A Phase I/Ib Dose Escalation Trial of Futibatinib in Combination With Paclitaxel/Ramucirumab in Second Line Confirmed Locally Advanced/Unresectable Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
Northwestern University
Summary
This phase I trial tests the safety, side effects and best dose of futibatinib with paclitaxel and ramucirumab for the treatment of patients with gastric, gastroesophageal junction or esophageal adenocarcinoma that has spread to nearby tissue or lymph nodes (locally advanced) or that cannot be removed by surgery (unresectable). Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving futibatinib with paclitaxel and ramucirumab may be safe and tolerable in treating patients with locally advanced or unresectable gastric, gastroesophageal junction or esophageal adenocarcinoma.
Description
PRIMARY OBJECTIVE: I. To determine the safety, tolerability and maximum tolerated dose (MTD) for futibatinib in combination with paclitaxel/ramucirumab in patients with confirmed locally advanced/unresectable gastric, gastroesophageal junction, or esophageal adenocarcinoma. SECONDARY OBJECTIVES: I. To determine the toxicity profile of futibatinib in combination with paclitaxel/ramucirumab in patients with confirmed locally advanced/unresectable gastric, gastroesophageal junction, or esophageal adenocarcinoma using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event…