NCT02576431


Study of LOXO-101 in Subjects with NTRK Fusion Positive Solid Tumors



Adult


This is a Phase II, multi-center, open-label study of patients with advanced solid tumors harboring a fusion of NTRK1, NTRK2 or NTRK3. Patients with NTRK1, NTRK2 or NTRK3 fusion-positive cancers will be identified through molecular assay.

LOXO-101 will be administered at 100mg twice daily (BID), with each cycle consisting of 28 days of dosing administered on a continuous basis.

The study will include 8 cohorts of patients with tumors bearing NTRK fusions, including non small cell lung cancer, thyroid cancer, sarcoma, colorectal cancer, salivary gland cancer, biliary cancer and primary CNS tumor, as well as a cohort that will enroll patients not included in the histologies listed above.


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