Study of efficacy and safety of S 95005 (TAS-102) in patients with metastatic colorectal cancer who failed standard chemotherapies

ISRCTN	ISRCTN14228310
DOI	https://doi.org/10.1186/ISRCTN14228310
ClinicalTrials.gov number	NCT03274882
Secondary identifying numbers	CL2-95005-003

Submission date: 22/09/2016
Registration date: 02/11/2016
Last edited: 02/01/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Vladimir Moiseenko
Scientific

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

Study information

Study design	Multi-centre open-label single-arm study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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 objectives	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(s)	Ethical Counsil at Ministry of Healthcare of Russian Federation, 09/08/2016, ref: 4017917-20-1
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	04/07/2016
Completion date	03/12/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	26
Total final enrolment	26
Key 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
Key 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)
Date of first enrolment	23/01/2017
Date of final enrolment	23/07/2017

Locations

Countries of recruitment

Russian Federation

Study participating centres

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

Moscow
115478
Russian Federation

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

Saint Petersburg
197758
Russian Federation

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

Moscow
115478
Russian Federation

Sponsor information

Institut de Recherche Internationales Servier (IRIS)
Industry

50 rue Carnot
Suresnes
92284
France

Website	https://clinicaltrials.servier.com/
"ROR"	https://ror.org/034e7c066

Funders

Funder type

Industry

ADIR

No information available

Results and Publications

Intention to publish date	31/12/2019
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
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 plan	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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results				No	No
Plain English results				No	Yes
Results article	results	01/07/2019	02/01/2020	Yes	No

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.