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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03869892
Recruitment Status : Recruiting
First Posted : March 11, 2019
Last Update Posted : January 23, 2020
Sponsor:
Collaborator:
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)
Estimated Enrollment : 854 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
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

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 ClinicalTrials.gov identifier (NCT number): NCT03869892


Contacts
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Contact: Institut de Recherches Internationales Servier Clinical Studies Department +33 1 55 72 43 66 clinical.trial.management@servier.com

Locations
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Argentina
Centro de Oncología e Investigación de Buenos Aires COIBA Recruiting
Berazategui, Argentina, B1884BBF
Fundación Favaloro Oncology Unit Recruiting
Buenos Aires, Argentina, C1093AAS
Centro Oncológico Riojano Integral CORI Fundación CORI para la Investigación y Prevención del Cáncer Recruiting
La Rioja, Argentina, F5300COE
Fundación COIR Centro Oncológico de Interación Regional Recruiting
Mendoza, Argentina, 5500
Instituto de Oncología de Rosario Recruiting
Santa Fe, Argentina, S2000KZE
ISIS Centro especializado Recruiting
Santa Fe, Argentina, S3000FFU
Centro Médico San Roque Recruiting
Tucumán, Argentina, T4000IAK
Australia
Blacktown Hospital Cancer and Haematology Centre Recruiting
Blacktown, Australia, 2148
Frankston Private Peninsula and Southeast Oncology Group Recruiting
Frankston, Australia, 3199
Lake Macquarie Private Hospital Recruiting
Gateshead, Australia, 2290
St George Hospital St George Hospital Cancer Care Centre Recruiting
Kogarah, Australia, 2217
Adventist HealthCare Integrated Cancer Centre Recruiting
Wahroonga, Australia, 2076
Southern Medical Day Care Centre Recruiting
Wollongong, Australia, 2500
Austria
Med. Universität Graz Klinische Abteilung für Onkologie Recruiting
Graz, Austria, 8036
Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin V Recruiting
Innsbruck, Austria, 6020
Ordensklinikum Linz Barmherzige Schwestern Interne I Recruiting
Linz, Austria, 4010
Landeskrankenhaus (SALK) Universitätsklinik für Innere Medizin III (SALK) Recruiting
Salzburg, Austria, 5020
Universitätsklinikum St. Pölten Klinische Abteilung für Innere Medizin I Recruiting
St. Poelten, Austria, 3100
Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie Recruiting
Wien, Austria, 1090
Brazil
Hospital do Câncer de Barretos - Fundação Pio XII Unidade de Pesquisa Clínica Recruiting
Barretos, Brazil, 14784-400
Cenantron - Clinica Recruiting
Belo Horizonte, Brazil, 30150-320
Sirio Libanes DF - Centro de Oncologia de Braslia do Sirio- Centro Intergrado de Pesquisa Recruiting
Brasília, Brazil, 70200-730
Centro de Pesquisa Hospital de Caridade de Ijuí Unidade de Pesquisa Clínica Recruiting
Ijuí, Brazil, 98700-000
Hospital Mae de Deus Oncologia Recruiting
Porto Alegre, Brazil, 90880-480
Hospital São Rafael Centro Intergrado de Pesquisa Recruiting
Salvador, Brazil, 41253-191
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncol Centro Intergrado de Pesquisa Recruiting
Santo André, Brazil, 09060-870
Hospital de Base Centro Integrado de Pesquisa Recruiting
São José Do Rio Preto, Brazil, 15090-000
ICESP - Instituto do Câncer do Estado de São Paulo Centro Integrado de Pesquisa Recruiting
São Paulo, Brazil, 01246-000
Hospital A C Camargo Unidade de Pesquisa Clinica Recruiting
São Paulo, Brazil, 01509-900
Bulgaria
