Randomized Double-Blind, Phase III Study of TAS-102 plus Best Supportive Care (BSC) Versus Placebo Plus Best Supportive Care in Patients with Metastatic Colorectal Cancer Refractory to Standard Chemotherapies
What is the purpose of this trial?
This is multinational, double-blind, two-arm, parallel, randomized Phase 3 comparison study evaluating the efficacy and safety of TAS-102 vs. placebo in patientws with refractory metastatic colotrectal cancer. Patients will be randomly assigned (2:1) to TAS-102 (experimental arm) or placebo (control arm). Randomization will take place once the consented patient has completed all the necessary Baseline procedures and is deemed eligible for study entry. Treatment assignement will be done centrally using a dynamic allocation method (biased coin) via an Interactive Voice/Web Response System (IXRS) stratified by:
KRAS gene type (wild, mutant)
Time since diagnosis of first metastasis
Geographical region (Region 1:Asia/Japan, Region 2: Western/USA and Europe
- 18 Years and older
- Taiho Pharma USA, Inc.
- December 2012
- Last Updated:
- Study HIC#:
Clinicaltrials.gov ID: Yale7008739