Table 1. Study characteristics with matuzumab given as multiple 1 h i.v. infusions ranging from 400 to 2000 mg, q1w–q3w.
Study | Tumour entity | Dose regimen | Planned sampling timesa | No. of subjects |
---|---|---|---|---|
1 | Advanced pancreatic cancer | 400 mg q1w; 800 mg q2w; 800 mg q1w | Baseline, 1, 2, 5, 48, 96, 168, 672, 673, 674, 677, 720, 840b | 17 |
2 | Various advanced cancer (mainly colon/rectum cancer) | 1200 mg q1w, q2w, q3w; 400 mg q3w; 800 mg q3w; 1600 mg q3w | For q1w: baseline, 1, 2, 5, 48, 96, 168b; for q2w: baseline, 1, 2, 5, 48, 96, 168, 336b; for q3w: baseline, 1, 2, 5, 48, 168, 336, 504, 505, 506, 509, 552, 672, 840, 1008b | 51 |
3 | Various advanced cancer (mainly colon/rectum cancer) | 400 mg q1w; 800 mg q1w; 1200 mg q1w; 1600 mg q1w; 2000 mg q1w (from week2: 1600 mg) | Baseline, 1, 2, 5, 24, 72, 96, 168, 504, 505, 506, 509, 528, 576, 600, 672b | 22 |
Relative time elapsed after start of first infusion, in hours.
Before and after several other infusions peak and trough concentrations were analysed.