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A Phase 3, Multicenter, Randomized, Open-label Trial to Evaluate the Survival Benefit of Panitumumab and Best Supportive Care, Compared to Best Supportive Care Alone, in Subjects With Chemorefractory Wild-type KRAS Metastatic Colorectal Cancer

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Trial Profile

A Phase 3, Multicenter, Randomized, Open-label Trial to Evaluate the Survival Benefit of Panitumumab and Best Supportive Care, Compared to Best Supportive Care Alone, in Subjects With Chemorefractory Wild-type KRAS Metastatic Colorectal Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Panitumumab (Primary)
  • Indications Colorectal cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Amgen

    • Most Recent Events

    • 25 Jan 2020 Results (n=210) assessing tumor heterogeneity via ctDNA analysis in phase 3 studies by comparing (first line treatment (1L; study 20050203; panitumumab + fluorouracil, leucovorin and oxaliplatin [FOLFOX4] vs FOLFOX4) with third line treatment (3L; study 20100007; panitumumab + best supportive care [BSC] vs BSC)] in metastatic colorectal cancer patients, presented at the 2020 Gastrointestinal Cancers Symposium.
    • 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 the PRIME study and prospective, pre-defined analyses from this trial.
    • 29 Jun 2017 Results published in an Amgen media release.
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