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-BE

Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary: Not available

Detailed Description: Not available

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

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Between the date of randomization and the date of death due to any cause;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)<br>- Overall response rate (ORR)<br>- Disease control rate (DCR)<br>- Safety and tolerability<br>- Quality of life (QoL);Primary end point(s): Overall Survival

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Progression free survival<br>- Overall response rate<br>- Disease control rate<br>- Safety/tolerability<br>- Quality of life;Timepoint(s) of evaluation of this end point: - PFS: inclusion period then every two cycles<br>- ORR: inclusion period then every two cycles<br>- DCR: inclusion period then every two cycles<br>- Safety/tolerability: all over the study period<br>- QoL: inlusion period then every subsequent cycles at day 1

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