A Phase II Study of Entrectinib in Patients with Locally Advanced or Metastatic Solid Tumors Containing Gene Rearrangements in NTRK1/2/3, ROS1, or ALK

Full Title

An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors that Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements

Purpose

Entrectinib is an investigational drug that interferes with cancer growth in tumors containing mutations in the NTRK1, NTRK2, NTRK3, ROS1, or ALK genes. In this study, researchers are evaluating the safety and effectiveness of entrectinib in patients with locally advanced or metastatic solid tumors containing these gene rearrangements, including patients with non-small cell lung cancer and colorectal cancer. Entrectinib 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 locally advanced or metastatic non-small cell lung cancer, colorectal cancer, or another solid tumor that contains a mutation in the NTRK1, NTRK2, NTRK3, ROS1, or ALK genes.
  • Patients must recover from the serious side effects of prior therapies before entering the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Alexander Drilon at 646-888-4206.

Protocol

16-026

Phase

II

Investigator

Co-Investigators

Locations