Study of Efficacy and Safety of S 95005 (TAS-102) in Patients With Metastatic Colorectal Cancer Who Failed Standard Chemotherapies
- Registration Number
- NCT03274882
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description S95005 S95005 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Progression-Free Survival (PFS). Through study completion, an average of 12 weeks based on Investigator review of the images according to RECIST 1.1
Overall Response Rate (ORR). Through study completion, an average of 12 weeks based on Investigator review of the images according to RECIST 1.1
Disease Control Rate (DCR) Through study completion, an average of 12 weeks based on Investigator review of the images according to RECIST 1.1
Incidence of Treatment-Emergent Adverse Events [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 laboratory tests (haematology, blood biochemistry and urinalysis) [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 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 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
Trial Locations
- Locations (2)
Russian Cancer Research Center n.a. NN Blokhin (RCRC), Clinical Pharmacology and Chemotherapy department
🇷🇺Moscow, Russian Federation
Saint Petersburg Clinical Scientific-Practical Center of Special Medical Care (Oncology Center)
🇷🇺Saint Petersburg, Russian Federation