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

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Servier Protocol Code: CL2-95005-003 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT03274882

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How to participate to the study?
If you think you are eligible for this study (see
eligibility criteria
below), you can identify the location closest to you and contact them directly. If you don’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00
The study has 2 locations

Study description

This study was done to test a medicine called S95005 or TAS-102 in patients with colorectal cancer. Colorectal cancer is a cancer of parts of the large intestine. It is also known as bowel cancer, colon cancer or rectal cancer.

The study drug (S95005) is a combination of two drugs: trifluridine and tipiracil. It is a drug that blocks cancer cells from multiplying. This drug is already used to treat patients with colorectal cancer that has spread to other parts of the body when standard treatments are no longer effective.

A previous study called RECOURSE showed the efficacy of S95005 in Japanese, American and European populations but did not include a Russian population.

The main goal of the study was to see how effective is S95005 in the Russian patients with colorectal cancer who did not respond to or could not tolerate the standard treatments.

Official title: 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
Results
English (USA)
English (USA)
Conditions
Metastatic Colorectal Cancer
Interventions / Treatments
  • S95005
Other study id numbers
  • CL2-95005-003

Eligibility Criteria

Eligible age for the study

18 years and older (Adult, Older Adult)

Sexes

Male/Female

Accepts Healthy Volunteers

No

To take part in the study, participants had to:

  • Be at least 18 years old.
  • Have been diagnosed with colorectal cancer that had spread to other parts of the body (metastatic).
  • Have a cancer for which standard treatments cannot be used anymore.

Participants could not take part in the study if:

  • Their cancer had spread to the brain.
  • They had any major surgery within 4 weeks or any anticancer therapy within 3 weeks before starting the study.

How is the study designed?

Allocation
N/A
Interventional study model
Single Group
Participant Group / Arm
Experimental: S95005

All participants took the combination of trifluridine plus tipiracil in time periods called “cycles”. One cycle lasted 28 days. Participants took the study drug orally twice a day, 5 days per week, for 2 weeks. Then, there was 2 weeks without treatment. Cycles were repeated until the cancer progressed or the participant experienced too severe side effects.

Intervention / Treatment
Drug: S95005

Keywords

Provided by Servier
metastatic colorectal cancer Lonsurf S95005 Russia
Additional Relevant MeSH Terms Glioma
Colorectal Neoplasms Neoplasm Metastasis Neoplasms