Metastatic colorectal cancer Cancer Colorectal cancer
Conditions
Interventions
Single arm study where film-coated tablets of S95005 containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride, are given or
Sponsors
Institut de Recherche Internationales Servier (IRIS)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged =18 years of age 2. Has definitive histologically or cytologically confirmed adenocarcinoma of the colon or rectum 3. Has received at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer (including fluoropyrimidines, irinotecan and oxaliplatin and, if accessible, an anti-VEGF monoclonal antibody and at least one of the anti-EGFR monoclonal antibodies for RAS wild-type patients (if RAS mutation status was evaluated)) and was refractory or intolerant to those chemotherapies 4. Has Eastern Cooperative Group (ECOG) performance status of 0 or 1 5. Has at least one measurable metastatic lesion(s) 6. Has adequate organ function 7.Women of childbearing potential must have been tested negative in a serum pregnancy test within 3 days prior to inclusion 8. 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
Exclusion criteria
Exclusion criteria: 1. Pregnancy, breastfeeding 2, Has previously received S 95005 or history of allergic reaction attributed to compounds of similar composition to S 95005 3. Has certain serious illnesses or medical conditions 4. Has had certain other recent treatment e.g. major surgery, field radiation, anticancer therapy, within the specified time frames prior to inclusion 5. Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 attributed to any prior therapies (excluding anaemia, alopecia, skin pigmentation, and platinum-induced neurotoxicity)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) rate at 2 months (percentage of patients alive without investigator-assessed radiological disease progression according to RECIST 1.1 after 2 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Antitumor activity (Progression-Free Survival, Overall Response Rate, Disease Control Rate) based on Investigator review of the images according to RECIST 1.1, within 28 days prior to Day 1 of Cycle 1 and every 8 weeks thereafter. 2. Safety and tolerability, at each visit, from the informed consent signature to the withdrawal visit , assessed by: 2.1. Incidence of Adverse Events 2.2. Laboratory tests: haematology, blood biochemistry and urinalysis 2.3. Physical examination and performance status (ECOG) 2.4. Vital signs: blood pressure, heart rate, body temperature, respiration rate, body weight 2.5. 12-leads ECG parameters (only at baseline and at withdrawal visit) | — |
Countries
Russian Federation
Outcome results
None listed