Hospital do Câncer de Barretos - Fundação Pio XII Unidade de Pesquisa Clínica
  • Belo Horizonte, Brazil, 30150-320
    • Cenantron - Clinica
  • Brasília, Brazil, 70200-730
    • Sirio Libanes DF - Centro de Oncologia de Braslia do Sirio- Centro Intergrado de Pesquisa
  • Ijuí, Brazil, 98700-000
    • Centro de Pesquisa Hospital de Caridade de Ijuí Unidade de Pesquisa Clínica
  • Porto Alegre, Brazil, 90880-480
    • Hospital Mae de Deus Oncologia
  • Salvador, Brazil, 41253-191
    • Hospital São Rafael Centro Intergrado de Pesquisa
  • Santo André, Brazil, 09060-870
    • CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncol Centro Intergrado de Pesquisa
  • São José Do Rio Preto, Brazil, 15090-000
    • Hospital de Base Centro Integrado de Pesquisa
  • São Paulo, Brazil, 01246-000
    • ICESP - Instituto do Câncer do Estado de São Paulo Centro Integrado de Pesquisa
  • São Paulo, Brazil, 01509-900
    • Hospital A C Camargo Unidade de Pesquisa Clinica
• Bulgaria
  • Burgas, Bulgaria, 8000
    • "Complex oncology center - Burgas" EOOD Department of medical oncology
  • Gabrovo, Bulgaria, 5300
    • "Multiprofile hosp. for active treatmen Dr. Tota Venkova" AD Department of medical oncology
  • Plovdiv, Bulgaria, 4004
    • "Complex oncology center - Plovdiv" EOOD, IInd base Dpt. of Med. oncology and onc. diseases in gastroenterology
  • Sofia, Bulgaria, 1330
    • "Medical Center Nadezhda Clinical" EOOD Medical Oncology Department
  • Sofia, Bulgaria, 1431
    • "UMHAT Sv. Ivan Rilski" EAD Clinic of clinical hematology, Dpt. of medical oncology
  • Sofia, Bulgaria, 1632
    • MHAT Serdika EOOD Department of Medical Oncology
  • Sofia, Bulgaria, 1756
    • Spec. hospital for active treatment of oncology dis. EOOD Department of medical oncology and palliative care
  • Varna, Bulgaria, 9003
    • SHAT of oncology diseases Dr. Marko Antonov Markov" EOOD Department of medical oncology and palliative therapy
  • Vratsa, Bulgaria, 3000
    • "Complex Ongology Center - Vratsa" EOOD Department of Medical oncology
• Czechia
  • Brno, Czechia, 656 53
    • Masarykuv onkologicky ustav Klinika komplexni onkologicke pece
  • Ostrava, Czechia
    • Fakultni nemocnice Ostrava Klinika onkologicka
  • Praha, Czechia, 128 08
    • Vseobecna fakultni nemocnice Onkologicka klinika VFN a 1. LF UK
  • Praha, Czechia, 140 59
    • Thomayerova nemocnice Onkologicka klinika 1. LF UK a TN
  • Praha, Czechia, 77900
    • Fakultni nemocnice Olomouc Onkologicka klinika
• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg Universitetshospital, Syd Onkologisk Afdelin
  • Herning, Denmark, 7400
    • Regionshospitalet Herning, Hospitalsenheden Vest Onkologisk Afdeling
  • Kobenhavn, Denmark, 2100
    • Rigshospitalet Onkologisk Klinik
  • Odense, Denmark, 5000
    • Odense Universitetshospital Onkologisk Afdeling R
• Estonia
  • Tallinn, Estonia, 11312
    • East Tallinn Central Hospital Center of Oncology
  • Tallinn, Estonia, 13419
    • North Estonia Medical Centre Foundation Oncology and Haematology clinic
  • Tartu, Estonia, 51014
    • Tartu University Hospital, Hematology - Oncology clinic, Radiotherapy and oncological therapy
• France
  • Avignon, France, 84918
    • Institut Sainte Catherine
  • Besancon, France, 25030
    • CHU Jean Minjoz Service d'oncologie médicale
  • Brest, France, 29200
    • CHU Morvan Institut de Cancérologie et d'Hématologie
  • Lyon, France, 69008
    • Hopital Privé Jean Mermoz Service de Gastro entérologie et d'Oncologie médicale
  • Montbeliard, France, 25209
    • Hôpital Nord Franche-Comté - Site du Mittan Service d'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
  • Pessac, France, 33604
    • Hopital Haut-Leveque Hepato-gastroenterologie et oncologie digestive
  • Toulouse, France, 31059
    • CHU Toulouse Rangueil Oncologie médicale digestive
• Germany
  • Berlin, Germany, 10707
    • Onkologische Schwerpunktpraxis Kurfuerstendamm
  • Luebeck, Germany, 23562
