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An Open-label Phase 2 Study to Evaluate the Efficacy and Safety of Apalutamide in Combination With Gonadotropin-releasing Hormone (GnRH) Agonist in Subjects With Locally Advanced or Recurrent/Metastatic and Androgen Receptor (AR) Expressing Salivary Gland Carcinoma

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Trial Profile

An Open-label Phase 2 Study to Evaluate the Efficacy and Safety of Apalutamide in Combination With Gonadotropin-releasing Hormone (GnRH) Agonist in Subjects With Locally Advanced or Recurrent/Metastatic and Androgen Receptor (AR) Expressing Salivary Gland Carcinoma

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

Latest Information Update: 22 Oct 2024

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At a glance

  • Drugs Apalutamide (Primary) ; Goserelin (Primary)
  • Indications Carcinoma; Salivary gland cancer
  • Focus Therapeutic Use
  • Acronyms YATAGARASU
  • Sponsors Janssen Pharmaceutical KK

    • Most Recent Events

    • 18 Oct 2024 Planned End Date changed from 30 Sep 2025 to 31 Dec 2027.
    • 26 Mar 2024 Planned End Date changed from 31 May 2024 to 30 Sep 2025.
    • 24 Oct 2023 According to a TerSera Therapeutics media release, based on data from NCT04325828,NCT03942653 and a retrospective study, the National Comprehensive Cancer Network (NCCN) Head and Neck Cancers Panel included a category 2B recommendation for goserelin as useful, in certain circumstances, for recurrent, unresectable, or metastatic salivary gland tumors (with no surgery or radiation therapy option) in Version 1.2024 of the Head and Neck Cancers Guidelines released on October 9, 2023.

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