A Randomized, Multicenter, Phase 3 Study to Compare the Efficacy of Panitumumab in Combination With Oxaliplatin/ 5-Fluorouracil/ Leucovorin to the Efficacy of Oxaliplatin/ 5-Fluorouracil/ Leucovorin Alone in Patients With Previously Untreated Metastatic Colorectal Cancer.

Trial Profile

A Randomized, Multicenter, Phase 3 Study to Compare the Efficacy of Panitumumab in Combination With Oxaliplatin/ 5-Fluorouracil/ Leucovorin to the Efficacy of Oxaliplatin/ 5-Fluorouracil/ Leucovorin Alone in Patients With Previously Untreated Metastatic Colorectal Cancer.

Completed
Phase of Trial: Phase III

Latest Information Update: 12 Sep 2017

At a glance

  • Drugs Panitumumab (Primary) ; Fluorouracil; Folinic acid; Oxaliplatin
  • Indications Colorectal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms PRIME
  • Sponsors Amgen
  • Most Recent Events

    • 12 Sep 2017 Results (n=154) of retrospective analysis using data from PRIME and PEAK trials assessing outcomes in patients receiving maintainence therapy , presented at the 42nd European Society for Medical Oncology Congress.
    • 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.
    • 29 Jun 2017 Results published in an Amgen media release.
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