    • Lübecker Onkologische Schwerpunktpraxis im Hochschulstadttei
  • Muenchen, Germany, 81377
    • Klinikum der Universität München Campus Großhadern, Medizinische Klinik und Poliklinik III
• Hungary
  • Budapest, Hungary, 1062
    • Magyar Honvédség Egészségügyi Központ Onkológiai Osztály
  • Budapest, Hungary, 1083
    • Semmelweis University Radiology and Oncotherapy Clinic
  • Budapest, Hungary, 1097
    • Del-Pesti Centrumkh-Orsz. Hematologiai es Infektologiai Int. Szent Laszlo Telephely
  • Budapest, Hungary, 1115
    • Szent Imre Egyetem Oktatokorhaz Klinikai Onkologia
  • Budapest, Hungary, 1122
    • Orszagos Onkologiai Intezet "B" Belgyogyaszati-Onkologiai O. Es Klin. Farmakologiai O.
  • Budapest, Hungary, 1145
    • Uzsoki Utcai Korhaz Onkoradiologiai Osztaly
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet
  • Gyula, Hungary, 57000
    • Békés Megyei Központi Kórház
  • Győr, Hungary, 9024
    • Petz Aladar Megyei Oktato Korhaz Onkoradiologiai Osztaly
  • Kecskemét, Hungary, 6000
    • Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont
  • Nyíregyháza, Hungary, 4400
    • Szabolcs-Szatmar-Bereg Megyei Korhazak Onkoradiologiai Osztaly
  • Pécs, Hungary, 7624
    • Pecsi Tudomanyegyetem, Klinikai Kozpont Onkoterapias Intezet
  • Szeged, Hungary, 6720
    • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kp. Onkoterápiás Klinika
  • Szolnok, Hungary, 5004
    • JNSZ Megyei Hetenyi Geza Korhaz es Rendelointezet Megyei Onkologiai Centrum
  • Szombathely, Hungary, 9700
    • Markusovsky Egyetemi Oktatokorhaz Onkoradiologiai Osztaly
  • Zalaegerszeg, Hungary, 8900
    • Zala Megyei Korhaz Onkologiai osztaly
• Ireland
  • Cork, Ireland, 90
    • Bon Secours Hospital
  • Cork, Ireland, T12 DC4A
    • Cork University Hospital Department of Medical Oncology
  • Dublin, Ireland, D24 NROA
    • The Adelaide and Meath Hospital
• Italy
  • Cagliari, Italy, 09100
    • Azienda Policlinico Universitaria - Presidio Monserrato Oncologia Medica
  • Cremona, Italy, 26100
    • Azienda Socio Sanitaria Territoriale di Cremona ONCOLOGIA
  • Napoli, Italy, 80131
    • Istituto Nazionale Tumori I.R.C.C.S "Fondazione G. Pascale" Struttura Complessa di Oncologia Medica Addominale
  • Padova, Italy, 35128
    • Istituto Oncologico Veneto IOV - IRCCS Unità Operativa Complessa Oncologia Medica 1
  • Pisa, Italy, 56126
    • A.O.U. Pisana-Ospedale Santa Chiara U.O. di Oncologia Medica 2
  • Potenza, Italy, 85100
    • Ospedale San Carlo U.O. Oncologia Medica
  • Reggio Emilia, Italy, 42123
    • Arcispedale Santa Maria Nuova Unità di Oncologia
  • Roma, Italy, 00128
    • Policlinico Universitario Campus Biomedico UOC 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
  • Vicenza, Italy, 36100
    • Ospedale S. Bortolo -ULSS8 Berica Distretto Est U.O. ONCOLOGIA
• Latvia
  • Riga, Latvia, 1002
    • P. Stradins Clinical University Hospital
  • Riga, Latvia, 1079
    • Riga East Univerity Hospital Oncology Centre of Latvia
• Lithuania
  • Kaunas, Lithuania, 45434
    • Oncology Hospital, Branch of Hospital of Lithuanian Uni. of Health Sciences Kauno klinikos
  • Kaunas, Lithuania, LT-50161
    • Hospital of Lithuania Univ of Health Sciences Kauno klinikos Oncology Institute
  • Klaipėda, Lithuania, 92288
    • Klaipeda University Hospital
  • Vilnius, Lithuania, LT-08660
    • National Cancer Institute
• Netherlands
  • Arnhem, Netherlands, 6815 AD
    • Rijnstate Oncologie
  • Dordrecht, Netherlands, 3318 AT
    • Albert Schweitzer Ziekenhuis Interne Geneeskunde
  • Eindhoven, Netherlands, 5623 EJ
    • Catharina Ziekenhuis Interne Gesneeskunde/Oncologie
  • Rotterdam, Netherlands, 3083 AN
    • Ikazia Ziekenhuis Oncologie
  • Tilburg, Netherlands, 5022 GC
    • ETZ Elisabeth Interne Geneeskunde
  • Uden, Netherlands, 5406 PT
    • Bernhoven Interne Geneeskunde
• Poland
  • Białystok, Poland, 15-027
    • Bialostockie Centrum Onkologii im Marii Curie-Sklodowskiej Oddzial Onkologii Klinicznej im Dr Ewy Pileckiej z pododdzialem Chemioterapii Dziennej
