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A Phase II Randomised Controlled Trial to Determine the Efficacy of Combining the HDAC Inhibitor Sodium Valproate With EGFR Monoclonal Antibody (Panitumumab or Cetuximab) Maintenance in the First-line Treatment of Patients With RAS Wild Type Metastatic Colorectal Cancer (CRC)
Australasian Gastro-Intestinal Trials Group (AGITG)
Other Non-Commercial Sponsor
Olivia Newton-John Cancer Research Institute
Eligible participants will be randomly allocated to either the Experimental or Active Comparator Arm. In the Experimental Arm, participants will receive either panitumumab (6mg/kg intravenously every 2 weeks) or cetuximab (500mg/m2 intravenously every 2 weeks), plus sodium valproate, orally, in a twice daily dose (target daily dose of 20mg/kg/d at Cycle 1 Day 13, then dose adjusted to maintain serum VPA levels within the target range of 50-100 μg/mL). In the Active Comparator Arm, participants will receive either panitumumab (6mg/kg intravenously every 2 weeks) or cetuximab 500mg/m2 intravenously every 2 weeks).