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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03869892
Recruitment Status : Active, not recruiting
First Posted : March 11, 2019
Last Update Posted : April 15, 2022
ADIR, a Servier Group company
Information provided by (Responsible Party):
Servier ( Institut de Recherches Internationales Servier )

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

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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

Resource links provided by the National Library of Medicine

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.

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03869892

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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
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
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
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
"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
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
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
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
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
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
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
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
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
P. Stradins Clinical University Hospital
Riga, Latvia, 1002
Riga East Univerity Hospital Oncology Centre of Latvia
Riga, Latvia, 1079
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
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
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
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
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
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
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
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
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
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
Layout table for investigator information
Principal Investigator: Thierry ANDRE, PhD Medical Oncology departement Saint-Antoine hospital (Paris France 75012)
Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the site

Layout table for additonal information
Responsible Party: Institut de Recherches Internationales Servier 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    Key Record Dates
Last Update Posted: April 15, 2022
Last Verified: April 2022
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.

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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 ):
Colorectal Cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents