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Trial record 1 of 1 for:    CL2-95005-003
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Study of Efficacy and Safety of S 95005 (TAS-102) in Patients With Metastatic Colorectal Cancer Who Failed Standard Chemotherapies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03274882
Recruitment Status : Completed
First Posted : September 7, 2017
Last Update Posted : December 3, 2019
Sponsor:
Collaborator:
ADIR, a Servier Group company
Information provided by (Responsible Party):
Servier ( Institut de Recherches Internationales Servier )

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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: S95005 Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 3, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 3, 2018

Arm Intervention/treatment
Experimental: S95005
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.
Drug: S95005
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).
Other Name: TAS-102




Primary Outcome Measures :
  1. Progression free survival (PFS) rate [ Time Frame: 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. Progression-Free Survival (PFS). [ Time Frame: Through study completion, an average of 12 weeks ]
    based on Investigator review of the images according to RECIST 1.1

  2. Overall Response Rate (ORR). [ Time Frame: Through study completion, an average of 12 weeks ]
    based on Investigator review of the images according to RECIST 1.1

  3. Disease Control Rate (DCR) [ Time Frame: Through study completion, an average of 12 weeks ]
    based on Investigator review of the images according to RECIST 1.1

  4. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Through study completion, an average of 12 weeks ]
  5. Abnormalities in laboratory tests (haematology, blood biochemistry and urinalysis) [safety and tolerability] [ Time Frame: Through study completion, an average of 12 weeks ]
  6. Abnormalities in physical examination and performance status (ECOG) [safety and tolerability] [ Time Frame: Through study completion, an average of 12 weeks ]
  7. Abnormalities in blood pressure [safety and tolerability] [ Time Frame: Through study completion, an average of 12 weeks ]
  8. Abnormalities in heart rate [safety and tolerability] [ Time Frame: Through study completion, an average of 12 weeks ]
  9. Abnormalities in body temperature [safety and tolerability] [ Time Frame: Through study completion, an average of 12 weeks ]
  10. Abnormalities in respiration rate [safety and tolerability] [ Time Frame: Through study completion, an average of 12 weeks ]
  11. Abnormalities in body weight [safety and tolerability] [ Time Frame: Through study completion, an average of 12 weeks ]
  12. Abnormalities in 12-leads ECG parameters [safety and tolerability] [ Time Frame: Through study completion, an average of 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03274882


Locations
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Russian Federation
Russian Cancer Research Center n.a. NN Blokhin (RCRC), Clinical Pharmacology and Chemotherapy department
Moscow, Russian Federation, 115478
Saint Petersburg Clinical Scientific-Practical Center of Special Medical Care (Oncology Center)
Saint Petersburg, Russian Federation, 197758
Sponsors and Collaborators
Institut de Recherches Internationales Servier
ADIR, a Servier Group company
Investigators
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Principal Investigator: Vladimir MOISEENKO, Prof. Saint Petersburg Clinical Scientific-Practical Center of Specialized Medical Care (Oncological)
Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site

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Responsible Party: Institut de Recherches Internationales Servier
ClinicalTrials.gov Identifier: NCT03274882    
Other Study ID Numbers: CL2-95005-003
ISRCTN14228310 ( Registry Identifier: ISRCTN )
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
URL: http://clinicaltrials.servier.com

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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
Keywords provided by Servier ( Institut de Recherches Internationales Servier ):
metastatic
colorectal
cancer
Lonsurf
S95005
Russia
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases