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A Phase 1 Study to Assess Safety, Pharmacokinetics, and Pharmacodynamics of PLX3397 in Patients With Advanced, Incurable, Solid Tumors in Which the Target Kinases Are Linked to Disease Pathophysiology

Trial Profile

A Phase 1 Study to Assess Safety, Pharmacokinetics, and Pharmacodynamics of PLX3397 in Patients With Advanced, Incurable, Solid Tumors in Which the Target Kinases Are Linked to Disease Pathophysiology

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 20 Feb 2024

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At a glance

  • Drugs Pexidartinib (Primary)
  • Indications Carcinoma; Gastrointestinal stromal tumours; Giant cell tumour of tendon sheath; Pigmented villonodular synovitis; Salivary gland cancer; Solid tumours; Thyroid cancer
  • Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
  • Sponsors Daiichi Sankyo Company
  • Most Recent Events

    • 29 Oct 2021 Interim results (data cut off: January 31, 2018; n=91) assessing the response to pexidartinib treatment in 6 cohorts of adult patients with advanced, incurable solid tumors associated with colony-stimulating factor 1 receptor (CSF1R) and/or KIT proto-oncogene receptor tyrosine kinase activity published in the Clinical Cancer Research
    • 11 Mar 2021 Status changed from active, no longer recruiting to completed.
    • 16 Nov 2020 Results of pooled analysis of data from 2 studies (NCT01004861 and NCT02371369) assessing the long term outcomes of Pexidartinib in tenosynovial giant cell tumors published in the Cancer
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