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A Randomized Phase 3 Study of Pemetrexed in Combination With Cisplatin Versus Cisplatin Monotherapy in Patients With Recurrent or Metastatic Head and Neck Cancer.

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Trial Profile

A Randomized Phase 3 Study of Pemetrexed in Combination With Cisplatin Versus Cisplatin Monotherapy in Patients With Recurrent or Metastatic Head and Neck Cancer.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Oct 2021

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At a glance

  • Drugs Pemetrexed (Primary) ; Cisplatin
  • Indications Head and neck cancer
  • Focus Biomarker; Therapeutic Use
  • Acronyms Spinnaker
  • Sponsors Eli Lilly and Company

    • Most Recent Events

    • 23 Jun 2012 Inclusion and exclusion criteria amended as reported by European Clinical Trials Database record.
    • 11 Oct 2010 As a result of the primary endpoint of the trial not being met, Lilly will not submit marketing authorization applications for pemetrexed in this indication with either the US FDA or the EMA in Europe, as reported in an Eli Lilly media release.
    • 11 Oct 2010 Primary endpoint 'Overall survival' has not been met, as reported in a media release from Eli Lilly.

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