EUCTR2020-001976-14-DEActive, not recruitingPhase 1
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: July 23, 2020Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 492
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •- 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
Exclusion Criteria
- •- 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.
Investigators
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