"Complex oncology center - Burgas" EOOD Department of medical oncology Recruiting
Burgas, Bulgaria, 8000
"Multiprofile hosp. for active treatmen Dr. Tota Venkova" AD Department of medical oncology Recruiting
Gabrovo, Bulgaria, 5300
SHAT of oncology diseases Dr. Marko Antonov Markov" EOOD Department of medical oncology and palliative therapy Recruiting
Varna, Bulgaria, 9003
Czechia
Masarykuv onkologicky ustav Klinika komplexni onkologicke pece Recruiting
Brno, Czechia, 656 53
Vseobecna fakultni nemocnice Onkologicka klinika VFN a 1. LF UK Recruiting
Praha, Czechia, 128 08
Thomayerova nemocnice Onkologicka klinika 1. LF UK a TN Recruiting
Praha, Czechia, 140 59
Denmark
Aalborg Universitetshospital, Syd Onkologisk Afdelin Recruiting
Aalborg, Denmark, 9000
Regionshospitalet Herning, Hospitalsenheden Vest Onkologisk Afdeling Recruiting
Herning, Denmark, 7400
Rigshospitalet Onkologisk Klinik Recruiting
Kobenhavn, Denmark, 2100
Odense Universitetshospital Onkologisk Afdeling R Recruiting
Odense, Denmark, 5000
Estonia
East Tallinn Central Hospital Center of Oncology Recruiting
Tallinn, Estonia, 11312
North Estonia Medical Centre Foundation Oncology and Haematology clinic Recruiting
Tallinn, Estonia, 13419
Tartu University Hospital, Hematology - Oncology clinic, Radiotherapy and oncological therapy Recruiting
Tartu, Estonia, 51014
France
Institut Sainte Catherine Recruiting
Avignon, France, 84918
CHU Jean Minjoz Service d'oncologie médicale Recruiting
Besancon, France, 25030
CHU Morvan Institut de Cancérologie et d'Hématologie Recruiting
Brest, France, 29200
Hopital Privé Jean Mermoz Service de Gastro entérologie et d'Oncologie médicale Recruiting
Lyon, France, 69008
Hôpital Nord Franche-Comté - Site du Mittan Service d'oncologie médicale Recruiting
Montbeliard, France, 25209
Centre Antoine Lacassagne Dpt d'Oncologie Médicale Recruiting
Nice, France, 06189
Hôpital Saint-Antoine Service d'Oncologie Médicale Recruiting
Paris, France, 75012
Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive Recruiting
Paris, France, 75015
Hopital Haut-Leveque Hepato-gastroenterologie et oncologie digestive Recruiting
Pessac, France, 33604
CHU Toulouse Rangueil Oncologie médicale digestive Recruiting
Toulouse, France, 31059
Germany
Onkologische Schwerpunktpraxis Kurfuerstendamm Recruiting
Berlin, Germany, 10707
Lübecker Onkologische Schwerpunktpraxis im Hochschulstadttei Recruiting
Luebeck, Germany, 23562
Klinikum der Universität München Campus Großhadern, Medizinische Klinik und Poliklinik III Recruiting
Muenchen, Germany, 81377
Hungary
Magyar Honvedseg Egeszsegugyi Kozpont Onkologiai Osztaly Not yet recruiting
Budapest, Hungary, 1062
Semmelweis University Radiology and Oncotherapy Clinic Recruiting
Budapest, Hungary, 1083
Del-Pesti Centrumkh-Orsz. Hematologiai es Infektologiai Int. Szent Laszlo Telephely Recruiting
Budapest, Hungary, 1097
Szent Imre Egyetem Oktatokorhaz Klinikai Onkologia Recruiting
Budapest, Hungary, 1115
Orszagos Onkologiai Intezet "B" Belgyogyaszati-Onkologiai O. Es Klin. Farmakologiai O. Recruiting
Budapest, Hungary, 1122
Uzsoki Utcai Korhaz Onkoradiologiai Osztaly Recruiting
Budapest, Hungary, 1145
Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet Recruiting
Debrecen, Hungary, 4032
Petz Aladar Megyei Oktato Korhaz Onkoradiologiai Osztaly Recruiting
Győr, Hungary, 9024
Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont Recruiting
Kecskemét, Hungary, 6000
Szabolcs-Szatmar-Bereg Megyei Korhazak Onkoradiologiai Osztaly Recruiting
Nyíregyháza, Hungary, 4400
Pecsi Tudomanyegyetem, Klinikai Kozpont Onkoterapias Intezet Recruiting
Pécs, Hungary, 7624
