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• W2024257726 abstract "A single-agent dose-escalating phase I and pharmacokinetic study on TSU-68, a novel multiple receptor tyrosine kinase inhibitor, was performed to determine the safety profile, maximum-tolerated dose for Japanese patients with advanced solid tumors and to define the recommended dose of phase II studies. Study design was a dose escalation method on a three-patient cohort. TSU-68 was given orally twice daily (bid) between meals without interruption; the estimation of dose escalation was based on the toxicity within 4 week administration at each dose level. Fifteen patients were enrolled into the study. Dose levels studied were 200, 400, 800, and 1,200 mg/m2 bid. Grade 3 arrhythmia and anemia/thrombocytopenia were observed in 1 patient each at 800 mg/m2 bid. Three patients discontinued continuous oral administration for 4 weeks at 400 and 800 mg/m2 bid. At 1,200 mg/m2 bid, 2 patients discontinued the treatment over 4 weeks for intolerable fatigue and abdominal pain, respectively. No serious drug-related toxicities have been observed. Grade 1–2 toxicity included urinary/feces discoloration, diarrhea, fatigue, anorexia, abdominal/chest pain, and edema. Tumor shrinkage was observed in 1 patient of NSCLC. In the pharmacokinetics, at any dose levels, Cmax and AUC0–t after repeated administration of TSU-68 on days 8 and 29 were ~2-fold lower that those after the first administration on day 1; these parameters are similar between days 8 and 28. In addition, no obvious dose-dependent increase in plasma exposure to TSU-68 repeatedly administered was observed over the four dose levels, including the higher dose levels. The tolerable dose in this administration schedule for continuing treatment is thought to be 800 mg/m2 or less bid." @default.
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• W2024257726 date "2010-07-30" @default.
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• W2024257726 title "Phase I and pharmacokinetic study of TSU-68, a novel multiple receptor tyrosine kinase inhibitor, by twice daily oral administration between meals in patients with advanced solid tumors" @default.
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• W2024257726 doi "https://doi.org/10.1007/s00280-010-1404-z" @default.
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