A Phase II Study of LOXO-101 in Patients with Cancers Containing the NTRK Gene Fusion

Full Title

A Phase II Basket Study of the Oral TRK Inhibitor LOXO-101 in Subjects with NTRK Fusion-Positive Tumors (Version date 10-AUG-2016)


A genomic alteration called an NTRK fusion promotes the growth of some cancers. LOXO-101 is an investigational drug designed to slow tumor growth in cancers with NTRK fusions by inhibiting a family of proteins called TRK.

The purpose of this study is to assess the safety and effectiveness of LOXO-101 in patients with cancers that contain the NTRK fusion. LOXO-101 is taken orally (by mouth).


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

  • Patients must have an advanced cancer that contains an NTRK fusion and has continued to grow despite prior treatment. Examples include non-small cell lung cancer, thyroid cancer, sarcoma, colorectal cancer, salivary gland cancer, bile duct cancer, and brain tumors.
  • At least 2 weeks must pass between completion of prior anticancer therapy and entry into 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.