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A Study of Trifluridine/Tipiracil (Also Known as S 95005 or TAS-102) in Patients With a Pretreated Colorectal Cancer That Has Spread (Metastatic). (PRECONNECT)

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Servier Protocol Code: CL3-95005-004 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT03306394 EudraCT Number: 2016-002311-18

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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 99 locations

Study description

The study drug is a combination of two drugs: trifluridine and tipiracil. It is called S95005 or TAS-102.

S95005 (trifluridine + tipiracil) is marketed in several countries around the world. It is used to treat patients with gastric or colorectal cancer that has spread to other parts of the body when standard treatments are no longer effective.

It is a drug that blocks the growth of cancer cells.

The present study is an early access study. The aim was for patients with colorectal cancer to gain access to S95005 before it was marketed in the patient’s country.

This study is a Phase IIIb study. The purpose was to obtain more data on a drug.

The main objective of the study was to have more safety data on the study drug.

Official title: An Open-label Early Access Phase IIIb Study of Trifluridine / Tipiracil (S 95005/TAS-102) in Patients With a Pretreated Metastatic Colorectal Cancer (PRECONNECT)
Conditions
Metastatic Colorectal Cancer
Interventions / Treatments
  • Trifluridine/Tipiracil hydrochloride (S95005)
Other study id numbers
  • CL3-95005-004

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 a colorectal cancer.
  • Have a cancer that had spread to other parts of the body.
  • Have previously been treated for colorectal cancer.
  • Not be able to use standard treatments.

Participants could not take part in the study if:

  • They had previously received trifluridine or tipiracil.
  • Their cancer had spread to the brain.

How is the study designed?

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

All participants received the study drug as tablets, at the dose of 35 milligrams per square meter (m²) of body surface area. This means that the dose depends on the size of the participant’s body. Participants took the study drug during time periods called “cycles”. A cycle lasted 28 days.

Intervention / Treatment
Drug: Trifluridine/Tipiracil hydrochloride (S95005)

Keywords

Provided by Servier
metastatic colorectal cancer trifluridine/tipiracil early access
Additional Relevant MeSH Terms Glioma
Colorectal Neoplasms Neoplasm Metastasis Neoplasms