A phase I/II trial investigating the effect of entrectinib (RXDX-101) in solid tumours.

Trial Profile

A phase I/II trial investigating the effect of entrectinib (RXDX-101) in solid tumours.

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 06 Sep 2017

At a glance

  • Drugs Entrectinib (Primary)
  • Indications Solid tumours
  • Focus Adverse reactions; First in man; Registrational; Therapeutic Use
  • Sponsors Ignyta
  • Most Recent Events

    • 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. The company is on track to submit an NDA filing in the ROS1 NSCLC indication in the second half of 2018.
    • 09 Feb 2017 According to an Ignyta media release, results from two Phase I trials were published in the journal Cancer Discovery. (Data cutoff September 20, 2016 )
    • 09 Feb 2017 Results from two Phase I trials published in an Ignyta Media Release
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