The main purpose of this study is to demonstrate the superiority of S 95005 in combination with bevacizumab over capecitabine in combination with bevacizumab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
856
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.
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.
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.
Progression-free Survival (PFS)
Time elapsed between the randomization and the date of radiological tumour progression (according to RECIST 1.1) or death from any cause.
Time frame: Up to 24 months
Overall Survival (OS)
Time elapsed between the date of randomization and the date of death due to any cause.
Time frame: Up to 8 years
Overall response rate (ORR)
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.
Time frame: Up to 8 years
Disease control rate (DCR)
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.
Time frame: Up to 8 years
Duration of response (DoR)
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.
Time frame: Up to 8 years
Time to treatment failure (TTF)
The time from randomization to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death.
Time frame: Up to 8 years
Incidence of Adverse Events (AEs)
Time frame: Up to 8 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
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
...and 180 more locations
Number of clinically significant changes to hematology, biochemistry, coagulation and urinalysis tests
Time frame: Up to 8 years
Changes in ECOG performance status
Time frame: Up to 8 years
Number of clinically significant changes to blood pressure, heart rate, body temperature and body weight
Time frame: Up to 8 years
Number of clinically significant changes to 12-leads ECG parameters
Time frame: Up to 8 years
Quality of life as assessed by EORTC QLQ-C30
European organization for research and treatment of cancer (EORTC) Quality of Life Questionnaire - Core Questionnaire (QLQ-C30) scores range from 0-100 and assess functional and symptom scores. For functional scores, a higher score represents an increase in functioning. For symptom scores, a higher score represents an increase in symptoms.
Time frame: Up to 8 years
Quality of life as assessed by EQ-5D-5L
The 5-level EQ-5D version questionnaire scores range from 5 to 25 with a higher score representing a worse health status.
Time frame: Up to 8 years