  • Gdańsk, Poland, 80-952
    • Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii
  • Konin, Poland, 62-500
    • Przychodnia Lekarska "KOMED"
  • Olsztyn, Poland, 10-228
    • SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii Oddzial Kliniczny Onkologii i Immunoonkologii
  • Opole, Poland, 45-061
    • Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej
  • Poznań, Poland, 61-866
    • Wielkopolskie Centrum Onkologii im Marii Sklodowskiej-Curie Oddzial Chemioterapii
  • Tomaszów Mazowiecki, Poland, 97-200
    • NU-MED Centrum Diagnostyki i Terapii Onkologicznej Tomaszów Mazowiecki II Sp. z o.o., Pododdzial Chemioterapi
  • Łódź, Poland, 93-513
    • M. Kopernika Provincial Hospital Oddzial Chemioterapii Nowotworow
• Portugal
  • Almada, Portugal, 2805-267
    • Hospital Garcia de Orta Serviço de Oncologia Médica
  • Coimbra, Portugal, 3000-075
    • Centro Hospitalar e Universitário de Coimbra - CHUC Unidade de Inovação e Desenvolvimento (UID)
  • Lisboa, Portugal, 1649-035
    • Centro Hospitalar Lisboa Norte, Hospital de Santa Maria Serviço de Oncologia Médica
  • Loures, Portugal, 2674-514
    • Hospital Beatriz Ângelo Serviço de oncologia medic
  • Porto, Portugal, 4200-072
    • Instituto Português de Oncologia do Porto FG, EPE -IPO Porto Medical Oncology Dept.
• Romania
  • Bucuresti, Romania, 022328
    • Institutul Oncologic "Prof Alexandru Trestioreanu" Busuresti Sectia Oncologie Medicala I
  • Bucuresti, Romania, 030171
    • Spitalul Clinic "Coltea" Sectia Oncologie Medicala
  • Cluj-Napoca, Romania, 400015
    • Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj Napoca Oncologie Medicala
  • Craiova, Romania, 200347
    • Centrul de Oncologie Sf Nectarie Oncology Department
  • Craiova, Romania, 200385
    • S.C Oncolab S.R.L Sectia Oncologie Medicala
  • Iaşi, Romania, 700483
    • Institutul Regional de Oncologie Iasi Clinica de Oncologie Medicala
  • Sibiu, Romania, 550245
    • Spitalul Clinic Judetean de Urgenta Sibiu Sectia Oncologie Medicala
  • Timişoara, Romania, 300239
    • S.C ONCOMED S.R.L Departament Oncologie Medicala
• Russian Federation
  • Arkhangel'sk, Russian Federation, 163045
    • Arkhangelsk Clinical Oncology Dispensary chemotherapy department
  • Krasnodar, Russian Federation, 350040
    • Clinical Oncology Dispensary No.1 Chemotherapy Department
  • Kursk, Russian Federation, 305524
    • Kursk Regional Clinical Oncology Dispensary Oncology Department
  • Moscow, Russian Federation, 115478
    • Russian Cancer Research Center n.a. NN Blokhin Clinical Pharmacology and Chemotherapy
  • Moscow, Russian Federation, 121467
    • University Headache Clinic Outpatient oncology clinic
  • Moscow, Russian Federation, 143423
    • Moscow City Oncology Hospital # 62 chemotherapy department
  • Omsk, Russian Federation, 644046
    • Omsk Clinical Oncologic Dispensary Chemotherapy
  • Pyatigorsk, Russian Federation, 357502
    • Pyatigorsk Interdistrict Oncology Dispensary Chemotherapy department
  • Rostov-on-Don, Russian Federation, 344037
    • Rostov Research Institute of Oncology Chemotherapy department
  • Ryazan', Russian Federation, 390011
    • Regional Clinical Oncology Dispensary
  • Saint Petersburg, Russian Federation, 115478
    • Scientific Centre for Specialized Medical Care (oncological) Chemotherapy
  • Saint Petersburg, Russian Federation, 197758
    • National Medical Research Center of Oncology N.N. Petrova
  • Saint Petersburg, Russian Federation, 198255
    • Saint Petersburg City Oncology Clilnic
  • Samara, Russian Federation, 443011
    • Multidisciplinary clinic "Reaviz"
  • Sochi, Russian Federation, 354057
    • Oncology Dispensary No.2
  • Tomsk, Russian Federation, 634024
    • State Research Institution of Oncology of Tomsk Chemotherapy
  • Yaroslavl, Russian Federation, 150054
    • SBIH of YR "Clinical oncology hospital" chemotherapy department
• Slovakia
  • Bratislava, Slovakia, 833 10
