A Randomized, Multicenter, Open-label, Phase 3 Study to Compare the Efficacy and Safety of Panitumumab and Cetuximab in Subjects with Previously Treated, Wild-type KRAS, Metastatic Colorectal Cancer

Trial Profile

A Randomized, Multicenter, Open-label, Phase 3 Study to Compare the Efficacy and Safety of Panitumumab and Cetuximab in Subjects with Previously Treated, Wild-type KRAS, Metastatic Colorectal Cancer

Completed
Phase of Trial: Phase III

Latest Information Update: 26 Oct 2017

At a glance

  • Drugs Panitumumab (Primary) ; Cetuximab
  • Indications Colorectal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ASPECCT
  • Sponsors Amgen
  • Most Recent Events

    • 26 Oct 2017 Results of analysis exploring the mutations in EGFR pathway genes and their association with outcomes presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 2017
    • 29 Jun 2017 Results published in an Amgen media release.
    • 29 Jun 2017 According to an Amgen media release, the FDA has approved Vectibix (panitumumab) for the treatment of wild-type RAS metastatic colorectal cancer. The full approval for Vectibix as a treatment for patients with wild-type KRAS mCRC was based on results from the Phase 3 PRIME and ASPECCT trials. The approval of a refined indication for the treatment of patients with wild-type RAS mCRC was based on a retrospective analysis from this study and prospective, pre-defined analyses from the 0007 study.
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