Clinical Trials Directory

Trials / Completed

CompletedNCT03274882

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

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
26 (actual)
Sponsor
Institut de Recherches Internationales Servier · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGS95005The 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).

Timeline

Start date
2017-03-03
Primary completion
2017-12-31
Completion
2018-12-03
First posted
2017-09-07
Last updated
2024-07-25

Locations

2 sites across 1 country: Russia

Source: ClinicalTrials.gov record NCT03274882. Inclusion in this directory is not an endorsement.