Study to compare the outcome for people with stomach cancer treated with the standard of care medication plus an experimental drug or with a placebo.

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 between TAS-102 and best supportive care and 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, or 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.

Who is Eligible

  • Genders:
    • Men
    • Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Able to take medications orally
  • Have adequate organ function
  • Willing and able to comply with scheduled visits/treatment plans/laboratory tests/study procedures
  • Women of childbearing potential must have a negative pregnancy test
  • No myocardial infarction events within 12 months prior to study start
  • Can not have previously received TAS-102

What is involved

  • Physical Examination
  • Vital Signs & Weight
  • ECOG Performance Status
  • Pregnancy Test
  • Blood and urine lab tests
  • CT scans and Tumor Measurements
  • Quality of Life Questionnaires

Compensation

None at this time - may be negotiated within the CTA.

Contact Information

Study Coordinator
Amy W. Neal
Email
[email protected]
Phone
-6912
Principal Investigator
Rodwige J. Desnoyers, MD

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.