At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 406 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 III Study of TAS-102 Versus Placebo in Asian Patients With Metastatic Colorectal Cancer Refractory or Intolerable to Standard Chemotherapies
In Brief
A Phase 3 clinical trial evaluating TAS-102 and Placebo for Colorectal Cancer. Completed, enrolled 406 participants across 4 sites in 3 countries.
Detailed Summary
To compare the effects of TAS-102 with placebo in patients with metastatic colorectal cancer refractory or intolerable to standard chemotherapies.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer
CountriesChina, South Korea, Thailand
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartSep 2013
First PostedOct 2013
Primary CompletionFeb 2016
Study CompletionJun 2016
TodayJul 2026
First PostedOct 8, 2013
Enrollment StartSep 1, 2013
Primary CompletionFeb 16, 2016
Study CompletionJun 30, 2016
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 12.7 years ago
Interventions
TAS-102drug
TAS-102 (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 is met.
Placebodrug
Placebo 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 is met.