JNSZ Megyei Hetenyi Geza Korhaz es Rendelointezet Megyei Onkologiai Centrum Recruiting
Szolnok, Hungary, 5004
Markusovsky Egyetemi Oktatokorhaz Onkoradiologiai Osztaly Recruiting
Szombathely, Hungary, 9700
Zala Megyei Korhaz Onkologiai osztaly Not yet recruiting
Zalaegerszeg, Hungary, 8900
Ireland
Bon Secours Hospital Recruiting
Cork, Ireland, 90
Cork University Hospital Department of Medical Oncology Recruiting
Cork, Ireland, T12 DC4A
Italy
Azienda Policlinico Universitaria - Presidio Monserrato Oncologia Medica Recruiting
Cagliari, Italy, 09100
Azienda Socio Sanitaria Territoriale di Cremona ONCOLOGIA Recruiting
Cremona, Italy, 26100
Istituto Nazionale Tumori I.R.C.C.S "Fondazione G. Pascale" Struttura Complessa di Oncologia Medica Addominale Recruiting
Napoli, Italy, 80131
Istituto Oncologico Veneto IOV - IRCCS Unità Operativa Complessa Oncologia Medica 1 Recruiting
Padova, Italy, 35128
A.O.U. Pisana-Ospedale Santa Chiara U.O. di Oncologia Medica 2 Recruiting
Pisa, Italy, 56126
Ospedale San Carlo U.O. Oncologia Medica Recruiting
Potenza, Italy, 85100
Arcispedale Santa Maria Nuova Unità di Oncologia Recruiting
Reggio Emilia, Italy, 42123
Policlinico Universitario Campus Biomedico UOC di Oncologia Medica Recruiting
Roma, Italy, 00128
Istituto Clinico Humanitas I.R.C.C.S Dipartimento di Oncologia Medica ed Ematologia Recruiting
Rozzano (mi), Italy, 20089
IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia Recruiting
San Giovanni Rotondo, Italy, 71013
Ospedale S. Bortolo -ULSS8 Berica Distretto Est U.O. ONCOLOGIA Recruiting
Vicenza, Italy, 36100
Latvia
P. Stradins Clinical University Hospital Recruiting
Riga, Latvia, 1002
Riga East Univerity Hospital Oncology Centre of Latvia Recruiting
Riga, Latvia, 1079
Lithuania
Oncology Hospital, Branch of Hospital of Lithuanian Uni. of Health Sciences Kauno klinikos Recruiting
Kaunas, Lithuania, 45434
Hospital of Lithuania Univ of Health Sciences Kauno klinikos Oncology Institute Recruiting
Kaunas, Lithuania, LT-50161
Klaipeda University hospital Recruiting
Klaipėda, Lithuania, 92288
National Cancer Institute Recruiting
Vilnius, Lithuania, LT-08660
Netherlands
Rijnstate Oncologie Recruiting
Arnhem, Netherlands, 6815 AD
Albert Schweitzer Ziekenhuis Interne Geneeskunde Recruiting
Dordrecht, Netherlands, 3318 AT
Catharina Ziekenhuis Interne Gesneeskunde/Oncologie Recruiting
Eindhoven, Netherlands, 5623 EJ
St. Anna Ziekenhuis Interne Geneeskunde Recruiting
Geldrop, Netherlands, 5664 EH
Ikazia Ziekenhuis Oncologie Recruiting
Rotterdam, Netherlands, 3083 AN
ETZ Elisabeth Interne Geneeskunde Recruiting
Tilburg, Netherlands, 5022 GC
Bernhoven Interne Geneeskunde Recruiting
Uden, Netherlands, 5406 PT
Poland
Bialostockie Centrum Onkologii im Marii Curie-Sklodowskiej Oddzial Onkologii Klinicznej im Dr Ewy Pileckiej z pododdzialem Chemioterapii Dziennej Recruiting
Białystok, Poland, 15-027
Przychodnia Lekarska "KOMED" Recruiting
Konin, Poland, 62-500
SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii Oddzial Kliniczny Onkologii i Immunoonkologii Recruiting
Olsztyn, Poland, 10-228
Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej Recruiting
Opole, Poland, 45-061
NU-MED Centrum Diagnostyki i Terapii Onkologicznej Tomaszów Mazowiecki II Sp. z o.o., Pododdzial Chemioterapi Recruiting
Tomaszów Mazowiecki, Poland, 97-200
Portugal
Centro Hospitalar do Porto - Hospital de Santo Antonio Institute of Biomedical Sciences Abel Salazar Recruiting
Porto, Portugal, 4099-001
Instituto Português de Oncologia do Porto FG, EPE -IPO Porto Medical Oncology Dept. Recruiting
Porto, Portugal, 4200-072
Romania
