At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 800 enrolled
Drug / intervention
TAS-102 +1 moredrug
Likely dose
TAS-102 35 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double-blind, Phase 3 Study of TAS-102 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies
In Brief
A Phase 3 clinical trial evaluating TAS-102 and Placebo for Colorectal Cancer. Completed, enrolled 800 participants across 115 sites in 13 countries.
Detailed Summary
The purpose of this study is to compare the efficacy and safety of TAS-102 versus placebo in patients with refractory metastatic colorectal cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer
CountriesAustralia, Austria, Belgium, Czechia, France, Germany, Ireland, Italy, Japan, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 2012
Enrollment StartJun 2012
Primary CompletionJan 2014
Study CompletionMay 2016
TodayJul 2026
First PostedMay 30, 2012
Enrollment StartJun 17, 2012
Primary CompletionJan 31, 2014
Study CompletionMay 23, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 14.1 years ago
Interventions
TAS-102drug
35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met.
Placebodrug
Placebo tablets, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met.