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Be Part of Research - Trial Details - Study of S 95005 in Combination With Oxaliplatin in Metastatic Colorectal Cancer
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Study of S 95005 in Combination With Oxaliplatin in Metastatic Colorectal Cancer

Completed

Open to: ALL

Age: 18.0 - N/A

Manchester

Medical Conditions

Colorectal Neoplasms

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The main purpose of this study is to assess the safety and tolerability and to determine the recommended phase 2 dose of S 95005 given in combination with oxaliplatin in patients with metastatic colorectal cancer.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

May 2016 Aug 2019

Publications

"Bordonaro R, Calvo A, Auriemma A, Hollebecque A, Rubovszky G, Saunders MP, Papai Z, Prager G, Stein A, Andre T, Argiles G, Cubillo A, Dahan L, Edeline J, Leger C, Cattan V, Fougeray R, Amellal N, Tabernero J. Trifluridine/tipiracil in combination with oxaliplatin and either bevacizumab or nivolumab in metastatic colorectal cancer: a dose-expansion, phase I study. ESMO Open. 2021 Oct;6(5):100270. doi: 10.1016/j.esmoop.2021.100270. Epub 2021 Sep 20."; "34547581"; "Argiles G, Andre T, Hollebecque A, Calvo A, Dahan L, Cervantes A, Leger C, Amellal N, Fougeray R, Tabernero J. Phase I dose-escalation of trifluridine/tipiracil in combination with oxaliplatin in patients with metastatic colorectal cancer. Eur J Cancer. 2019 May;112:12-19. doi: 10.1016/j.ejca.2019.01.101. Epub 2019 Mar 16."; "30889492"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride, given orally at the dose of 25 or 30 or 35 mg/m2/dose, until unacceptable toxicity according to the investigator, disease progression or patient withdrawal.

Intervention Arm Group : S 95005 + oxaliplatin (+/- bevacizumab or nivolumab);

Intervention Type : DRUG
Intervention Description : Concentrate for solution for infusion containing 5mg/ml of oxaliplatin, administered intravenously at the dose of 65 to 85 mg/m2, until unacceptable toxicity according to the investigator, disease progression or patient withdrawal.

Intervention Arm Group : S 95005 + oxaliplatin (+/- bevacizumab or nivolumab);

Intervention Type : DRUG
Intervention Description : Concentrate for solution for infusion containing 25mg/ml of bevacizumab, administered intravenously at the dose of 5 mg/kg, until unacceptable toxicity according to the investigator, disease progression or patient withdrawal.

Intervention Arm Group : S 95005 + oxaliplatin (+/- bevacizumab or nivolumab);

Intervention Type : DRUG
Intervention Description : Concentrate for solution for infusion containing 10mg/ml of nivolumab, administered intravenously at the dose of 3 mg/kg, until unacceptable toxicity according to the investigator, disease progression or patient withdrawal.

Intervention Arm Group : S 95005 + oxaliplatin (+/- bevacizumab or nivolumab);



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Christie Hospital NHS Foundation Trust GI & Endocrine
    Manchester
    M20 4BX


The study is sponsored by Institut de Recherches Internationales Servier and is in collaboration with ADIR, a Servier Group company.



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Read full details for Trial ID: NCT02848443
Last updated 24 July 2024

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