A Phase 2 interventional study of Trifluridine/Tipiracil in Cholangiocarcinoma and Bile Duct Cancer, sponsored by Sunnybrook Health Sciences Centre. Terminated at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-01.
Sponsored by Sunnybrook Health Sciences Centre · Phase 2, Interventional, and Treatment
This is a multi-centre, open-label, single arm phase 2 study to assess the efficacy of TRIFLURIDINE/TIPIRACIL, in patients with advanced cholangiocarcinoma as measured by median progression-free survival (PFS).
This study will enroll a total of 47 patients over a 12-month period, according to a two stage enrollment design. Nine patients will be enrolled during the first stage and the trial will be terminated if 4 or more out of the 9 have disease progression. If the trial goes on to the second stage, a total of 47 patients (38 in second stage) will be required.
Patients will be seen prior to enrolment (within 28 days of treatment), every 4 weeks while on treatment, at the end of treatment, and 30 days post-treatment. Patients will remain on long-term follow-up and will be seen every 12 weeks (+/- 14 days) until 1 year post-treatment when they will enter into the survival follow-up period and will be contacted every 12 weeks by phone until progression or toxicity.
914 studies on the registry are indexed under Cholangiocarcinoma; 286 are open to participants now.
This study's enrollment of 8 is below the median of 50 across 687 interventional studies indexed under Cholangiocarcinoma.
Browse Cholangiocarcinoma studies →Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adequate hematologic function defined by the following laboratory parameter:
Adequate hepatic and renal function as defined by:
Exclusion Criteria:
FTD/TPI at 35 mg/m2 (based on BSA) that is administered in tablet form, orally, twice daily, within one hour of morning and evening meals, on days 1-5 and days 8-12 of a 28 day cycle.
Drug: Trifluridine/Tipiracil
FTD/TPI is an orally administered combination of a thymidine-based nucleic acid analogue, trifluridine, and a thymidine phosphorylase inhibitor, tipiracil hydrochloride. Trifluridine is the active cytotoxic component of FTD/TPI; its triphosphate form is incorporated into DNA, with such incorporation appearing to result in its anti- tumor effects. Tipiracil hydrochloride is a potent inhibitor of thymidine phosphorylase and, when combined with trifluridine to form FTD/TPI, prevents the rapid degradation of the trifluridine, allowing for the maintenance of adequate plasma levels of the active drug.
Also known as: FTD/TPI, Lonsurf
Median progression-free survival (PFS)
As measured on the basis of RECIST v1.1 criteria
Time frame: From enrolment until the date of objective radiological disease progression according to RECIST v1.1 or death (by any cause in the absence of progression) up to 1 year
Safety and tolerability of FTD/TPI: CTCAE version 5.0
Assessed by using CTCAE version 5.0 and tolerability
Time frame: Day 1 of each new treatment cycle (each cycle is 28 days), and at the end of treatment visit (up to 1 year after enrolment)
Disease Control Rate (Complete Response, Partial Response, Stable Disease) of FTD/TPI
As measured on the basis of RECIST v1.1 criteria
Time frame: From enrolment until the date of objective radiological disease progression according to RECIST v1.1 or death (by any cause in the absence of progression) up to 1 year
Duration of response of FTD/TPI
As measured on the basis of RECIST v1.1 criteria
Time frame: From enrolment until the date of objective radiological disease progression according to RECIST v1.1 or death (by any cause in the absence of progression) up to 1 year
Median overall survival of patients with cholangiocarcinoma treated with FTD/TPI.
As measured on the basis of RECIST v1.1 criteria
Time frame: From enrolment until the date of objective radiological disease progression according to RECIST v1.1 or death (by any cause in the absence of progression) up to 1 year
Quality of life: European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30
As measured by the European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ C30) Functioning, symptoms, and global health status scores will be calculated, graphed, and summarized at baseline and each follow-up visit. General linear mixed model will be conducted to detect significant changing over time for functioning, symptoms and global health status scores. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems
Time frame: Baseline, and Day 1 of each new treatment cycle (each cycle is 28 days), and at the end of treatment visit (up to 1 year after enrolment)
This study is terminated, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Sunnybrook Health Sciences Centre