Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy.
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Progression-free Survival (PFS) — 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.
Trial sites (190)
| 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.
More Institut de Recherches Internationales Servier trials in Denmark
Other trials for the same condition
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 Denmark