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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
907
Chris O'Brien Lifehouse Oncology
Camperdown, Australia
St Vincent's Hospital The Kinghorn Cancer Centre
Darlinghurst, Australia
St Vincent's Hospital (Melbourne) Cancer Centre
Fitzroy, Australia
The Canberra Hospital Cancer,Ambulatory & Community Health Service (CACHS) Bldg 19
Garran, Australia
Royal Brisbane & Women's Hospital Clinical Research Unit
Herston, Australia
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
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