An early access study of trifluridine / tipiracil (S 95005/TAS-102) in patients with a pretreated metastatic colorectal cancer.

Phase 1

• Conditions: MedDRA version: 19.0Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Metastatic colorectal cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-002311-18-BE
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-04
• Last Update Posted: 28 August 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

- Male or Female participant aged =18 years old
- Has definitive histologically confirmed adenocarcinoma of the colon or rectum
- Has metastatic lesion(s).
- Has received at least 2 prior regimens of standard chemotherapies (including fluoropyrimidines, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and at least one of the anti-EGFR monoclonal antibodies for RAS wild-type patients) for mCRC and is refractory or intolerant to those chemotherapies or is not candidate for those chemotherapies
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 during the screening period
- Is able to take medications orally (i.e., no feeding tube).
- Has adequate organ function
- Women of childbearing potential must have been tested negative in a serum pregnancy test within 7 days prior to first day of test drug administration. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control during the study and for 6 months after the discontinuation of study medication. Women and female partners using hormonal contraceptive must also
use a barrier method.
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 550
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 450

Exclusion Criteria

- Pregnancy, breastfeeding or possibility of becoming pregnant during the study
- Eligible for enrolment into another available ongoing clinical study of trifluridine / tipiracil
- Has previously received trifluridine / tipiracil or hypersensitivity to the active substances or to any of the excipients of trifluridine / tipiracil
- Has rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption
- Has certain serious illness or medical condition(s) described in the protocol
- Has had certain other recent treatment e.g. major surgery, anticancer therapy, radiation therapy, participation in another interventional study, within the specified time frames prior to first day of study drug administration
- Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation, and platinum-induced neurotoxicity).

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to collect additional safety data during treatment with trifluridine / tipiracil in patients with a pretreated mCRC.;Secondary Objective: - Progression free survival (PFS) based on Investigator assessment<br>- Quality of life (QoL) using the questionnaires EQ-5D and EORTC QLQ-C30;Primary end point(s): Safety and tolerability assessed by:<br>- Incidence of Adverse Events <br>- Laboratory tests: haematology, blood biochemistry, urinalysis<br>- Physical examination and performance status (ECOG)<br>- Vital signs: blood pressure, heart rate, body temperature, body weight;Timepoint(s) of evaluation of this end point: Incidence of Adverse Events: all over the study<br>Laboratory tests, physical examination, performance status, vital signs: at baseline, every 4 weeks during study treatment from cycle 2, at withdrawal visit.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Progression free survival (PFS) <br>- Quality of life (QoL) using the questionnaires EQ-5D and EORTC QLQ-C30;Timepoint(s) of evaluation of this end point: - Tumour assessment based on general practices and standard of care of the site.<br>- Quality of Life: at baseline, every 4 weeks during study treatment from cycle 2, at withdrawal visit (if not performed within the previous 4 weeks).