Contact information
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
NCT03274882
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
Non randomised study
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
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
04/07/2016
Overall trial end date
03/12/2018
Reason abandoned (if study stopped)
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
Total final enrolment
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 (IRIS)
Sponsor details
50 rue Carnot
Suresnes
92284
France
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
ADIR
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Summary results and a lay summary will be published on https://clinicaltrials.servier.com/ 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 https://clinicaltrials.servier.com/ after the Marketing Authorisation has been granted.
Intention to publish date
31/12/2019
Participant level data
To be made available at a later date
Basic results (scientific)
https://clinicaltrials.servier.com/wp-content/uploads/CL2-95005-003-anonymised-synopsis.pdf
Publication list
2019 results in https://doi.org/10.1093/annonc/mdz155.057 (added 02/01/2020)