Refractory metastatic colorectal cancer MedDRA version: 21.0 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Institut de Recherches Internationales Servier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Has histologically confirmed unresectable adenocarcinoma of the colon or rectum - RAS status must have been previously determined (mutant or wild-type) based on local assessment of tumour biopsy - Has received a maximum of 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen - Has measurable or non-measurable disease as defined by RECIST version 1.1 - Has an Eastern Cooperative Oncology Group (ECOG) performance status =1. ECOG should remain=1 during all the screening period - Has adequate organ function Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 270 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 220
Exclusion criteria
Exclusion criteria: - Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of trifluridine/tipiracil in combination with bevacizumab over trifluridine/tipiracil monotherapy in terms of Overall Survival (OS) in patients with refractory metastatic colorectal cancer (mCRC).;Secondary Objective: - Progression-free survival (PFS) - Overall response rate (ORR) - Disease control rate (DCR) - Safety and tolerability - Quality of life (QoL);Primary end point(s): Overall Survival ;Timepoint(s) of evaluation of this end point: Between the date of randomization and the date of death due to any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Progression free survival - Overall response rate - Disease control rate - Safety/tolerability - Quality of life;Timepoint(s) of evaluation of this end point: - PFS: inclusion period then every two cycles - ORR: inclusion period then every two cycles - DCR: inclusion period then every two cycles - Safety/tolerability: all over the study period - QoL: inlusion period then every subsequent cycles at day 1 | — |
Countries
Austria, Belgium, Brazil, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Russian Federation, Spain, Ukraine
Contacts
Public ContactClinical Studies Department
Institut de Recherches Internationales Servier
Outcome results
None listed