Institutul Oncologic "Prof Alexandru Trestioreanu" Busuresti Sectia Oncologie Medicala I Recruiting
Bucuresti, Romania, 022328
Spitalul Clinic "Fundeni" Departament Oncologie Medicala - Gastroenterologie Recruiting
Bucuresti, Romania, 022328
Spitalul Clinic "Coltea" Sectia Oncologie Medicala Not yet recruiting
Bucuresti, Romania, 030171
Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj Napoca Oncologie Medicala Recruiting
Cluj-Napoca, Romania, 400015
S.C Oncolab S.R.L Sectia Oncologie Medicala Recruiting
Craiova, Romania, 200385
Institutul Regional de Oncologie Iasi Clinica de Oncologie Medicala Recruiting
Iaşi, Romania, 700483
Spitalul Clinic Judetean de Urgenta Sibiu Sectia Oncologie Medicala Recruiting
Sibiu, Romania, 550245
S.C ONCOMED S.R.L Departament Oncologie Medicala Recruiting
Timişoara, Romania, 300239
Russian Federation
Arkhangelsk Clinical Oncology Dispensary chemotherapy department Recruiting
Arkhangel'sk, Russian Federation, 163045
Clinical Oncology Dispensary No.1 Chemotherapy Department Recruiting
Krasnodar, Russian Federation, 350040
Kursk Regional Clinical Oncology Dispensary Oncology Department Recruiting
Kursk, Russian Federation, 305524
Russian Cancer Research Center n.a. NN Blokhin Clinical Pharmacology and Chemotherapy Recruiting
Moscow, Russian Federation, 115478
Moscow City Oncology Hospital # 62 chemotherapy department Recruiting
Moscow, Russian Federation, 143423
Omsk Clinical Oncologic Dispensary Chemotherapy Recruiting
Omsk, Russian Federation, 644046
Pyatigorsk Interdistrict Oncology Dispensary Chemotherapy department Recruiting
Pyatigorsk, Russian Federation, 357502
Rostov Research Institute of Oncology Chemotherapy department Recruiting
Rostov-on-Don, Russian Federation, 344037
Regional Clinical Oncology Dispensary Recruiting
Ryazan', Russian Federation, 390011
Scientific Centre for Specialized Medical Care (oncological) Chemotherapy Recruiting
Saint Petersburg, Russian Federation, 115478
Saint Petersburg City Oncology Clilnic Recruiting
Saint Petersburg, Russian Federation, 198255
Multidisciplinary clinic "Reaviz" Recruiting
Samara, Russian Federation, 443011
Oncology Dispensary No.2 Recruiting
Sochi, Russian Federation, 354057
State Research Institution of Oncology of Tomsk Chemotherapy Recruiting
Tomsk, Russian Federation, 634024
SBIH of YR "Clinical oncology hospital" chemotherapy department Recruiting
Yaroslavl, Russian Federation, 150054
Slovakia
Narodny onkologicky ustav Oddelenie klinickej onkologie Recruiting
Bratislava, Slovakia, 833 10
Spain
Hospital General Universitario Alicante Servicio de Oncología Recruiting
Alicante, Spain, 03010
Hospital Germans Trias i Pujol Unidad de Investigación clínica (UIC) ICO-Oncología medica Recruiting
Badalona, Spain, 08916
H. Valle de Hebrón Servicio de Oncología - (VHIR) Recruiting
Barcelona, Spain, 08035
Hospital de la Santa Creu I Sant Pau Oncología Medica Recruiting
Barcelona, Spain, 08041
Hospital Uni. Reina Sofía - Hospital Provincial Departamento de Oncología Médica Recruiting
Córdoba, Spain, 14004
Hospital Virgen de las Nieves Unidad de Oncología Médica Recruiting
Granada, Spain, 18014
INSTITUTO CATALAN DE ONCOLOGÍA - ICO Oncología Médica Recruiting
Hospitalet de Llobregat, Spain, 08908
Hospital Unviersitario Gregorio Marañon Servicio de Oncología Médica Recruiting
Madrid, Spain, 28007
Hospital Universitario Ramón y Cajal, Servicio de Oncologia Médica Recruiting
Madrid, Spain, 28034
H. Clínico San Carlos Servicio de Oncología Médica Recruiting
Madrid, Spain, 28040
HOSPITAL 12 DE OCTUBRE Servicio Oncología Médica Recruiting
Madrid, Spain, 28041
