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

Trial Profile

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

Recruiting
Phase of Trial: Phase II

Latest Information Update: 14 Oct 2017

At a glance

  • Drugs Entrectinib (Primary)
  • Indications Anaplastic large cell lymphoma; Gastrointestinal cancer; Non-small cell lung cancer; Solid tumours
  • Focus Registrational; Therapeutic Use
  • Acronyms STARTRK-2
  • Sponsors Ignyta
  • Most Recent Events

    • 11 Sep 2017 According to an Ignyta media release, data from this study will be presented at the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer (WCLC).
    • 06 Sep 2017 According to an Ignyta media release, the company is on track to submit an NDA filing in the ROS1 NSCLC indication in the second half of 2018.
    • 06 Sep 2017 According to an Ignyta media release, the U.S. Food and Drug Administration's (FDA) most recent guidance confirmed that the NDA submission for ROS1-positive NSCLC will be based on three single arm studies, including two Phase 1 studies, ALKA and STARTRK-1, and the Phase 2 STARTRK-2 basket trial; no additional studies were requested by FDA.
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