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


ABSTRACT: Interventions: investigational material(s) Generic name etc : TSU-68, S-1, Oxaliplatin INN of investigational material : TSU-68:orantinib, S-1: tegafur, gimeracil, oteracil potassium, oxaliplatin Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 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. Additionally for the patients of group A, TSU-68 is orally administered at 200 mg twice a day after meals on day 1 to 21. control material(s) Generic name etc : S-1, Oxaliplatin INN of investigational material : S-1: tegafur, gimeracil, oteracil potassium oxaliplatin Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 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. Primary outcome(s): Progression free survival RECIST (ver. 1.1) Study Design: Open-label, multicenter, randomized phase II study

DISEASE(S): Metastatic Colorectal Cancer

PROVIDER: 100336 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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