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  • A randomised, open-label, Phase II, dose/schedule optimisation study of NUC-3373/leucovorin/irinotecan plus bevacizumab (NUFIRI-bev) versus 5-FU/leucovorin/irinotecan plus bevacizumab (FOLFIRI-bev) for the treatment of patients with previously treated unresectable metastatic colorectal cancer

    Cancer Categories
    • Gastrointestinal (GI)
    Karmanos Trial ID
    • 2022-126
    NCT ID
    • NCT05678257
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase II
    Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
    • Phase II
    Principal Investigator
    • Mohammed Najeeb
      Al Hallak, M.D., MS

      Oncology - Medical View Profile

    Objective:

    Primary Objectives:

    • To compare PFS of NUC-3373 in combination with LV, irinotecan and bevacizumab (NUFIRI-bev) with 5-FU in combination with LV, irinotecan and bevacizumab (FOLFIRI-bev)
    • To determine the optimal NUFIRI-bev dosing schedule

    Secondary Objectives:

    • To compare the efficacy of NUFIRI-bev to FOLFIRI-bev in terms of:
      • Objective response rate (ORR)
      • Duration of response (DoR)
      • Disease control rate (DCR)
      • Maximum percentage change in tumour size
      • Overall survival (OS)
    • To assess the safety and tolerability of NUFIRI-bev compared to FOLFIRI-bev
    • To assess the PK of NUFIRI-bev
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
    Get Directions
    Phone: 800-527-6266

    Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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    Phone: 800-527-6266