A phase I study of TSU-68 in patient with metastatic colorectal cancer

Intervention name : TSU-68, S-1, Oxaliplatin
INN of the intervention : TSU-68:orantinib, S-1: tegafur, gimeracil, oteracil potassium oxaliplatin
Dosage And administration of the intervention : Treatment is repeated every 21 days as follows: S-1 is orally administered at 35 mg/m2 twice a day after meals on day 1-14 followed by 7 days rest. Oxaliplatin is given as an intravenous infusion of 130 mg/m2 on day 1. TSU-68 is orally administered at 200 mg or 400 mg twice a day after meals on day 1 to 21.
Control intervention name : null
Primary outcome(s): Safety (dose limiting toxicity)
CTCAE (ver. 3.0)
Study Design: Open-label, phase I study