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A Phase 1, Multicenter, Open-Label Study of Oral Entrectinib (RXDX-101) in Adult Patients With Locally Advanced or Metastatic Cancer Confirmed to be Positive for NTRK1, NTRK2, NTRK3, ROS1, or ALK Molecular Alterations

Trial Profile

A Phase 1, Multicenter, Open-Label Study of Oral Entrectinib (RXDX-101) in Adult Patients With Locally Advanced or Metastatic Cancer Confirmed to be Positive for NTRK1, NTRK2, NTRK3, ROS1, or ALK Molecular Alterations

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 30 Oct 2019

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At a glance

  • Drugs Entrectinib (Primary)
  • Indications Solid tumours
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms STARTRK-1
  • Sponsors Ignyta; Roche
  • Most Recent Events

    • 30 Oct 2019 Results comparing effectiveness of Larotrectinib vs. Entrectinib in patients with non-small cell lung cancer from studies (NCT02122913, NAVIGATE, ALKA-372-001, STARTRK-1, and STARTRK-2), presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 2019.
    • 10 Sep 2019 Results (as of 31 May 2018) assessing NTRK fusion-positive solid tumors (NTRK+) or ROS1 fusion-positive NSCLC (ROS1+) from three phase 1/2 studies (ALKA-372-001, STARTRK-1 and STARTRK-2), presented at the 20th World Conference on Lung Cancer.
    • 15 Aug 2019 According to a Genentech media release, the FDA has also granted accelerated approval to Rozlytrek for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.
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