Condition category
Cancer
Date applied
22/09/2016
Date assigned
02/11/2016
Last edited
18/10/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Vladimir Moiseenko

ORCID ID

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
197758
Russian Federation

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CL2-95005-003

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

Acronym

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

Interventional

Secondary study design

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Metastatic colorectal cancer

Intervention

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

Drug

Phase

Drug names

Primary outcome measures

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

04/07/2016

Overall trial end date

08/12/2017

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

Target number of participants

26

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

23/01/2017

Recruitment end date

23/07/2017

Locations

Countries of recruitment

Russian Federation

Trial participating centre

Russian Cancer Research Center n.a. NN Blokhin (RCRC)
Moscow
115478
Russian Federation

Trial participating centre

Saint Petersburg Clinical Scientific-Practical Center of Special Medical Care (Oncology Center)
Saint Petersburg
197758
Russian Federation

Trial participating centre

Russian Cancer Research Center n.a. NN Blokhin (RCRC)
Moscow
115478
Russian Federation

Sponsor information

Organisation

Institut de Recherche Internationales Servier

Sponsor details

50 rue Carnot
Suresnes
92284
France

Sponsor type

Industry

Website

http://www.servier.com/

Funders

Funder type

Industry

Funder name

ADIR

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Will comply with regulatory requirements

IPD sharing statement:
Participant level data will be available on request after Marketing Authorisation has been granted

Intention to publish date

08/12/2018

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/10/2017: Internal review. 20/03/2017: Ethics approval information added.