A Phase 3 interventional study of Trifluridine/Tipiracil hydrochloride (S95005) in Metastatic Colorectal Cancer, sponsored by Institut de Recherches Internationales Servier. Completed at 99 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-25.
Sponsored by Institut de Recherches Internationales Servier · Phase 3, Interventional, and Treatment
The purpose of this study is to collect additional safety and efficacy data during treatment with trifluridine / tipiracil in patients with a pretreated metastatic colorectal cancer (mCRC).
Eligible patients may receive an early access to trifluridine / tipiracil through this clinical study until progression of disease, unacceptable toxicity, investigator decision, patient refusal or until market authorization or reimbursement has been granted by the relevant Authority of the country where that patient is treated or until trifluridine / tipiracil is available by a doctor's prescription or can be accessed from another source or Sponsor decision.
Exclusion Criteria:
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, taken orally twice a day at the dose of 35 mg/m²/dose. The treatment is given until progression of disease, unacceptable toxicity, investigator decision, patient refusal or until market authorization or reimbursement has been granted by the relevant Authority of the country where that patient is treated or until trifluridine / tipiracil is available by a doctor's prescription or can be accessed from another source or Sponsor decision.
Drug: Trifluridine/Tipiracil hydrochloride (S95005)
Incidence of Adverse Events [safety and tolerability]
Time frame: Through 28 days following last administration of study medication
Abnormalities in laboratory assessment
Time frame: Through study completion, an average of 12 weeks
Abnormalities in performance status (ECOG)
Time frame: Through study completion, an average of 12 weeks
Abnormalities in vital signs
Time frame: Through study completion, an average of 12 weeks
Progression free survival (PFS)
time from the date of first study drug intake until the date of the investigator-assessed disease progression or death due to any cause whichever occurs first.
Time frame: Through study completion, an average of 12 weeks
Quality of life using the questionnaire EQ-5D
Time frame: Through study completion, an average of 12 weeks
Quality of life using the questionnaire EORTC QLQ-C30
Time frame: Through study completion, an average of 12 weeks
Plan to share: Yes — Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Institut de Recherches Internationales Servier