    • Narodny onkologicky ustav Oddelenie klinickej onkologie
  • Košice, Slovakia, 04191
    • Vychodoslovensky onkologicky ustav Oddelenie klinickej onkologie
• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario Alicante Servicio de Oncología
  • Badalona, Spain, 08916
    • Hospital Germans Trias i Pujol Unidad de Investigación clínica (UIC) ICO-Oncología medica
  • Barcelona, Spain, 08035
    • H. Valle de Hebrón Servicio de Oncología - (VHIR)
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu I Sant Pau Oncología Medica
  • Córdoba, Spain, 14004
    • Hospital Uni. Reina Sofía - Hospital Provincial Departamento de Oncología Médica
  • Hospitalet de Llobregat, Spain, 08908
    • INSTITUTO CATALAN DE ONCOLOGÍA - ICO Oncología Médica
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal, Servicio de Oncologia Médica
  • Madrid, Spain, 28007
    • Hospital Unviersitario Gregorio Marañon Servicio de Oncología Médica
  • Madrid, Spain, 28040
    • H. Clínico San Carlos Servicio de Oncología Médica
  • Madrid, Spain, 28041
    • HOSPITAL 12 DE OCTUBRE Servicio Oncología Médica
  • Madrid, Spain, 28046
    • H. Universitario La Paz Oncología Médica
  • Santander, Spain, 39008
    • Hospital Universitario Marqués de Valdecilla Oncología médica
  • Sevilla, Spain, 41013
    • H.Virgen Del Rocio
  • Valencia, Spain, 46010
    • Hospital Quirónsalud Valencia Servicio de Oncología Médica
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet Servicio de Oncología
• Sweden
  • Falun, Sweden, 791 82
    • Falu Lasarett Onkologmottagningen
  • Jönköping, Sweden, 551 85
    • Lanssjukhuset Ryhov Onkologiska kliniken
  • Solna, Sweden, 171 64
    • Karolinska University Hospital, Solna Studiebehandlingsenheten, B8:09
  • Umeå, Sweden, 901 85
    • Norrlands Universitetssjukhus Cancercentrum Umea
  • Örebro, Sweden, 701 85
    • Universitetssjukhuset Örebro
• Ukraine
  • Cherkasy, Ukraine, 18009
    • Cherkasy Regional Oncological Dispensary Regional Clinical Oncological Centre
  • Dnipro, Ukraine, 49055
    • Dnipro Regional Oncology Dispensary
  • Dnipro, Ukraine, 49102
    • MI "Dnipropetrovsk City Multi-field Clinical Hospital #4" Department of Oncology
  • Kharkiv, Ukraine, 61024
    • Institute of Medical Radiology of S.P. Grygoryev of AMS UKR
  • Kyiv, Ukraine, 03022
    • National Institute of Cancer Abdominal Oncology Department
  • Kyiv, Ukraine, 03115
    • Kyiv City Clinical Oncology Centre Chemotherapy Department #2
  • Kyiv, Ukraine, 04107
    • Municipal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital", proctology department
  • Lviv, Ukraine, 79031
    • Lviv Regional Oncology Center Chemotherapy department
  • Odesa, Ukraine, 65010
    • Odesa Regional Oncology Dispensary Day patient Department
  • Vinnytsya, Ukraine, 21029
    • Podillia Regional Oncology Centre Chemotherapy Department
  • Zaporozhye, Ukraine, 69000
    • Regional Clinical Oncological Dispensary Department of Oncology
• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZN
    • Aberdeen Royal Infirmary Oncology Department
  • Bristol, United Kingdom, BS2 8ED
    • University Hospitals Bristol Bristol Haematology & Oncology Centre
  • Leeds, United Kingdom, LS9 7TF
    • St James's University Hospital
  • Leicester, United Kingdom, LE1 5WW
    • Leicester Royal Infirmary The HOPE Clinical Trials Unit
  • London, United Kingdom, SW3 6JJ
    • Royal Marsden Hospital Department of Medicine
  • London, United Kingdom, W12 0HS
    • Hammersmith Hospital Gary Weston Centre
  • London, United Kingdom, W1G 6AD
    • Sarah Cannon Research Institute UK Clinical Trials
  • London, United Kingdom, W6 8RF
    • Imperial Healthcare NHS Trust Charing Cross Hospital
  • Manchester, United Kingdom, M20 4BX
    • Christie Hospital NHS Foundation Trust GI & Endocrine
  • Rhyl, United Kingdom, LL18 5UJ
    • Glan Clwyd Hospital North Wales Cancer Treatment Centre
  • Sutton, United Kingdom, SM2 5PT
    • Royal Marsden Hospital Department of Medicine

