Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at the time of registration and not expected to be provided in the future.

Trial website

Contact information



Primary contact

Prof Vladimir Moiseenko


Contact details

Saint Petersburg Clinical Scientific-Practical Center of Special Medical Care (Oncology Center)
Chemotherapy Department
68 A
Lit A
Ulitsa Leningradskaya
Poselok Pesochny
Saint Petersburg
Russian Federation

Additional identifiers

EudraCT number

Nil known number


Protocol/serial number


Study information

Scientific 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


Study hypothesis

To evaluate the efficacy and the safety of S 95005 in patients with metastatic colorectal cancer who are refractory or intolerant to standard chemotherapies

Ethics approval

Ethical Counsil at Ministry of Healthcare of Russian Federation, 09/08/2016, ref: 4017917-20-1

Study design

Multi-centre open-label single-arm study

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Metastatic colorectal cancer


Single arm study where film-coated tablets of S95005 containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride, are given orally twice daily at the dose of 35 mg/m2/dose. The treatment is given 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), patients will be followed for tumour response until radiologic disease progression or initiation of new anticancer therapy (whichever occurs first).

Intervention type



Not Specified

Drug names

Trifluridine + tipiracil hydrochloride (S 95005/TAS-102)

Primary outcome measure

Progression free survival (PFS) rate at 2 months (percentage of patients alive without investigator-assessed radiological disease progression according to RECIST 1.1 after 2 months).

Secondary outcome measures

1. Antitumor activity (Progression-Free Survival, Overall Response Rate, Disease Control Rate) based on Investigator review of the images according to RECIST 1.1, within 28 days prior to Day 1 of Cycle 1 and every 8 weeks thereafter.
2. Safety and tolerability, at each visit, from the informed consent signature to the withdrawal visit , assessed by:
2.1. Incidence of Adverse Events
2.2. Laboratory tests: haematology, blood biochemistry and urinalysis
2.3. Physical examination and performance status (ECOG)
2.4. Vital signs: blood pressure, heart rate, body temperature, respiration rate, body weight
2.5. 12-leads ECG parameters (only at baseline and at withdrawal visit)

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Male or female aged ≥18 years of age
2. Has definitive histologically or cytologically confirmed adenocarcinoma of the colon or rectum
3. Has received at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer (including fluoropyrimidines, irinotecan and oxaliplatin and, if accessible, an anti-VEGF monoclonal antibody and at least one of the anti-EGFR monoclonal antibodies for RAS wild-type patients (if RAS mutation status was evaluated)) and was refractory or intolerant to those chemotherapies
4. Has Eastern Cooperative Group (ECOG) performance status of 0 or 1
5. Has at least one measurable metastatic lesion(s)
6. Has adequate organ function
7.Women of childbearing potential must have been tested negative in a serum pregnancy test within 3 days prior to inclusion
8. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control during the study and for 6 months after the discontinuation of study medication

Participant type


Age group




Target number of participants


Total final enrolment


Participant exclusion criteria

1. Pregnancy, breastfeeding
2, Has previously received S 95005 or history of allergic reaction attributed to compounds of similar composition to S 95005
3. Has certain serious illnesses or medical conditions
4. Has had certain other recent treatment e.g. major surgery, field radiation, anticancer therapy, within the specified time frames prior to inclusion
5. Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 attributed to any prior therapies (excluding anaemia, alopecia, skin pigmentation, and platinum-induced neurotoxicity)

Recruitment start date


Recruitment end date



Countries of recruitment

Russian Federation

Trial participating centre

Russian Cancer Research Center n.a. NN Blokhin (RCRC)
Russian Federation

Trial participating centre

Saint Petersburg Clinical Scientific-Practical Center of Special Medical Care (Oncology Center)
Saint Petersburg
Russian Federation

Trial participating centre

Russian Cancer Research Center n.a. NN Blokhin (RCRC)
Russian Federation

Sponsor information


Institut de Recherche Internationales Servier (IRIS)

Sponsor details

50 rue Carnot

Sponsor type




Funder type


Funder name


Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Summary results and a lay summary will be published on within 12 months after the end of the study.

IPD sharing statement
The datasets generated during and/or analysed during the current study will be available upon request from after the Marketing Authorisation has been granted.

Intention to publish date


Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

2019 results in (added 02/01/2020)

Publication citations

Additional files

Editorial Notes

02/01/2020: The following changes have been made: 1. Publication reference added. 2. The final enrolment number has been added from the reference. 17/12/2019: The following changes have been made: 1. The sponsor website has been updated. 2. The NCT code has been added. 3. The sponsor organisation name has been changed from "Institut de Recherche Internationales Servier" to "Institut de Recherche Internationales Servier (IRIS)". 4. The basic results summary link has been added. 5. The plain English results link has been added. 6. The drug name has been added. 20/12/2018: The overall trial end date has been changed from 31/12/2018 to 03/12/2018. 20/08/2019: Overall trial end date changed from 28/09/2018 to 31/12/2018. 10/04/2018: Publication and dissemination plan and IPD sharing statement updated, overall trial end date changed from 08/12/2017 to 28/09/2018. 20/03/2017: Ethics approval information added.