An open-label, randomised, phase III study comparing trifluridine/tipiracil in combination with bevacizumab to trifluridine/tipiracil monotherapy in patients with refractory metastatic colorectal cancer

Institut de Recherches Internationales Servier0 sites492 target enrollmentStarted: September 8, 2020Last updated: October 30, 2023

Drugs

Trial Snapshot

No summary available.

•- 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
•- Is able to swallow oral tablets
•- Estimated life expectancy =12 weeks
•- 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

•- Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease
•- Has had certain other recent treatment e.g. major surgery, field radiation, received investigational agent, within the specified time frames prior to randomisation.
•- Has hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
•- Has certain serious illness or serious medical condition(s) described in
•the protocol.
•- Is inappropriate for entry into this study in the judgment of the Investigator.

Sponsor