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A phase 1b, safety, PK, and efficacy, multicenter, dose-escalating study of imprime PGG in combination with cetuximab/irinotecan therapy in patients with and without recurrent/progressive colorectal carcinoma following treatment with a 5-FU regimen

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A phase 1b, safety, PK, and efficacy, multicenter, dose-escalating study of imprime PGG in combination with cetuximab/irinotecan therapy in patients with and without recurrent/progressive colorectal carcinoma following treatment with a 5-FU regimen

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 10 Nov 2021

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At a glance

  • Drugs Odetiglucan (Primary) ; Cetuximab; Irinotecan
  • Indications Carcinoma; Colorectal cancer
  • Focus Adverse reactions; Proof of concept
  • Sponsors Biothera

    • Most Recent Events

    • 13 Oct 2010 Final results have been presented at the 35th European Society for Medical Oncology (ESMO) Congress, according to a Biothera media release. Results from both study arms, plus a retrospective analysis, were also reported in the media release.
    • 07 Jul 2010 Results presented at the World Congress on Gastrointestinal Cancer at the European Society for Medical Oncology and also in media release from Biothera.
    • 02 Apr 2010 Actual end date (Dec 2009) added as reported by ClinicalTrials.gov.

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