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: Recruiting
• First Posted: March 11, 2019
• Last Update Posted: January 23, 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)
• 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

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

Contacts

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

Locations

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

• 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: 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/

• 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