A study of trifluridine/tipiracil and bevacizumab in patients with resistant colorectal cancer that has spread (metastatic)

Phase 1

• Conditions: Refractory metastatic colorectal cancer; MedDRA version: 21.0Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-001976-14-AT
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-08
• Last Update Posted: 30 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 492

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified