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  • ARRAY BEACON

    Acronym: 

    ARRAY BEACON

    ACTRN/NCT /ethics: 

    NCT02928224 Ethics: 41.17

    Scientific title: 

    A Multicenter, Randomized, Open-label, 3-Arm Phase 3 Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5- Fluorouracil (5-FU)/Folinic Acid (FA) /Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer

    Summary of trial and patient characteristics

    Cancer Type Bowel and colon
    Trial Type Treatment
    Phase Phase III Tumour Stream Colorectal Cancer
    Age Range 18 years and older Cancer Stage Metastatic or Widespread
    Sex Both Anticipated Start Date 2016-08-01
    Molecular Target Anticipated End Date 2019-07-01
    Cancer Type Bowel and colon
    Trial Type Treatment
    Phase Phase III
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Colorectal Cancer
    Cancer Stage Metastatic or Widespread
    Anticipated Start Date 2016-08-01
    Anticipated End Date 2019-07-01

    Trial Summary

    This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate encorafenib + cetuximab plus or minus binimetinib versus Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab, as controls, in patients with BRAFV600E mCRC whose disease has progressed after 1 or 2 prior regimens in the metastatic setting. The study contains a Safety Lead-in Phase in which the safety and tolerability of encorafenib + binimetinib + cetuximab will be assessed prior to the Phase 3 portion of the study.

    Lay Summary

    A Multicenter, Randomized, Open-label, 3-Arm Phase 3 Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5- Fluorouracil (5-FU)/Folinic Acid (FA) /Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer

    Sponsor / Cooperative group

    Array BioPharma

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Flinders Medical Centre Alex Scott-Hoy alex.scott-hoy@sa.gov.au 08 8204 4830 Chris Karapetis Recruiting