Full TitleA 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.