Status:
COMPLETED
Study of Efficacy and Safety of S 95005 (TAS-102) in Patients With Metastatic Colorectal Cancer Who Failed Standard Chemotherapies
Lead Sponsor:
Institut de Recherches Internationales Servier
Collaborating Sponsors:
ADIR, a Servier Group company
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 Progressio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2018
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03274882
Start Date
March 3 2017
End Date
December 3 2018
Last Update
July 25 2024
Active Locations (2)
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1
Russian Cancer Research Center n.a. NN Blokhin (RCRC), Clinical Pharmacology and Chemotherapy department
Moscow, Russia, 115478
2
Saint Petersburg Clinical Scientific-Practical Center of Special Medical Care (Oncology Center)
Saint Petersburg, Russia, 197758