What we are studying
You are being asked to join a clinical research trial because you have advanced gastric cancer for which no standard treatment exists.
The purpose of this trial is to compare the effects, good and/or bad of the following:
• TAS-102 and best supportive care
• Placebo (an inactive drug) and best supportive care
The trial will evaluate your advanced gastric cancer to find out the effects on how long you may live, how much time may pass without your gastric cancer getting worse, and safety.
In this trial, you will get either the TAS-102 or the Placebo. You will not get both. Placebo looks like TAS-102, but does not have any of the active components; it is not a drug. This is a double-blind trial, which means that neither you nor your trial doctor will know what trial drug (TAS-102 or Placebo) you are receiving.
You will continue to participate in the trial until one of the following occurs:
• Your cancer has gotten worse
• You decide to no longer participate
• Your trial doctor determines you should no longer receive the trial drug(s) due to side effects or for other reasons
• Sponsor or regulatory authority decides to stop the trial
• The trial has ended
• You become pregnant or inform your trial doctor that you intend to become pregnant
You will continue to be followed for survival via phone, every 4 weeks until the trial results are known, even after you discontinue taking the trial drug.
None at this time - may be negotiated within the CTA.