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

• Status: Completed
• Trial end date: 2018-12-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut de Recherches Internationales Servier
• Collaborator: ADIR, a Servier Group company
• Treatments: Trifluridine

Criteria

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.