A Phase 1 Study of the Oral TRK Inhibitor LOXO-101 in Adult Patients With Solid Tumors

Trial Profile

A Phase 1 Study of the Oral TRK Inhibitor LOXO-101 in Adult Patients With Solid Tumors

Recruiting
Phase of Trial: Phase I

Latest Information Update: 08 May 2018

At a glance

  • Drugs Larotrectinib (Primary)
  • Indications Small cell lung cancer; Solid tumours
  • Focus Adverse reactions; First in man
  • Sponsors Loxo Oncology
  • Most Recent Events

    • 08 May 2018 According to a Loxo Oncology media release, the FDA is expected to accept the filing of the New Drug Application in the first half of 2018, and a Marketing Authorisation Application submission by Bayer in the European Union is expected in 2018.
    • 26 Mar 2018 According to a Loxo Oncology media release, the company has completed the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring an NTRK gene fusion.
    • 22 Feb 2018 Results (n=55) of pooled analysis of NCT02122913, NCT02637687 and NCT02576431 trials assessing efficacy and safety published in the New England Journal of Medicine
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