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Study of Efficacy and Safety of S 95005 (TAS-102) in Patients With Metastatic Colorectal Cancer Who Failed Standard Chemotherapies

Primary Purpose

Metastatic Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
S95005
Sponsored by
Institut de Recherches Internationales Servier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring metastatic, colorectal, cancer, Lonsurf, S95005, Russia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pregnancy, breastfeeding
  • Participation in another interventional study within 4 weeks prior to inclusion; participation in non-interventional registries or epidemiological studies is allowed
  • 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 had certain other recent treatment e.g. major surgery, field radiation, anticancer therapy, within the specified time frames prior to inclusion
  • Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 attributed to any prior therapies.

Sites / Locations

  • Russian Cancer Research Center n.a. NN Blokhin (RCRC), Clinical Pharmacology and Chemotherapy department
  • Saint Petersburg Clinical Scientific-Practical Center of Special Medical Care (Oncology Center)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

S95005

Arm Description

Film-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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Progression-Free Survival (PFS).
based on Investigator review of the images according to RECIST 1.1
Overall Response Rate (ORR).
based on Investigator review of the images according to RECIST 1.1
Disease Control Rate (DCR)
based on Investigator review of the images according to RECIST 1.1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Abnormalities in laboratory tests (haematology, blood biochemistry and urinalysis) [safety and tolerability]
Abnormalities in physical examination and performance status (ECOG) [safety and tolerability]
Abnormalities in blood pressure [safety and tolerability]
Abnormalities in heart rate [safety and tolerability]
Abnormalities in body temperature [safety and tolerability]
Abnormalities in respiration rate [safety and tolerability]
Abnormalities in body weight [safety and tolerability]
Abnormalities in 12-leads ECG parameters [safety and tolerability]

Full Information

First Posted
August 2, 2017
Last Updated
May 9, 2023
Sponsor
Institut de Recherches Internationales Servier
Collaborators
ADIR, a Servier Group company
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1. Study Identification

Unique Protocol Identification Number
NCT03274882
Brief Title
Study of Efficacy and Safety of S 95005 (TAS-102) in Patients With Metastatic Colorectal Cancer Who Failed Standard Chemotherapies
Official 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 Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 3, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Recherches Internationales Servier
Collaborators
ADIR, a Servier Group company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
metastatic, colorectal, cancer, Lonsurf, S95005, Russia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
S95005
Arm Type
Experimental
Arm Description
Film-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.
Intervention Type
Drug
Intervention Name(s)
S95005
Other Intervention Name(s)
TAS-102
Intervention Description
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).
Primary Outcome Measure Information:
Title
Progression free survival (PFS) rate
Description
percentage of patients alive without investigator-assessed radiological disease progression according to RECIST 1.1 after 2 months
Time Frame
at 2 months
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS).
Description
based on Investigator review of the images according to RECIST 1.1
Time Frame
Through study completion, an average of 12 weeks
Title
Overall Response Rate (ORR).
Description
based on Investigator review of the images according to RECIST 1.1
Time Frame
Through study completion, an average of 12 weeks
Title
Disease Control Rate (DCR)
Description
based on Investigator review of the images according to RECIST 1.1
Time Frame
Through study completion, an average of 12 weeks
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame
Through study completion, an average of 12 weeks
Title
Abnormalities in laboratory tests (haematology, blood biochemistry and urinalysis) [safety and tolerability]
Time Frame
Through study completion, an average of 12 weeks
Title
Abnormalities in physical examination and performance status (ECOG) [safety and tolerability]
Time Frame
Through study completion, an average of 12 weeks
Title
Abnormalities in blood pressure [safety and tolerability]
Time Frame
Through study completion, an average of 12 weeks
Title
Abnormalities in heart rate [safety and tolerability]
Time Frame
Through study completion, an average of 12 weeks
Title
Abnormalities in body temperature [safety and tolerability]
Time Frame
Through study completion, an average of 12 weeks
Title
Abnormalities in respiration rate [safety and tolerability]
Time Frame
Through study completion, an average of 12 weeks
Title
Abnormalities in body weight [safety and tolerability]
Time Frame
Through study completion, an average of 12 weeks
Title
Abnormalities in 12-leads ECG parameters [safety and tolerability]
Time Frame
Through study completion, an average of 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Pregnancy, breastfeeding Participation in another interventional study within 4 weeks prior to inclusion; participation in non-interventional registries or epidemiological studies is allowed 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 had certain other recent treatment e.g. major surgery, field radiation, anticancer therapy, within the specified time frames prior to inclusion Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 attributed to any prior therapies.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir MOISEENKO, Prof.
Organizational Affiliation
Saint Petersburg Clinical Scientific-Practical Center of Specialized Medical Care (Oncological)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Russian Cancer Research Center n.a. NN Blokhin (RCRC), Clinical Pharmacology and Chemotherapy department
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Saint Petersburg Clinical Scientific-Practical Center of Special Medical Care (Oncology Center)
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
After Marketing Authorisation in EEA or US if the study is used for the approval.
IPD Sharing 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.
IPD Sharing URL
http://clinicaltrials.servier.com
Links:
URL
https://clinicaltrials.servier.com/wp-content/uploads/CL2-95005-003-laysummary-2019.06.27-1.pdf
Description
Lay Summary
URL
https://clinicaltrials.servier.com/wp-content/uploads/CL2-95005-003-anonymised-synopsis.pdf
Description
Results Summary
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://clinicaltrials.servier.com/
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://clinicaltrials.servier.com/
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://clinicaltrials.servier.com/
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://clinicaltrials.servier.com/
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://clinicaltrials.servier.com/
Available IPD/Information Type
Study-level clinical trial data
Available IPD/Information URL
https://clinicaltrials.servier.com/

Learn more about this trial

Study of Efficacy and Safety of S 95005 (TAS-102) in Patients With Metastatic Colorectal Cancer Who Failed Standard Chemotherapies

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