A Study of Trifluridine/Tipiracil (Also Known as S 95005 or TAS-102) in Patients With a Pretreated Colorectal Cancer That Has Spread (Metastatic).

Study Overview
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Brief Summary
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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.

Official Title
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An Open-label Early Access Phase IIIb Study of Trifluridine / Tipiracil (S 95005/TAS-102) in Patients With a Pretreated Metastatic Colorectal Cancer (PRECONNECT)

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Drug: Trifluridine/Tipiracil hydrochloride (S95005)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female participant aged ≥18 years old. Has definitive histologically confirmed adenocarcinoma of the colon or rectum. Has metastatic lesion(s). Has received at least 2 prior regimens of standard chemotherapies (including fluoropyrimidines, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and at least one of the anti-EGFR monoclonal antibodies for RAS wild-type patients) for mCRC and is refractory or intolerant to those chemotherapies or is not candidate for those chemotherapies. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 during the screening period. Is able to take medications orally (i.e., no feeding tube). Has adequate organ function. Women of childbearing potential must have been tested negative in a serum pregnancy test within 7 days prior to first day of test drug administration. 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. Women and female partners using hormonal contraceptive must also use a barrier method. Exclusion Criteria: Pregnancy, breastfeeding or possibility of becoming pregnant during the study. Eligible for enrolment into another available ongoing clinical study of trifluridine / tipiracil. Has previously received trifluridine / tipiracil or hypersensitivity to the active substances or to any of the excipients of trifluridine / tipiracil. Has rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption. Has certain serious illness or medical condition(s) described in the protocol. Has had certain other recent treatment e.g. major surgery, anticancer therapy, radiation therapy, participation in another interventional study, within the specified time frames prior to first day of study drug administration. Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation, and platinum-induced neurotoxicity).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S95005<br>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)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events [safety and tolerability] |  | Through 28 days following last administration of study medication | 
| Abnormalities in laboratory assessment |  | Through study completion, an average of 12 weeks | 
| Abnormalities in performance status (ECOG) |  | Through study completion, an average of 12 weeks | 
| Abnormalities in vital signs |  | Through study completion, an average of 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through study completion, an average of 12 weeks | 
| Quality of life using the questionnaire EQ-5D |  | Through study completion, an average of 12 weeks | 
| Quality of life using the questionnaire EORTC QLQ-C30 |  | Through study completion, an average of 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic, colorectal, cancer, trifluridine/tipiracil, early access