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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

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

Latest Information Update: 22 Feb 2024

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At a glance

  • Drugs Entrectinib (Primary)
  • Indications Adenocarcinoma; Advanced breast cancer; Anaplastic large cell lymphoma; Brain metastases; Cholangiocarcinoma; CNS cancer; Colorectal cancer; Head and neck cancer; Malignant melanoma; Neuroendocrine tumours; Non-small cell lung cancer; Ovarian cancer; Pancreatic cancer; Renal cell carcinoma; Salivary gland cancer; Sarcoma; Solid tumours; Thyroid cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms STARTRK-2
  • Sponsors 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.
    • 30 Nov 2023 Planned number of patients changed from 700 to 510.
    • 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.
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