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A Phase I/II Randomized Study to Determine the Maximum Tolerated Dose, Safety, Pharmacokinetics and Antitumor Activity of Debio 1143 Combined With Concurrent Chemo-Radiation Therapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Trial Profile

A Phase I/II Randomized Study to Determine the Maximum Tolerated Dose, Safety, Pharmacokinetics and Antitumor Activity of Debio 1143 Combined With Concurrent Chemo-Radiation Therapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 03 Oct 2023

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At a glance

  • Drugs Xevinapant (Primary) ; Cisplatin
  • Indications Head and neck cancer; Hypopharyngeal cancer; Laryngeal cancer; Mouth neoplasm; Oropharyngeal cancer; Squamous cell cancer
  • Focus Proof of concept; Therapeutic Use
  • Acronyms GORTEC
  • Sponsors Debiopharm
  • Most Recent Events

    • 30 Sep 2023 Results published in the Clinical Pharmacology and Therapeutics
    • 09 Jan 2023 Results assessing long-term efficacy and overall survival of xevinapant plus chemoradiotherapy in high-risk locally advanced squamous cell carcinoma of the head and neck published in the European Journal of Cancer
    • 13 Sep 2022 Updated results (n=96, until April 2022 )assessing duration of response after 3 years and OS after 5 years in patients with locally advanced squamous cell carcinoma of the head and neck presented at the 47th European Society for Medical Oncology Congress
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