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Time elapsed between the date of randomization and the date of death due to any cause.	Up to 24 months
Overall response rate (ORR)	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.	Up to 24 months
Disease control rate (DCR)	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.	Up to 24 months
Duration of response (DoR)	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.	Up to 24 months
Time to treatment failure (TTF)	The time from randomization to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death.	Up to 24 months

Collaborators and Investigators

• Sponsor: Institut de Recherches Internationales Servier
• Collaborators: ADIR, a Servier Group company
• Investigators: Principal Investigator: Thierry ANDRE, PhD, Medical Oncology departement Saint-Antoine hospital (Paris France 75012)

Publications and helpful links

General Publications

• Estevez-Fraga C, Tabrizi SJ, Wild EJ. Huntington's Disease Clinical Trials Corner: November 2022. J Huntingtons Dis. 2022;11(4):351-367. doi: 10.3233/JHD-229006.

Helpful Links

• First Lay Summary
• First Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2019
• Primary Completion (Actual): June 29, 2021
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: February 23, 2018
• First Submitted That Met QC Criteria: March 8, 2019
• First Posted (Actual): March 11, 2019

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Cancer; Metastatic; Colorectal Cancer; Colon; Colorectal; Metastasis; Rectum
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Capecitabine; Bevacizumab; Trifluridine
• Other Study ID Numbers: CL3-95005-006; 2017-004059-22 (EudraCT Number); U1111-1206-3198 (Other Identifier: UTN)

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 drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No