A Phase III Study of TAS-102 or Placebo with Best Supportive Care to Treat Persistent Metastatic Stomach Cancer

Full Title

Randomized, Double-Blind, Phase 3 Study Evaluating TAS-102 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Patients with Metastatic Gastric Cancer Refractory to Standard Treatments

Purpose

TAS-102 is an anticancer drug that prevents cancer cells from multiplying. It is approved for the treatment of metastatic colorectal cancer. In this study, researchers want to see if giving TAS-102 with best supportive care is more effective than best supportive care alone in patients with metastatic gastric (stomach) cancer that has continued to grow despite other treatments.

Patients will be randomly assigned to receive best supportive care with TAS-102 or with a placebo (sugar pill). TAS-102 is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic adenocarcinoma of the stomach or gastroesophageal junction that continues to grow despite at least two prior regimens of chemotherapy.
  • Patients must recover from the serious side effects of prior treatments before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Geoffrey Ku at 646-888-4588.

Protocol

16-771

Phase

III

Investigator

Co-Investigators