Study of Efficacy and Safety of S 95005 (TAS-102) in Patients With Metastatic Colorectal Cancer Who Failed Standard Chemotherapies

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of S 95005 in patients with metastatic colorectal cancer (mCRC) who are refractory or intolerant to standard chemotherapies in terms of Progression-Free Survival rate at 2 months in the Russian population.

Official Title
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Open-label Multicentre Confirmatory Study of Efficacy and Safety of S 95005 (TAS-102) in Patients With Metastatic Colorectal Cancer Who Are Refractory or Intolerant to Standard Chemotherapies

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Drug: S95005


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged ≥18 years of age Has definitive histologically or cytologically confirmed adenocarcinoma of the colon or rectum 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 Has Eastern Cooperative Group (ECOG) performance status of 0 or 1 Has at least one measurable metastatic lesion(s) Has adequate organ function 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: Pregnancy, breastfeeding Participation in another interventional study within 4 weeks prior to inclusion; participation in non-interventional registries or epidemiological studies is allowed Has previously received S95005 or history of allergic reaction attributed to compounds of similar composition to S95005 Has a serious illness or medical condition(s) as described in the protocol Has had certain other recent treatment e.g. major surgery, field radiation, anticancer therapy, within the specified time frames prior to inclusion Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 attributed to any prior therapies.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S95005<br>Film-coated tablet containing 15 mg of trifluridine and 7.065 mg of tipiracil hydrochloride, or 20 mg of trifluridine and 9.42 mg of tipiracil hydrochloride (with a molar ratio of 1:0.5) was administered at 35 mg/m²/dose orally twice a day, within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period. This treatment cycle was repeated every 4 weeks until treatment withdrawal criteria are met. | Drug: S95005<br>* The treatment is given in open manner. It was administered until unacceptable toxicity according to the investigator, disease progression or patient withdrawal. If a patient discontinues study treatment for reasons other than radiologic disease progression (e.g., intolerable side effects), the patient was followed for tumour response until radiologic disease progression or initiation of new anticancer therapy (whichever occurs first).<br>* Other names: TAS-102;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) rate | percentage of patients alive without investigator-assessed radiological disease progression according to RECIST 1.1 after 2 months | at 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS). | based on Investigator review of the images according to RECIST 1.1 | Through study completion, an average of 12 weeks | 
| Overall Response Rate (ORR). | based on Investigator review of the images according to RECIST 1.1 | Through study completion, an average of 12 weeks | 
| Disease Control Rate (DCR) | based on Investigator review of the images according to RECIST 1.1 | Through study completion, an average of 12 weeks | 
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] |  | Through study completion, an average of 12 weeks | 
| Abnormalities in laboratory tests (haematology, blood biochemistry and urinalysis) [safety and tolerability] |  | Through study completion, an average of 12 weeks | 
| Abnormalities in physical examination and performance status (ECOG) [safety and tolerability] |  | Through study completion, an average of 12 weeks | 
| Abnormalities in blood pressure [safety and tolerability] |  | Through study completion, an average of 12 weeks | 
| Abnormalities in heart rate [safety and tolerability] |  | Through study completion, an average of 12 weeks | 
| Abnormalities in body temperature [safety and tolerability] |  | Through study completion, an average of 12 weeks | 
| Abnormalities in respiration rate [safety and tolerability] |  | Through study completion, an average of 12 weeks | 
| Abnormalities in body weight [safety and tolerability] |  | Through study completion, an average of 12 weeks | 
| Abnormalities in 12-leads ECG parameters [safety and tolerability] |  | Through study completion, an average of 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic, colorectal, cancer, Lonsurf, S95005, Russia