Hoffmann, R. A wiki for the life sciences where authorship matters. Nature Genetics (2008)

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Tutsch, K.D. et al.

Tutsch, Arzoomanian, Alberti, Tombes, Feierabend, Robins, Spriggs, Wilding,

Phase I clinical and pharmacokinetic study of an one-hour infusion of ormaplatin (NSC 363812).

Ormaplatin (NSC 363812, tetraplatin) is a stable platinum (IV) analog which has exhibited activity against cisplatin-resistant cell lines. A phase I trial of ormaplatin administered as a 1-h infusion every 4 weeks was performed. Forty-one patients received 101 cycles of drug over the dose range 4-128 mg/m2. The dose-limiting toxicity was reversible thrombocytopenia and granulocytopenia. Minimal myelosuppression was observed at dose levels < or = 78 mg/m2, while grade 3 or 4 myelosuppression (thrombocytopenia and/or granulocytopenia) was seen in 4/8 patients at 98 mg/m2 and 4/5 patients at 123 mg/m2. Nausea and vomiting was observed at all dose levels but was controlled with antiemetic premedication. Neurotoxicity was observed in 5/41 patients and the incidence appeared related to cumulative dose rather than to dose level or drug clearance. Platinum was measured by furnace atomic absorption spectrophotometry. Ormaplatin-derived plasma ultrafilterable platinum (UF-Pt) exhibited linear pharmacokinetics over the dose range studied. The mean total body clearance of UF-Pt was 135 ml/min/m2 and the mean elimination half-life (t1/2beta) was 13.6 h. Ormaplatin exhibited a high degree of protein binding, with more than 70% of platinum protein bound by the end of the infusion. Urinary excretion of platinum accounted for 37% of the total dose of ormaplatin in 24 hours. A phase II dose of 98 mg/m2 is recommended for testing in a patient population with cisplatin-refractory disease.[1]

References

Phase I clinical and pharmacokinetic study of an one-hour infusion of ormaplatin (NSC 363812). Tutsch, K.D., Arzoomanian, R.Z., Alberti, D., Tombes, M.B., Feierabend, C., Robins, H.I., Spriggs, D.R., Wilding, G. Investigational new drugs. (1999) [Pubmed]

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