H. Universitario La Paz Oncología Médica Recruiting
Madrid, Spain, 28046
Hospital Universitario Marqués de Valdecilla Oncología médica Recruiting
Santander, Spain, 39008
H.Virgen Del Rocio Recruiting
Sevilla, Spain, 41013
Hospital Quirónsalud Valencia Servicio de Oncología Médica Recruiting
Valencia, Spain, 46010
Hospital Universitario Miguel Servet Servicio de Oncología Recruiting
Zaragoza, Spain, 50009
Sweden
Falu Lasarett Onkologmottagningen Recruiting
Falun, Sweden, 791 82
Lanssjukhuset Ryhov Onkologiska kliniken Recruiting
Jönköping, Sweden, 551 85
Karolinska University Hospital, Solna Studiebehandlingsenheten, B8:09 Recruiting
Solna, Sweden, 171 64
Lanssjukhuset Sundsvall-Harnöoand Onkologkliniken Sundsvall Recruiting
Sundsvall, Sweden, 856 43
Norrlands Universitetssjukhus Cancercentrum Umea Recruiting
Umeå, Sweden, 901 85
Akademiska sjukhuset Onkologmottagningen Recruiting
Uppsala, Sweden, 75185
Universitetssjukhuset Orebro Recruiting
Örebro, Sweden, 701 85
Ukraine
Cherkasy Regional Oncological Dispensary Regional Clinical Oncological Centre Recruiting
Cherkasy, Ukraine, 18009
Dnipro Regional Oncology Dispensary Recruiting
Dnipro, Ukraine, 49055
Institute of Medical Radiology of S.P. Grygoryev of AMS UKR Recruiting
Kharkiv, Ukraine, 61024
Kharkiv Regional Oncology Center Recruiting
Kharkiv, Ukraine, 61070
National Institute of Cancer Abdominal Oncology Department Recruiting
Kyiv, Ukraine, 03022
Kyiv City Clinical Oncology Centre Chemotherapy Department #2 Recruiting
Kyiv, Ukraine, 03115
Lviv Regional Oncology Center Chemotherapy department Recruiting
Lviv, Ukraine, 79031
Odesa Regional Oncology Dispensary Day patient Department Recruiting
Odesa, Ukraine, 65010
Podillia Regional Oncology Centre Chemotherapy Department Recruiting
Vinnytsya, Ukraine, 21029
United Kingdom
Aberdeen Royal Infirmary Oncology Department Recruiting
Aberdeen, United Kingdom, AB25 2ZN
University Hospitals Bristol Bristol Haematology & Oncology Centre Recruiting
Bristol, United Kingdom, BS2 8ED
St James's University Hospital Recruiting
Leeds, United Kingdom, LS9 7TF
Leicester Royal Infirmary The HOPE Clinical Trials Unit Recruiting
Leicester, United Kingdom, LE1 5WW
Royal Marsden Hospital Department of Medicine Recruiting
London, United Kingdom, SW3 6JJ
Hammersmith Hospital Gary Weston Centre Recruiting
London, United Kingdom, W12 0HS
Sarah Cannon Research Institute UK Clinical Trials Recruiting
London, United Kingdom, W1G 6AD
Christie Hospital NHS Foundation Trust GI & Endocrine Recruiting
Manchester, United Kingdom, M20 4BX
Royal Marsden Hospital Department of Medicine Recruiting
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Institut de Recherches Internationales Servier
ADIR, a Servier Group company
Investigators
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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 ClinicalTrials.gov site

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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    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask for all interventional clinical studies:

  • submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
  • Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.
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/

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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 ):
Metastatic
Cancer
Colorectal
Colorectal Cancer
Colon
Rectum
Metastasis
Additional relevant MeSH terms:
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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