A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer

Studien-Informationen

Ein-/Ausschlusskriterien

Studien-Rationale

Studien-Arme

• Experimental: Tucatinib Arm
  Tucatinib + trastuzumab + mFOLFOX6
• Active Comparator: Standard of Care Arm
  mFOLFOX6 + (bevacizumab OR cetuximab). Either (1) mFOLFOX6, (2) mFOLFOX6 and bevacizumab, or (3) mFOLFOX6 and cetuximab

Geprüfte Regime

• tucatinib (TUKYSA, ONT-380, ARRY-380, PF-07265792):
  300mg given by mouth (orally) twice daily
• trastuzumab (Herceptin):
  8mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 day 1, followed by 6mg/kg given by IV every 3 weeks thereafter.
• bevacizumab (Avastin):
  5mg/kg given by IV every 2 weeks
• cetuximab (Erbitux):
  400mg/m2 loading dose will be given by IV on Cycle 1 day 1, followed by 250mg/m2 given by IV weekly
• oxaliplatin:
  85mg/m2 given by IV every 2 weeks. Component of mFOLFOX6.
• leucovorin:
  400mg/ m2 given by IV every 2 weeks. Component of mFOLFOX6.
• levoleucovorin:
  200mg/ m2 given by IV every 2 weeks. May be given in place of leucovorin. Component of mFOLFOX6.
• fluorouracil:
  400mg/m2 given by IV bolus then 2400mg/m2 given by continuous IV infusion (over 46-48 hours) every 2 weeks. Component of mFOLFOX6.

Quelle: ClinicalTrials.gov