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.
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.
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.
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.
The main purpose of this study is to demonstrate the superiority of S 95005 in combination with bevacizumab over capecitabine in combination with bevacizumab.
| Facility | City | Region | Status |
|---|---|---|---|
| Centro de Oncología e Investigación de Buenos Aires COIBA | Berazategui | Argentina | |
| Hospital de Gastroenterología Dr. Carlos Borino Udaondo Oncology Unit | Buenos Aires | Argentina | |
| Fundación Favaloro Oncology Unit | Buenos Aires | Argentina | |
| Instituto Alexander Fleming | Buenos Aires | Argentina | |
| Hospital Universitario CEMIC Servicio de Oncología, Unidad de tumores gastrointestinales | Buenos Aires | Argentina | |
| Centro Oncológico Riojano Integral CORI Fundación CORI para la Investigación y Prevención del Cáncer | La Rioja | Argentina | |
| Fundación COIR Centro Oncológico de Interación Regional | Mendoza | Argentina | |
| Centro Médico San Roque | San Miguel de Tucumán | Argentina | |
| Instituto de Oncología de Rosario | Santa Fe | Argentina | |
| ISIS Centro especializado | Santa Fe | Argentina | |
| Blacktown Hospital Cancer and Haematology Centre | Blacktown | Australia | |
| Frankston Private Peninsula and Southeast Oncology Group | Frankston | Australia | |
| Lake Macquarie Private Hospital | Gateshead | Australia | |
| St George Hospital St George Hospital Cancer Care Centre | Kogarah | Australia | |
| Adventist HealthCare Integrated Cancer Centre | Wahroonga | Australia | |
| Southern Medical Day Care Centre | Wollongong | Australia | |
| Med. Universität Graz Klinische Abteilung für Onkologie | Graz | Austria | |
| Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin V | Innsbruck | Austria | |
| Ordensklinikum Linz Barmherzige Schwestern Interne I | Linz | Austria | |
| Landeskrankenhaus (SALK) Universitätsklinik für Innere Medizin III (SALK) | Salzburg | Austria | |
| Universitätsklinikum St. Pölten Klinische Abteilung für Innere Medizin I | Sankt Pölten | Austria | |
| Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie | Vienna | Austria | |
| Hospital do Câncer de Barretos - Fundação Pio XII Unidade de Pesquisa Clínica | Barretos | Brazil | |
| Cenantron - Clinica | Belo Horizonte | Brazil | |
| Sirio Libanes DF - Centro de Oncologia de Braslia do Sirio- Centro Intergrado de Pesquisa | Brasília | Brazil | |
| Centro de Pesquisa Hospital de Caridade de Ijuí Unidade de Pesquisa Clínica | Ijuí | Brazil | |
| Hospital Mae de Deus Oncologia | Porto Alegre | Brazil | |
| Hospital São Rafael Centro Intergrado de Pesquisa | Salvador | Brazil | |
| CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncol Centro Intergrado de Pesquisa | Santo André | Brazil | |
| Hospital de Base Centro Integrado de Pesquisa | São José do Rio Preto | Brazil | |
| ICESP - Instituto do Câncer do Estado de São Paulo Centro Integrado de Pesquisa | São Paulo | Brazil | |
| Hospital A C Camargo Unidade de Pesquisa Clinica | São Paulo | Brazil | |
| "Complex oncology center - Burgas" EOOD Department of medical oncology | Burgas | Bulgaria | |
| "Multiprofile hosp. for active treatmen Dr. Tota Venkova" AD Department of medical oncology | Gabrovo | Bulgaria | |
| "Complex oncology center - Plovdiv" EOOD, IInd base Dpt. of Med. oncology and onc. diseases in gastroenterology | Plovdiv | Bulgaria | |
| "Medical Center Nadezhda Clinical" EOOD Medical Oncology Department | Sofia | Bulgaria | |
| "UMHAT Sv. Ivan Rilski" EAD Clinic of clinical hematology, Dpt. of medical oncology | Sofia | Bulgaria | |
| MHAT Serdika EOOD Department of Medical Oncology | Sofia | Bulgaria | |
| Spec. hospital for active treatment of oncology dis. EOOD Department of medical oncology and palliative care | Sofia | Bulgaria | |
| SHAT of oncology diseases Dr. Marko Antonov Markov" EOOD Department of medical oncology and palliative therapy | Varna | Bulgaria |
+ 150 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03869892 on ClinicalTrials.gov ↗ ← All trials in Germany