A Phase II Study of Nintedanib in Patients with Advanced Esophagogastric Cancer

Full Title

Phase II Trial of Nintedanib in Patients with Advanced Esophagogastric Cancer

Purpose

There are several established chemotherapy regimens used in the initial treatment of advanced cancer of the esophagus, stomach, or the junction of the stomach and esophagus (gastroesophageal junction, or GEJ). However, there is no standard therapy to use when the cancer comes back.

In this study, researchers are assessing the safety and effectiveness of the investigational drug nintedanib in patients with advanced cancer of the esophagus, stomach, or GEJ that has returned after prior treatment. Nintedanib inhibits the development of the blood vessels that tumors need to grow and spread. It blocks the activity of three enzymes needed for this process. Nintedanib 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 esophageal, stomach, or GEJ cancer that has returned after one prior regimen of therapy for advanced disease.
  • Patients may not have cancers that are positive for the HER2 protein. (There are other therapies available that target this protein.)
  • Patients may not have previously received treatment with an inhibitor of VEGFR (one of the targets of nintedanib).
  • This study is for patients age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Yelena Janjigian at 646-888-4186.

Protocol

14-094

Phase

II

Investigator

Co-Investigators