Study of Efficacy and Safety of S 95005 (TAS-102) in Patients With Metastatic Colorectal Cancer Who Failed Standard Chemotherapies
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
2 other identifiers
interventional
26
1 country
2
Brief Summary
The purpose of this study is to evaluate the efficacy of S 95005 in patients with metastatic colorectal cancer (mCRC) who are refractory or intolerant to standard chemotherapies in terms of Progression-Free Survival rate at 2 months in the Russian population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2017
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 3, 2017
CompletedFirst Submitted
Initial submission to the registry
August 2, 2017
CompletedFirst Posted
Study publicly available on registry
September 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 3, 2018
CompletedJuly 25, 2024
July 1, 2024
10 months
August 2, 2017
July 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival (PFS) rate
percentage of patients alive without investigator-assessed radiological disease progression according to RECIST 1.1 after 2 months
at 2 months
Secondary Outcomes (12)
Progression-Free Survival (PFS).
Through study completion, an average of 12 weeks
Overall Response Rate (ORR).
Through study completion, an average of 12 weeks
Disease Control Rate (DCR)
Through study completion, an average of 12 weeks
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Through study completion, an average of 12 weeks
Abnormalities in laboratory tests (haematology, blood biochemistry and urinalysis) [safety and tolerability]
Through study completion, an average of 12 weeks
- +7 more secondary outcomes
Study Arms (1)
S95005
EXPERIMENTALFilm-coated tablet containing 15 mg of trifluridine and 7.065 mg of tipiracil hydrochloride, or 20 mg of trifluridine and 9.42 mg of tipiracil hydrochloride (with a molar ratio of 1:0.5) was administered at 35 mg/m²/dose orally twice a day, within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period. This treatment cycle was repeated every 4 weeks until treatment withdrawal criteria are met.
Interventions
The treatment is given in open manner. It was administered 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), the patient was followed for tumour response until radiologic disease progression or initiation of new anticancer therapy (whichever occurs first).
Eligibility Criteria
You may qualify if:
- Male or female aged ≥18 years of age
- Has definitive histologically or cytologically confirmed adenocarcinoma of the colon or rectum
- 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
- Has Eastern Cooperative Group (ECOG) performance status of 0 or 1
- Has at least one measurable metastatic lesion(s)
- Has adequate organ function
- 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
You may not qualify if:
- Pregnancy, breastfeeding
- Has previously received S95005 or history of allergic reaction attributed to compounds of similar composition to S95005
- Has a serious illness or medical condition(s) as described in the protocol
- Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 attributed to any prior therapies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Russian Cancer Research Center n.a. NN Blokhin (RCRC), Clinical Pharmacology and Chemotherapy department
Moscow, 115478, Russia
Saint Petersburg Clinical Scientific-Practical Center of Special Medical Care (Oncology Center)
Saint Petersburg, 197758, Russia
Related Publications (1)
Fedyanin M, Chekini D, Chubenko V, Tjulandin S, Zhabina A, Amellal N, Aubel P, Gandossi E, Moiseenko V. Trifluridine/tipiracil safety and efficacy in Russian patients with metastatic colorectal cancer and refractory or intolerant to standard chemotherapies: Results of the primary analysis. Ann Oncol. 2019 Jul;30(Supplement 4):IV16. doi: 10.1093/annonc/mdz155.057
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vladimir MOISEENKO, Prof.
Saint Petersburg Clinical Scientific-Practical Center of Specialized Medical Care (Oncological)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2017
First Posted
September 7, 2017
Study Start
March 3, 2017
Primary Completion
December 31, 2017
Study Completion
December 3, 2018
Last Updated
July 25, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After Marketing Authorisation in EEA or US if the study is used for the approval.
- Access Criteria
- Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs). They can ask all interventional clinical studies: * submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.