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Phase Ib/II trial of copanlisib, a selective PI3K inhibitor, in combination with cetuximab in patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) harboring a PI3KCA mutation/amplification and/or a PTEN loss

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Trial Profile

Phase Ib/II trial of copanlisib, a selective PI3K inhibitor, in combination with cetuximab in patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) harboring a PI3KCA mutation/amplification and/or a PTEN loss

Status: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Cetuximab (Primary) ; Copanlisib (Primary)
  • Indications Head and neck cancer; Hypopharyngeal cancer; Laryngeal cancer; Mouth neoplasm; Oropharyngeal cancer; Squamous cell cancer
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms Copan-H&N; COPAN-ORL06

    • Most Recent Events

    • 28 Jul 2021 Results assessing efficacy, safety and pharmacokinetics of copanlisib in combination with cetuximab in patients with recurrent and/or metastatic head and neck squamous cell carcinoma who failed platinum and cetuximab therapy, published in the Investigational New Drugs.
    • 24 Mar 2021 Status changed from completed to discontinued.
    • 05 Dec 2019 Status changed from dicontinued to completed.
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