🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Germany / NCT03869892
Active, not recruiting Phase 3

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

NCT03869892 · tracked via the Priya Life Science Germany tracker
Phase
Phase 3
Started
2019-03-21
Last updated
2025-12-22

Condition(s) studied

Metastatic Colorectal Cancer

Investigational drug(s) / intervention(s)

Trifluridine/tipiracil hydrochloride (S95005) →Capecitabine →Bevacizumab experimentalBevacizumab control

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

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

Trial sites (190)

FacilityCityRegionStatus
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 Germany

Other trials for the same condition

Official registry record

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