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Home » Find Clinical Trials » Study of S 95005 in Combination With Oxaliplatin in Metastatic Colorectal Cancer

Study of S 95005 in Combination With Oxaliplatin in Metastatic Colorectal Cancer

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Servier Protocol Code: CL1-95005-001 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT02848443 EudraCT Number: 2015-004894-34

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How to participate in this 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 can’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 24 locations

Study description

S95005, also named trifluridine/tipiracil, is a drug already marketed in some countries. It is used to treat patients with gastric, colon or rectal cancer that has spread to other parts of the body when standard treatments are no longer effective.

The purpose of this study was to test whether S95005 combined with other anticancer drugs would help people with colon and rectal cancer that has spread after previously receiving chemotherapy. The anticancer medicines combined with S95005 were oxaliplatin, and then either bevacizumab or nivolumab:

  • S95005 and oxaliplatin are drugs that block the growth of cancer cells.
  • Bevacizumab is a drug that blocks the blood vessels which provide blood to the tumour. It slows the growth of the tumour.
  • Nivolumab helps the immune system fight tumour cells.

This study was done in 2 parts. In part 1, S95005 was combined with another marketed drug called oxaliplatin. In part 2, a third marketed drug, either bevacizumab or nivolumab, was added.

The main objectives of this study were:

  • To look at the safety of S95005 given in combination with oxaliplatin.
  • To find out the highest tolerated dose of S95005 when taken together with oxaliplatin.

One objective of part 2 of the study was to evaluate how S95005 given in combination with oxaliplatin + bevacizumab or nivolumab works on colon and rectal cancer.

Official title: Phase I Dose-escalation of S 95005 (TAS-102) in Combination With Oxaliplatin in Metastatic Colorectal Cancer
Results
English (USA)
Conditions
Metastatic Colorectal Cancer
Interventions / Treatments
  • Trifluridine/tipiracil hydrochloride (S 95005)
  • Oxaliplatin
  • Bevacizumab
  • Nivolumab
Other study id numbers
  • CL1-95005-001

Eligibility Criteria

Eligible age for the study

18 years and older (Adult, Older Adult)

Sex

Male/Female

Accepts Healthy Volunteers

No

To participate in the study, participants had to:

  • Be 18 years of age or older.
  • Have been diagnosed with colorectal cancer that had spread to other parts of the body.
  • Have previously been treated with at least one cancer therapy and did not receive oxaliplatin for their cancer.

Participants could not take part in the study if:

  • They had another type of cancer within 3 years before starting the study.
  • 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 + oxaliplatin (+/- bevacizumab or nivolumab)
Intervention / Treatment
Drug: S95005 + oxaliplatin (+/- bevacizumab or nivolumab)

All participants received S95005 tablets orally and oxaliplatin by an infusion (injection given slowly) into a vein. Those participating in part 2 also received bevacizumab or nivolumab given by an infusion into a vein.

Keywords

Provided by Servier
metastatic colorectal cancer oxaliplatin dose-escalation Lonsurf nivolumab bevacizumab
Additional Relevant MeSH Terms Glioma
Colorectal Neoplasms Neoplasm Metastasis Neoplasms