A-TANGO Phase 2 Study

"Matching placebo for TAK-242: 5% dextrose solution and commercially available 20% intralipid (prepared by hospital pharmacy staff)~Matching placebo for G-CSF: identical to vehicle for filgrastim (prepared for injection by hospital pharmacy staff)"

"TAK-242 concentrate for solution for infusion (80 mg/ mL in 3 mL ethanol) ): 240 mg TAK-242 per vial. To be reconstituted with 5% dextrose (36 mL) and commercially available 20% intralipid (21 mL).~TAK-242) will be administered as a continuous IV infusion starting with a loading dose of 0.9 mg/kg administered over 30 minutes, followed by a continuous, constant rate infusion of 1.8 mg/kg/day for 10 days.~PLUS placebo for G- CSF"

"Commercially available vials for subcutaneous injection. Quantitative composition (per mL):~Filgrastim: 300 mcg Acetate: 0.59 mg Sorbitol: 50.0 mg Tween® 80: 0.04 mg Sodium: 0.035 mg Water for Injection USP q.s. ad 1.0 mL~G-CSF will be given subcutaneously once daily at a dose of 5 µg/kg for 5 days (Day 1-5) and at Day 8 (6 injections in total)"