Phase III Study of TAS-102 plus Best Supportive Care versus Placebo plus Best Supportive Care in Patients with Colorectal Cancer
What is the purpose of this trial?This is a clinical research trial of TAS-102 an investigational drug that has not yet received FDA approval. The purpose of this trial is to compare the effects, good and/or bad of TAS-102 and best supportive care with placebo (an inactive drug) and best supportive care on you and your refractory colorectal cancer to find out the effects on how long you may live, how much time may pass without disease progression and the safety. Placebo looks like TAS-102, but does not have any of the active components. It is not a medicine. In this study, you will get either the TAS-102 or the placebo. You will not get both. This is a double-blind trial, which means that neither you nor your study doctor will know what study drug you are receiving. If you choose to participate, you will be randomly assigned (like flipping a coin) to receive either TAS-102 or placebo (an inactive substance). You will have a two to one chance of receiving the TAS-102 study drug treatment You will be "randomized" into one of the study groups described below. Randomization means that you are put into a group by chance. A computer program will place you in one of the two study groups. Neither you nor your study doctor or nurses will know which group you are randomized to. You nor your study doctor or nurses can choose the group you will be in. You will receive TAS-102 or placebo twice a day for 5 days with 2 days rest for 2 weeks, repeated every 28 days, which is one cycle. Your assigned study drug (TAS-102 or Placebo) should be taken with a glass of water within 1 hour after finishing a meal (morning and evening meal). You may continue to receive the assigned study drug (TAS-102 or Placebo) for as long as your study doctor feels you are receiving benefit, until you meet a study discontinuation condition or until you choose to discontinue.
- 18 Years and older
- Taiho Pharma USA, Inc.
- December 2012
- Last Updated:
- Study HIC#:
Clinicaltrials.gov ID: Yale7008739