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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

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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: Completed
Phase of Trial: Phase I

Latest Information Update: 06 Jan 2025

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At a glance

  • Drugs Entrectinib (Primary) ; Entrectinib (Primary)
  • Indications Adenocarcinoma; Brain metastases; Non-small cell lung cancer; Solid tumours
  • Focus Adverse reactions; First in man; Registrational; Therapeutic Use
  • Acronyms STARTRK-1
  • Sponsors Ignyta; Roche

Most Recent Events

  • 01 Feb 2024 Results of updated data cohort of patients with NTRK fusion-positive (fp) NSCLC (objective response rate [ORR]: 64.5 %; 2 August 2021 data cut-off) from three phase I/II studies (ALKA-372-001: EudraCT 2012-000148-88; STARTRK-1: NCT02097810; STARTRK-2: NCT02568267) assessing efficacy in patients with NTRK fusion-positive (fp) NSCLC published in the Lung Cancer.
  • 12 Sep 2023 Results assessing Individual patient data (IPD) from entrectinib trials (ALKA-372-001/EudraCT 2012-000148-88, STARTRK-1/NCT02097810 and STARTRK-2/NCT02568267) and aggregate data from a crizotinib trial (OxOnc/NCT01945021) using unanchored matching adjusted indirect comparison, presented at the 24th World Conference on Lung Cancer.
  • 06 Jun 2023 Results of updated data from EudraCT, 201200014888, NCT02097810, NCT02568267 presented at the 59th Annual Meeting of the American Society of Clinical Oncology

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